Podcasts about GMP

In this episode of BioTalk with Rich Bendis, Jeffrey N. Hausfeld, M.D., Chairman of the Board and Chief Medical Officer of BioFactura Inc., and Darryl Sampey, Ph.D., President and Chief Executive Officer of Capitol Biologics, join the conversation to discuss the launch of Capitol Biologics as BioFactura's CDMO division. Jeff and Darryl explain how BioFactura's experience building biologics development and clinical manufacturing capabilities created the foundation for a more personalized CDMO model. The discussion explores the gap Capitol Biologics is designed to fill for emerging biotech companies that need integrated development support, scientific depth, analytical expertise, phase-appropriate quality, and early GMP manufacturing without being pushed into a large commercial-scale CDMO model too soon. The conversation also highlights what biotech CEOs and CMC leaders should consider before choosing a CDMO partner, including developability assessment, cell line and process development, analytical characterization, quality systems, cost of goods, regulatory readiness, and timing. Jeff and Darryl also discuss the growing importance of U.S.-based biologics development and manufacturing capacity, especially for emerging biotech and government-aligned programs. Editing and post-production work for this episode was provided by The Podcast Consultant. Jeffrey N. Hausfeld, M.D., M.B.A., F.A.C.S., is a physician entrepreneur, biotechnology executive, investor, and healthcare innovator whose career spans clinical medicine, life sciences, healthcare real estate development, and entrepreneurial leadership. A graduate of Yale University School of Medicine and recipient of an M.B.A. from Johns Hopkins University, Dr. Hausfeld is an Associate Clinical Professor of Surgery at George Washington University and has been actively involved in national medical societies and healthcare leadership organizations for more than four decades. He currently serves as Chairman of the Board and Chief Medical Officer of BioFactura Inc., Chairman of Capitol Biologics, and Chairman and Co-Founder of the Society of Physician Entrepreneurs. His work focuses on advancing healthcare innovation, biotechnology commercialization, physician entrepreneurship, and the responsible adoption of emerging technologies that improve patient care. Darryl Sampey, Ph.D., is a biopharmaceutical executive and company builder with more than 30 years of experience advancing biologics from discovery through clinical development and commercial manufacturing. He co-founded BioFactura in 2004 and has guided the company from start-up through incubator stages into a fully integrated biopharmaceutical product development and clinical manufacturing company. At BioFactura, he has raised more than $90 million in non-dilutive and strategic funding, built cGMP manufacturing capabilities, and led development of novel therapeutics, biodefense medical countermeasures, biosimilars, and cell therapies. Dr. Sampey is an inventor of the VeriCyte™ Discovery and StableFast™ Biomanufacturing Platforms and previously held process development and manufacturing leadership roles at Human Genome Sciences and North American Vaccine.

Good Morning Portugal!

What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushed, or under-resourced.This episode features Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefense initiatives with hundreds of millions in US government support. Milan's focus lies in streamlining drug development, from rapid molecule design to building manufacturing infrastructure, all grounded in holistic, systems-level thinking.Topics discussed:Why so many promising programs fail between discovery and the clinic, and how to close this gap through early, iterative design and testing (02:52)The practical advantages and considerations of cell-free protein synthesis for rapid prototyping and testing during development (07:30)How to decide when to deploy cell-free production versus traditional CHO systems (08:29)Recommendations for resource-constrained startups: what to focus on first and why stability and documentation matter most (10:55)Consistent success factors across Milan's experiences, from government contract projects to launching his own company (13:54)Candid stories of setbacks and lessons—such as the critical importance of safety in development and the impact of overlooked technical details like facility lighting (15:30)The importance of linking drug design decisions to target patient needs and regulatory considerations, thinking holistically, and using target product profiles to guide development (20:22)Smart insight: Perhaps the most powerful takeaway isn't technical, but personal. Staying curious, open-minded, and deriving enjoyment from the process is vital for sustaining the drive necessary for biotech's long and often unpredictable journey. The best way to bridge the valley of death in biotech is through rigorous iterative design, early testing of critical attributes, holistic planning, and a relentless commitment to learning.If you enjoyed this episode you might also like listening to:Episodes 189 - 190 : Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan SharfsteinEpisodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe LicariEpisodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannConnect with Milan Tomic:LinkedIn: www.linkedin.com/in/milan-tomic-phdAlbrem Biopharma: www.albrem.comNext Step:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

Stai comprando proteine in polvere da anni. Sai già che esistono le isolate, le concentrate, gli idrolizzati. Probabilmente controlli i grammi di proteine per dose. Ma stai guardando la cosa sbagliata.→ Amino spiking: aggiungere aminoacidi economici come arginina, glicina o creatina per gonfiare il contenuto proteico dichiarato. La matematica dell'azoto lo smonta in 30 secondi — una proteina al 143% è impossibile, eppure il fenomeno esiste e gira ancora indisturbato→ La creatina NELLE proteine viene venduta come valore aggiunto. Spesso è un riempitivo economico che altera lo spettro aminoacidico. Se vuoi la creatina, prendila separata — punto→ GMP non certifica la materia prima: certifica l'impianto di produzione. Informed Sport certifica altro ancora. La differenza è enorme e quasi nessuno la spiega chiaramente ai consumatori→ Siero dolce, siero acido, siero nativo: tre materie prime con caratteristiche completamente diverse che finiscono tutte sotto l'etichetta "whey protein isolate" — e il prezzo non basta per distinguerleDopo questo episodio non guarderai mai più un'etichetta di proteine nello stesso modo.

The gap between a “drug” and a true “product” is where many therapies fail.Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actually reach patients. His experience spans everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams align scientific innovation with the operational and regulatory realities needed for successful commercialization.Topics discussed:Milan's path from curiosity-driven research in molecular biology to biotech industry leadership (05:24)The importance of integrating work-life factors into career decisions, and balancing scientific depth with operational and business responsibilities (08:22)The unexpected role that salesmanship plays for scientists moving into entrepreneurship (10:40)Lessons from transitioning between scientific disciplines, including dealing with setbacks like unpublished graduate work (12:57)How curiosity led Milan to oversee the redesign of a 2,000-liter GMP manufacturing facility (16:16)Key advice for scientists on process design and scaling up, especially for those involved in CMC (20:18)Smart insight: A promising molecule isn't enough—successful drug development requires designing early for scalability, GMP compliance, and real patient need. Companies that align science with manufacturability and market fit are far better positioned to advance, attract investors, and secure partners.If you enjoyed this episode you might also like listening to:Episodes 189 - 190 : Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan SharfsteinEpisodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe LicariEpisodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannConnect with Milan Tomic:LinkedIn: www.linkedin.com/in/milan-tomic-phdAlbrem Biopharma: www.albrem.comNext Step:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

In this episode of Grow Sessions, Live Long and Process: GMP & the Future of Cultivation, Mark Doherty sits down with Darwin Millard—known as the “Spock of the industry”—to explore how GMP, consistency, and systems-based thinking are shaping not just today's operations, but the future direction of cultivation and processing as the industry matures.With a mechanical engineering background and a “cold and logical” approach, Darwin applies disciplined thinking to processing, summed up in his mantra: “Live long and process.” The episode covers the shift toward standardized, data-driven production and why solventless extraction is becoming a benchmark for purity and consistency in an increasingly quality-driven market.A major focus is facility design under GMP and GACP frameworks, and why even advanced operations still fail microbial standards due to avoidable design flaws like airflow, HVAC layout, and poor clean-room planning. Darwin outlines what true clean-room thinking requires—from non-porous materials to sanitation-first construction.Looking ahead, the conversation expands into what the next generation of cultivation will look like: more automated environments, tighter environmental control, real-time data monitoring, and increased alignment with pharmaceutical manufacturing standards. As markets mature, Darwin explains how operators who embrace repeatable systems, validation, and certification will be best positioned for scalability and long-term viability, while those relying on legacy methods will struggle to keep pace.The conversation also explores global regulatory pressures and how operators can navigate evolving compliance expectations while bridging pharma-grade rigor with emerging industry frameworks. Third-party certification is highlighted as a key strategy for future-proofing operations.To close, Darwin breaks down the economics of compliance—arguing that proactive investment in safety systems is not just regulatory, but essential for reducing risk, avoiding recalls, and building long-term operational resilience.Darwin Millard, CSQ (Cannabis Safety & Quality) Darwin Millard is a 18-year cannabis/hemp industry veteran, cannabinoid extraction specialist, policy change-maker, and one of Marijuana Venture's ‘40 Under 40' Executives to Watch in Cannabis. Colloquially known as “The Spock of Cannabis,” Millard has focused on the extraction and manufacturing of nutraceutical products containing cannabinoids for nearly two decades, helping companies “live long and process” by implementing cost-effective, purpose-driven phytocannabinoid processing and herbal product manufacturing solutions. Millard specializes in mechanical and solvent based extraction methods for isolating highly volatile terpenophenolic secondary metabolites from botanicals, and his expertise has progressed the cannabinoid product industry forward. In 2012, Millard took part in developing the first legally sold CBD dietary supplement and he's since worked in some capacity with every major publicly traded cannabis operator at some point in their business lifecycle.Throughout his vast industry experience, Millard learned first-hand about the need for standardization within the cannabis industries, which led him to where he is today. Now Millard champions the benefits of standardization as the Technical Director for Cannabis Safety & Quality (CSQ), the first accredited safety and quality certification program to meet ISO requirements and regulatory requirements from seed-to-sale for the manufacture of cannabinoid-containing products. In addition to his role at CSQ, Darwin is the Vice Chair of ASTM International's Committee D37 on Cannabis, a group dedicated to the development of voluntary consensus standards for the global cannabis/hemp industry.If you'd like to connect with Darwin, please email him at darwin@thespockofcannabis.com or connect with him on Linkedin.Mark Doherty, Doherty AgMark Doherty is the VP of Construction & Facilities Management for Grown Rogue, bringing over 15 years of experience in CEA and commercial cannabis cultivation. Throughout his career, he has led operations and facility development across multiple national brands, including roles as COO at Dual Draft Integrated Airflow, Exec. VP at urban-gro, and VP of Facilities Management at Vireo Growth.Through his firm Doherty Agriculture, Mark focuses on turning underperforming cultivation assets using his signature People, Plants, Profits framework—treating each facility as a living, breathing machine to drive efficiency, consistency, and profitability. He is known for combining deep technical expertise with practical leadership to elevate both.If you'd like to connect with Mark, please email him at mark.edward.doherty@gmail.com.Thanks for listening. Be sure to subscribe to our podcast to receive upcoming episodes. 

The "data lake" that was supposed to unify bioprocessing intelligence has, in most companies, become something else entirely: a data swamp, where information goes in and insight rarely comes back out. For anyone trying to deploy AI in GMP manufacturing, that is not a technical problem. It is the problem.Steffen Kreye has seen it from both sides. As former upstream development lead at Bayer and now Professor of Industrial Biotechnology at Berliner Hochschule für Technik, he brings an unusually grounded perspective on where AI in bioprocessing actually stands, what the next generation of scientists needs to be equipped with, and what industry can do right now to help close the gap.Key topics discussed:How soft skills like teamwork and self-motivation are becoming increasingly important for scientists, and strategies to foster them in education (02:47)The reality behind AI and machine learning in biotech today, including current limitations and the true state of industry adoption (05:48)Envisioning bioprocessing ten years from now: the potential of continuous manufacturing, digital twins, and automation, and the evolving diversity of bioprocesses (08:09)Practical ways industry professionals can support university education—from guest lectures to hands-on lab courses—and why it matters (10:09)Motivating students by connecting coursework to real industry roles and contributions (12:10)The importance of finding and following individual motivation in science careers (12:41)Reflections on moving from industry to academia: autonomy, challenges, and the satisfaction of seeing students grow into scientists (13:22)How strong collaboration between academia and industry leads to better innovation and prepares future scientists for success (15:53)Smart Insight: Most companies talking about AI in bioprocessing are still solving a more fundamental problem: getting their data into a state where AI could use it at all. The breakthrough will not come from the algorithm. It will come from the unglamorous, years-long work of making data accessible, harmonized, and meaningful across sites, systems, and GMP boundaries.Here are some other guests who touched on similar themes:Episodes 175 – 176 : How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine — about training the next generation of biopharma talent.Episodes 93 – 94: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer — another career pivot story from a scientist who stepped outside the traditional industry path.Episodes 111 – 112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén — very aligned with Steffen's nuanced take that AI is a tool but human expertise in bioprocessing still matters.Connect with Steffen Kreye:LinkedIn: www.linkedin.com/in/steffen-kreye-3b531183/Berliner Hochschule für Technik: www.prof.bht-berlin.de/kreyeNext Step:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

Gill Gross unpacks a couple big results from Day 1 at Roland Garros 2026. Novak Djokovic picked up his first win since March, overcoming a shaky start against Giovanni Mpetshi Perricard. Plus, Nishesh Basavareddy scored the biggest win of his career beating 7-seeded Taylor Fritz. 0:00 Intro 0:45 Djokovic def. GMP 15:50 Nishesh beats Fritz 31:55 Other Matches/News IG: https://www.instagram.com/gillgross_/TikTok: https://www.tiktok.com/@gill.gross24/7 Tennis Community on Tribe: https://tribechat.com/gillTwitter/X: https://twitter.com/Gill_GrossThe Draw newsletter, your one-stop-shop for the best tennis content on the internet every week: https://www.thedraw.tennis/subscribeBecome a member to support the channel: https://www.youtube.com/channel/UCvERpLl9dXH09fuNdbyiLQQ/joinEvans Brothers Coffee Roasters, the Official Coffee Of Monday Match Analysis... use code GILLGROSS25 for 25% off your first order: https://evansbrotherscoffee.com/collections/coffeeAUDIO PODCAST FEEDSSpotify: https://open.spotify.com/show/5c3VXnLDVVgLfZuGk3yxIF?si=AQy9oRlZTACoGr5XS3s_ygItunes: https://itunes.apple.com/us/podcast/monday-match-analysis/id1432259450?mt=2 Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

The supplement industry is pushing back. In May 2026, a group of long-tenured ashwagandha producers and regulatory experts launched the Ashwagandha Standards Alliance (ASA), a new coalition dedicated to countering misinformation about ashwagandha leaf safety, defending GMP standards, and responding to what many in the industry see as scientifically unsupported regulatory actions: India’s April 2026 FSSAI/AYUSH leaf advisory and Denmark’s earlier ban. In Episode #218 of the PricePlow Podcast, Mike and Ben sit down with Blake Ebersole, founding member of the ASA and president of NaturPro Scientific, a B2B quality and regulatory consulting firm. Blake unpacks and rejects the “root good, leaf bad” narrative, explains why in vitro cancer cell studies are being misused to target ashwagandha leaf, and details how lab shopping and supply chain fragmentation quietly erode quality across the botanical category. This episode pairs directly with our companion article on India’s ashwagandha leaf advisory. Together they cover both the regulatory deep-dive and the industry coalition response. Subscribe to the PricePlow Podcast on your favorite platform and sign up for our ashwagandha news alerts on PricePlow before diving in. https://blog.priceplow.com/podcast/ashwagandha-standards-alliance-218 Video: The Ashwagandha Standards Alliance Responds to India’s FSSAI Leaf Advisory https://www.youtube.com/watch?v=GxYGLOcgVIw Detailed Show Notes: Blake Ebersole on the Ashwagandha Standards Alliance, FSSAI, and Industry GMP (0:00) – Introductions (2:45) – What Is the Ashwagandha Standards Alliance? (4:30) – How ASA Fits the Industry Landscape (6:15) – Educational, Policy, and Standards Goals (8:00) – Adverse Events at Scale and Ashwagandha’s Safety Record (11:15) – Denmark’s Ban and the Hazard-Based Regulatory Model (15:15) – Withaferin A and the In Vitro Extrapolation Problem (18:30) – How Competitive Interests Drove the Market Off Track (21:00) – Label Disclosure, Dilution, and Maltodextrin (25:00) – The Billion-Dollar Market and Supply Chain Fragmentation (30:00) – India’s Regulatory Framework: Food, Drug, and No Middle Ground (32:15) – Farmers, Brokers, and the FSSAI Advisory’s Unintended Consequences (38:00) – Research Gaps and the Clinical Literature (41:00) – Extraction Methods: Milk, Solvents, and Withanolide Chemistry (44:30) – Consumer Education and the Demand for Transparency (46:30) – Lab Shopping and the Broken Incentive Structure (52:45) – Branded Ingredients and GMP Supplier Qualification (55:15) – ASA Founding Members: Sabinsa, Cepham, and Arjuna Natural (58:00) – Formula Ideas: Sleep, Lifestyle, and Beyond the Basics (1:00:45) – Anhedonia, Cortisol, and What the Science Says Where to Follow and Learn More Connect with Blake Ebersole and the Ashwagandha Standards Alliance LinkedIn: Blake Ebersole (founding member of the ASA and president of NaturPro Scientific) Ashwagandha Standards Alliance Website Ashwagandha Standards Alliance on LinkedIn… Read more on the PricePlow Blog

Applied Biopharm Consulting Ltd has announced a new research collaboration with the Pharmaceutical and Molecular Biotechnology Research Centre (PMBRC) at the South East Technological University (SETU) in Waterford, Ireland, to experimentally validate aspects of its artificial intelligence (AI)-driven biomolecular research programme. The collaboration is supported through the Enterprise Ireland Innovation Voucher scheme, enabling the company to access specialised laboratory expertise within the university. With strong research activity across pharmaceutical science, biotechnology and applied life sciences and supported by the Enterprise Ireland Technology Gateway programme PMBRC has developed extensive capabilities in industry-focused research and collaboration with emerging technology companies. Through this collaboration, cell-based studies will be undertaken at SETU to generate experimental data supporting the continued development of Applied Biopharm Consulting's computational viral vector engineering platform. These studies will provide experimental validation to complement the company's computational research activities. Building on its 2024 feasibility study grant and the subsequent Intellectual Property (IP) Start Grant awarded in 2026 under Enterprise Ireland's IP Strategy initiative, Applied Biopharm Consulting continues to expand its internal research and development programme focused on next-generation viral vector engineering. The Innovation Voucher collaboration represents the next step in translating computational research into experimentally validated technologies while supporting the company's ongoing intellectual property strategy. Applied Biopharm Consulting's research programme integrates artificial intelligence, structural bioinformatics and molecular simulation techniques to analyse large datasets of protein structures and explore novel biomolecular interactions. These computational approaches are being applied to explore new strategies for viral vector design relevant to advanced biologics and gene therapy development. Dr. Anthony Newcombe, Managing Director of Applied Biopharm Consulting Ltd, commented: "Establishing a research collaboration with South East Technological University represents an important step in advancing our viral vector engineering programme from computational design toward experimental validation. The Innovation Voucher scheme enables us to access specialised academic expertise and laboratory capabilities that complement our computational research platform." Dr Niall O'Reilly, Centre Director of the PMBRC added: "We are pleased to collaborate with Applied Biopharm Consulting on this research initiative. Partnerships between academia and industry provide valuable opportunities to translate innovative ideas into experimentally validated technologies, and this project highlights how academic research capabilities can support emerging biotechnology innovation. This collaboration also fits well into our current research portfolio in areas such as gene therapy and biomedical science" The collaboration represents the next stage in Applied Biopharm Consulting's internal research and development (R&D) programme, which combines computational biologics research with experimental validation and intellectual property development. Alongside its research activities, Applied Biopharm Consulting continues to support global biopharmaceutical companies in GMP compliance, Regulatory CMC, Manufacturing Science & Technology (MSAT), Quality Assurance and technology transfer. By integrating extensive regulatory and manufacturing expertise with next-generation biologics engineering capabilities, the company is positioning itself at the intersection of advanced therapy development and biologics innovation. See more stories here. More about Irish Tech News Irish Tech News are Ireland's No. 1 Online Tech Publication and often Ireland's No.1 Tech Podcast too. You can find hundreds of fantastic previous episod...

Small Cap Breaking News You Can't Miss!Here's a quick rundown of the latest updates from standout small-cap companies making big moves today:Nextech3D.ai (CSE: NTAR) (OTCQB: NEXCF) (FSE: 1SS)Nextech3D.ai announced it will be lead sponsor at an EMRG Media trade show event in New York City (October 27-29, 2026), showcasing its Krafty Labs Experience Marketplace and AI Event Operating System. The company's Eventdex platform will handle full event registration, lead retrieval, and onsite operations. For investors, this partnership demonstrates real-world commercial traction for Nextech's unified AI Event OS as a revenue-generating platform.MAX Power Mining Corp. (CSE: MAXX) (OTC: MAXXF) (FSE: 89N)Eric Sprott is making a $25 million strategic investment in MAX Power Mining via a non-brokered private placement at $2.00 per unit, with warrants exercisable at $2.75 for 24 months. Proceeds will accelerate follow-up drilling at the Lawson Complex — Canada's first confirmed subsurface Natural Hydrogen system — along with seismic data acquisition and AI platform development. Sprott's continued backing marks a high-profile endorsement of Natural Hydrogen as a scalable clean energy frontier.Aldebaran Resources Inc. (TSX-V: ALDE) (OTCQX: ADBRF)Aldebaran reported strong infill drill results from its 80%-owned Altar copper-gold project in Argentina, highlighted by 1,339.30 metres grading 0.45% copper equivalent, including 500 metres of 0.71% CuEq. Seven holes confirm the scale and grade continuity of one of the Americas' largest undeveloped porphyry copper systems. An updated resource estimate is targeted for Q3 2026, paving the way for a Pre-Feasibility Study in 2027.Decibel Cannabis Company Inc. (TSXV: DB) (OTCQB: DBCCF)Decibel reported Q1 2026 net revenue of $30 million, a 41% year-over-year increase, with international sales surging 330% to $9.6 million as it began shipping GMP-extracted product into Germany. Adjusted EBITDA doubled to $6.9 million year-over-year, and Q2 2026 guidance calls for $33 to $35 million in revenue. A new $61 million ATB credit facility extending maturities to 2030 and a planned Creston property sale further strengthen the balance sheet heading into the seasonally strongest period.Bottom Line: Today's small-cap market featured a powerful combination of catalysts — a major institutional endorsement of Canadian Natural Hydrogen, compelling copper-gold drill results confirming a world-class deposit, strong cannabis revenue growth driven by international expansion, and an AI event technology platform winning real commercial partnerships.Stay ahead of the market — follow AGORACOM for more breaking small-cap news and insights.

Episode 450 | Interview with Grandmaster Park (GMP) Podcast Description Episode 450 is a sit-down conversation with Grandmaster Park (GMP) — a longtime friend of the show and someone who's helped shape the modern martial arts school industry. We go back to the “old days” when billing companies took a painful cut just to collect tuition, and we talk about how the industry has changed — not just in technology, but in parent expectations, communication, staff culture, and what it takes to build something that lasts. Along the way, GMP shares a few simple (but powerful) mindset shifts: how to stop letting “scorpions” steal your peace, why COVID was a reset button for the industry, how to train staff like you train students, and why school owners have to start thinking about retirement and exit plans like real entrepreneurs. We also dig into AI — not as a gimmick, but as a tool that rewards school owners who learn how to ask better questions, document their story, and build systems faster than ever. Key Takeaways The industry used to pay a “tuition tax” — and most owners don't realize how far we've come.Back in the day, schools were heavily dependent on billing companies to collect tuition, and the fees could be brutal. The bigger point: when you've lived in a new normal long enough, you forget how much friction you used to tolerate. Parents don't automatically trust the instructor the way they used to — so communication has to evolve.What worked 20–30 years ago (“Just do this at home and they'll do better in class”) doesn't always land today. The message still matters, but the delivery has to be clearer, more intentional, and more repeatable. Not everything is controllable — and the scorpion story is a gut-check for school owners.GMP shares the classic “scorpion and the frog” story: some people sting because it's in their nature. The lesson isn't to become cynical — it's to stop being surprised, protect your energy, and choose your circle wisely. COVID was a reset button — and the schools that survived often leveled up.GMP's take is blunt: a shakeout happened. Some schools closed that didn't deserve it, but many that survived did so because they had a real foundation, real systems, and the discipline to prepare for “winter.” If you're living tuition-to-tuition as a business owner, something is off.GMP challenges the idea that entrepreneurship should feel like paycheck-to-paycheck. He points to basic discipline: track spending, cut the leaks, and start investing for the future. Compound interest is the “eighth wonder of the world” — but only if you actually use it.The conversation hits on index funds (like the S&P 500), performance-based investing vs. cash sitting idle, and simple retirement vehicles (like a SIMPLE IRA) that can help owners and staff build long-term stability. Train your staff the same way you train your students: white belt to black belt.One of the biggest paradigm shifts in the episode: school owners already know how to build a curriculum that takes a beginner to black belt — but they don't apply that same thinking to staff. GMP's challenge: build a staff playbook and training path with clear expectations, checkpoints, and “retests.” If a student doesn't know the form, they don't move on. Staff training should work the same way. Some “student problems” are actually teaching mistakes.The left/right example is a perfect reminder: if the student can't process the instruction, the teacher has to change the approach. Color patches. Better cues. Different framing. The responsibility is to keep improving the delivery. Failure isn't the enemy — but you have to teach the culture around it.GMP and Allie talk about how Eastern philosophy treats failure as part of success, while many parents/students hear “failure” as “you are a failure.” Clear guidelines, expectations, and the way you deliver feedback matters. AI rewards the owner who learns how to ask better questions.GMP calls AI a new gold rush. The shift is from hunting for answers to learning how to prompt well. Start simple. Talk to it. Use voice mode. Feed it your story and your values — then let it help you build systems, onboarding, curriculum, and communication faster. Exit planning is coming to martial arts — whether owners are ready or not.GMP points out that private equity is paying attention to children's activity businesses (including martial arts). That makes “exit” a real conversation — but it starts with getting your house in order. Action Steps for School Owners Do a quick “leak audit” this week.Pick one recurring expense you've normalized (subscriptions, food runs, convenience spending) and calculate what it costs per month. Decide what you're keeping, what you're cutting, and what you're redirecting into savings/investing. Create a “Close the Dojo” shutdown routine — but for your finances.Set a weekly 15-minute money check-in: revenue, expenses, cash on hand, and one action to improve next week. Build a staff curriculum outline (one page is enough to start).Write the stages of staff development like belts: New hire (white belt): basics + values + front desk standards Assistant instructor: class support + parent communication Lead instructor: full class ownership + retention responsibilities Manager: systems + team leadership Add “retests” to your staff training.Pick one skill that keeps breaking (phone scripts, intro tours, enrollment conversations, attendance follow-up). Create a simple checklist and re-train until it's consistent. Fix one teaching mistake you keep repeating.If you keep saying the same thing and getting the same blank stares, change the cue. Change the visual. Change the framing. Don't keep “punching the same wall.” Start using AI daily for one small business task.Don't overcomplicate it. Pick one: Draft a parent email Create an onboarding checklist Write a staff training outline Brainstorm a retention campaign The goal is reps — not perfection. Write down your “exit plan” in one paragraph.Even if it's messy. Do you want to sell? License? Hand it to a team member? Reduce teaching hours? The point is to stop pretending you'll “figure it out later.” Additional Resources Mentioned Index funds / S&P 500 (as an example of performance-based investing) SIMPLE IRA (as an example of a retirement vehicle for small businesses) PCP (Praise–Correct–Praise) and positive reframing/deflection as communication tools Note: A book by Tony Graff is mentioned in the conversation, but the exact title wasn't confirmed in the transcript.

In this episode of Bench to Bedside, Dr. Roy Jensen welcomes Dr. Joseph McGuirk, division director of Hematologic Malignancies and Cellular Therapies at The University of Kansas Cancer Center, to discuss CAR T-cell therapy and the growing "CAR T crisis" in access. Dr. McGuirk explains how CAR T is made from a patient's own T cells and why it has produced unprecedented, potentially curative outcomes in blood cancers such as diffuse large B-cell lymphoma, leading to FDA approvals in second- and third-line settings. He shares national data showing only 25% of eligible second-line patients and 35% of eligible third-line patients receive CAR T, with access declining as distance from a treatment center increases. The conversation highlights barriers including referral patterns, education gaps, logistics, socioeconomic factors, and disparities, and outlines KU's efforts to expand outreach, partner with community sites, and build infrastructure to improve timely evaluation and treatment. 00:00 Welcome and the CAR T Crisis 01:25 How CAR T works 05:00 Breakthrough results and approvals 06:52 The access gap data 10:16 Why delays are deadly 11:49 Barriers to referral and equity 17:31 Taking CAR T closer to home 19:37 What patients can do now 22:22 Rapid evaluation and parallel workflow 24:26 New cancer center and GMP expansion 28:46 Closing thoughts and resources Links from this Episode:  Learn more about CAR T treatment at KU Cancer Center Learn more about Dr. Joseph McGuirk Read Dr. McGuirk's research "Real-world treatment patterns and survival outcomes in second and third line settings in large B-cell lymphoma (LBCL)" Read Dr. McGuirk's article "Leading Oncologist Rings the Alarm Bell: 'We Have a Crisis in Life-Saving Access to CAR T-Cell Therapy' Hear Dr. McGuirk talk about CAR T access on KCUR's "Up to Date" podcast To ensure you get our latest updates, follow us on the social media channel of your choice by searching for KU Cancer Center.  

What does it take to move pharmaceutical innovation from a university lab into the hands of the people who actually need it? And what happens when scientists stop waiting for “perfect conditions” and start building anyway?In this part II episode of Monday Science, Dr. Bahijja Raimi-Abraham sits down with Prof Margaret Ilomuanya to explore the realities of pharmaceutical innovation, research leadership, and in-country manufacturing in Nigeria. From compounding creams in buckets inside a small office to leading MedAfrica GMP Laboratories, the first GMP facility domiciled within a university in West Africa this conversation is ultimately about vision, persistence, and the power of starting small.But this episode also goes deeper than infrastructure or funding. It explores the mindset behind scientific progress. The role of collaboration. The importance of communicating African science more visibly. And the tension between barriers that exist on paper and the opportunities that emerge when researchers focus on solutions instead of limitations.Follow us @MondayScience #mondayscience #mondaysciencepodcastFind out more www.mondaysciencepodcast.com Get in touch mondaysciencepodcast@scientificallyspeakingglobal.comJoin the newsletter https://forms.gle/e1KWqp5H6x14k9pV9

We love to hear from our listeners. Send us a message.In episode 128, Host Erin Harris talks to Tatyana Matveeva, Ph.D., Director of cGMP Operations at George  A. "Doc"  Lopez, MD Laboratory for Regenerative Cell Therapy, Harvard Medical School and Massachusetts General Hospital, about leading cGMP operations within an integrated ecosystem, where manufacturing, research, and neurosurgery coexist. Dr. Matveeva highlights key operational challenges in scaling autologous therapies, particularly around technology transfer, process reproducibility, and regulatory readiness, emphasizing the need for early collaboration between research and GMP teams. Their conversation also explores rigorous approaches to chain of identity and custody, the importance of extensive simulation runs to ensure robustness, the unique sensitivities of manufacturing cells for neurological applications, and more.Subscribe to the podcast!Apple  |  Spotify |  YouTubeVisit my website: Cell & GeneConnect with me on LinkedIn

When every batch belongs to a single patient, a single centralized facility cannot serve the world. In Part 2, Chantale Bernatchez moves from process development into the broader consequences of that reality: the manufacturing model built around clinical proximity, the global alliance bringing TIL production to regions with no current access, and the next-generation engineered approaches redefining what these therapies can do.Chantale Bernatchez is Head of Process Development at CTMC, a joint venture between Resilience and MD Anderson Cancer Center. If you missed Part 1, she explained how specific activation changes recovered a failing TIL process from 50% to 95% success in heavily pre-treated patients.Topics discussed:How close collaboration with MD Anderson accelerates clinical development and regulatory readiness (03:08)CTMC's approach to process development and adapting to innovative technologies (05:15)The value of partnership-based models versus traditional CDMO-driven approaches (06:24)Global technology transfer: building alliances to expand access to cell therapies, with a case study in Brazil (07:35)Key barriers and solutions for cell therapy manufacturing in new regions (09:41)Practical advice for scientists starting in GMP manufacturing and process development (10:46)Future directions in CAR T and TIL, including logic-gated CARs, engineered TILs, and in vivo therapies (12:24)The importance of continued innovation and collaboration to expand global patient access (17:39)Smart insight:The choice of manufacturing partner in cell therapy is not a logistics decision. It is a process development decision. CTMC's collaboration-based model exists because many early-stage developers arrive without a process robust enough to hand over. For scientists in small or mid-sized companies, engaging that kind of partnership too late, or on purely transactional terms, is one of the most avoidable risks in early clinical development.If you're interested in exploring further the concepts we touched on, such as cell therapy manufacturing, process control, and scaling living therapies—take a look at these related discussions:Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon ShareiEpisodes 109 - 110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerConnect with Chantale Bernatchez:LinkedIn: www.linkedin.com/in/chantale-bernatchez-22b09511CTMC website: www.ctmc.comSupport the show

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style standard. Instead, Q10 is designed to augment regional GMPs and provide a lifecycle model for managing pharmaceutical quality.Using the Annex 2 PQS diagram, Subhi walks through how Q10 applies across pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. The episode discusses phase-appropriate GMP expectations, why Q10 does not replace GMP, and how management responsibility spans the full lifecycle, including outsourced activities and purchased materials.The episode also covers the four core PQS elements: process performance and product quality monitoring, CAPA, change management, and management review. These elements are presented as operational loops that help maintain control and drive improvement. Subhi also highlights the two key enablers of the model: knowledge management, connected to ICH Q8, and quality risk management, connected to ICH Q9.The episode closes with Section 4 of Q10, which focuses on continual improvement of the PQS itself, including management review inputs, external changes, resourcing, documentation, and communication.00:00 Welcome and Series Setup00:14 Why ICH Q10 Matters01:21 Lifecycle and Phase-Appropriate GMP02:23 GMP Foundation and the PQS Model02:58 Management Responsibility03:31 Core PQS Elements04:26 Enablers: Knowledge Management and QRM04:40 Guideline Walkthrough: Sections 1 to 306:37 Continual Improvement of the PQS07:45 Wrap Up and Next EpisodeSubhi Saadeh is the Founder and Principal at Let's Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.

The most underappreciated parameter in cell therapy process development is not your bioreactor, your media, or your activation protocol. It is the patient. Chantale Bernatchez has spent 20 years learning that lesson the hard way, watching the same manufacturing process succeed brilliantly with one donor and fail completely with the next. In this episode, she explains why starting material variability is the defining challenge of cell therapy manufacturing, and what it actually takes to build a process robust enough to survive it.Chantale Bernatchez is Head of Process Development at CTMC, a joint venture between Resilience and MD Anderson Cancer Center. She holds a PhD in immunology and has spent two decades advancing T cell therapy from early research programs at MD Anderson to GMP-compliant clinical manufacturing. She holds four patents in adoptive cell therapy.Key topics discussed:Personal journey: from immunology PhD in Quebec to cell therapy leadership in Houston (04:25)Evolution of TIL therapy at MD Anderson, including manufacturing innovations to overcome declining T cell yields (06:14)The fundamental differences between traditional medicines and cell-based immunotherapies (10:01)Unique manufacturing complexities for autologous therapies, including batch variability and process standardization (11:19)Strategies to address decreased cell fitness in heavily pretreated patients, including changes in cell activation and culture conditions (13:57)Key learnings from the CAR T and TIL manufacturing process: balancing process duration, cell fitness, and product yield (16:28)Mechanistic differences between CAR T and TIL therapies and their implications for efficacy and resistance (17:58)The limits and risks of automation in cell therapy manufacturing—balancing manual vs. automated processes (24:04)Why moving between manufacturing platforms raises challenges in comparability and clinical outcomes (25:44)The ongoing search for critical cell quality attributes that correlate with patient response (27:00)In part two, Chantale goes deeper into next-generation approaches, technology transfer, and what needs to change to broadly expand patient access.Smart insight: In cell therapy, manufacturing isn't just a production step. It defines the therapy itself. Because each patient's starting cells are unique, even subtle changes in the process can significantly alter clinical outcomes.If you're interested in exploring further the concepts we touched on—such as cell therapy manufacturing, process control, and scaling living therapies—take a look at these related discussions:Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon ShareiEpisodes 109 - 110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerConnect with Chantale Bernatchez:LinkedIn: www.linkedin.com/in/chantale-bernatchez-22b09511CTMC website: www.ctmc.comSupport the show

Licensed medical cannabis has officially moved from Schedule I to Schedule III, but most operators still don't fully understand what changed, what didn't, and where the real risks and opportunities are. In this episode of Cultivation Elevated, host Michael Williamson sits down with cannabis attorney Christine Seney for a no-fluff breakdown of what rescheduling actually means on the ground, financially, operationally, and strategically.Christine works directly with MSOs, investors, and executive teams on licensing, compliance, deal structure, and capital strategy across multiple state markets. This is not outside commentary. This is real-time legal strategy.Timestamps:0:00 Introduction1:44 The most costly misconception operators have about Schedule III2:23 Medical vs. adult use: an expensive distinction3:54 Is this a tax issue, a compliance issue, or both?4:03 What MSO CFOs should be doing right now around 280E4:26 The 60-day DEA filing window explained5:16 Biggest missed opportunities in the next 6 to 12 months5:49 Import/export opportunities and FDA recognition6:13 Pharma partnerships and health insurance coverage for patients7:19 Banking, capital access, and legitimizing the industry8:47 Uplisting, credit card processing, and reducing transaction friction9:32 Why insurance coverage for medical patients would be a game changer10:01 Michael's 18 years as an operator and the real cost of medical cannabis therapy11:14 Does rescheduling actually change enforcement risk?11:30 Why DEA enforcement is coming and what it will look like13:10 How federal and state agencies work together on enforcement (Florida example)13:45 What has NOT changed that people think has14:37 IRS guidance still pending, travel caution still applies15:45 The "meaningful domino" analogy16:05 Winners and losers of rescheduling17:06 The CHAMPS case and mixed-license businesses18:27 Why new entrants have a strategic advantage right now19:13 Florida as a case study: medical-only, vertical integration, capital intensity20:46 Could Schedule III actually hurt parts of the cannabis industry?21:28 Big tobacco, big alcohol, and consolidation risks22:33 The craft operator opportunity and why smaller players can still win23:08 GMP, FDA oversight, and pharmaceutical standards coming to cultivation24:27 ASTM cannabis standards and what operators should be watching24:38 The next 3 legal and regulatory dominoes to watch25:15 Adult use descheduling, cartel policy, and the political path forward25:46 Hemp vs. cannabis and whether the two sides eventually collapse together26:23 Closing thoughtsKey topics covered: Cannabis rescheduling, Schedule III cannabis, 280E tax reform, DEA registration, medical marijuana compliance, MSO strategy, cannabis investment, GMP cannabis, FDA cannabis, cannabis banking, SAFE Banking, cannabis enforcement, cannabis legalization, hemp vs cannabis regulation, cannabis tax planning, multi-state operatorsGuest: Christine Senne is a cannabis attorney at Grossman, Roopnarine & Bayó, LLC, where she focuses on regulatory strategy, compliance, and complex business structuring across multiple state markets. She advises operators, investors, and executive teams on navigating licensing, enforcement risk, multi-state expansion, and capital strategy in one of the most highly regulated industries in the country.Christine is known for translating complex legal and regulatory frameworks into clear, practical guidance that operators can execute against. Her work sits at the intersection of law, policy, and real-world operations, making her a trusted advisor to companies scaling in dynamic and often uncertain environments.With the recent shift to Schedule III, Christine is actively working with clients to interpret and respond to this regulatory change in real time, providing critical insight into both the immediate implications and long-term strategic considerations for cannabis operators.Connect With PippPipp Horticulture Website - https://pipphorticulture.com/Pipp Horticulture YouTube - https://www.youtube.com/channel/UC4nNnNCiwS5k5GX7BaXIrbAPipp Horticulture - Facebook - https://www.facebook.com/pipphorticulturePipp Horticulture Instagram - https://www.instagram.com/pipphorticulture/Pipp Horticulture LinkedIn - https://www.linkedin.com/company/18333737/Pipp Horticulture Pinterest - https://www.pinterest.com/pipphorticulture/

Guest: Dr. Andrew Gaffney is Vice President, iPSC Platform at STEMCELL Technologies. In this episode, he discusses how his team is advancing pluripotent stem cell applications through high-quality iPSC line development, gene editing, organoid production, and GMP manufacturing for translational and clinical use. He also highlights key challenges in the field, including reproducibility, standardization, genetic diversity, and freedom-to-operate considerations, and explains how these factors impact the path from basic research to commercialization. Featured Products and Resources: Explore STEMCELL Technologies’ one-stop resource for organoids. Join us at ISSCR 2026 and be part of the global conversation shaping the future of stem cell research. The Stem Cell Science Round Up Transgene-Free Gastrulation Model – Scientists have produced a transgene-free stem cell model that recreates key features of human peri-gastrulation, including germ layer formation and early hematopoiesis. Engineering Antibody-Producing Stem Cells – CRISPR-edited hematopoietic stem cells generate B cells that produce durable, protective antibodies following vaccination. Safeguarding Chemical Reprogramming – Investigators have found that p53 is required for efficient chemical reprogramming by maintaining genomic stability and regulating early cell state transitions. Targeting Barriers to Cardiac Repair – Knockdown of calreticulin enhances cardiac reprogramming and improves heart repair after injury. Photo Reference: Courtesy of Dr. Andrew Gaffney Subscribe to our newsletter! Never miss updates about new episodes. Subscribe

Joining us or the first time on the breakfast show, it's Natasha Donn in her new bi-monthly residency,with her take on the Portuguese news, which she analyses and writes every day for The Portugal Resident!Also joining us, Lidia Alves, who can help! Yes, she gets things done and makes things happen to help you "feel at home in Portugal".Hang out with the GMP! community and answer the quiz question at https://www.skool.com/gmp-vips-1236Carl's new website - https://portugaltalk.com/Become a supporter of this podcast: https://www.spreaker.com/podcast/the-good-morning-portugal-podcast-with-carl-munson--2903992/support.Get help moving to and living in Portugal

Have an idea for an episode? Contact us!XDemics is the 2026 SLAS Ignite Award winner, and we're joined by members of the team: Colin Cook, PhD (CTO & Co-Founder), Daniel Downie (Manager, Sales and Commercial Development), and Nicholas Scianmarello, PhD (VP Manufacturing), to discuss their respiring membrane technology.They discuss applications in viral vector manufacturing, cell banking, T-cell and stem cell culture, and exosome production, emphasizing compatibility with automation and the ability to scale from 96-well plates to GMP bioreactors.Key Learning Points:XDemics' respiring membrane technologyApplications in viral vector manufacturing and exosome productionImpact on cell culture efficiency and automationRecognition and future plans after winning the SLAS Ignite AwardAbout XDemicsXDemics, a Caltech spinout, is fundamentally improving the way cells are grown. We've addressed a primary bottleneck—the basic inability to efficiently transfer oxygen in media during cell growth.Stay connected with SLAS:www.slas.org | Facebook | X | LinkedIn | Instagram | YouTubeAbout SLASSLAS (Society for Laboratory Automation and Screening) is an international professional society of academic, industry and government life sciences researchers and the developers and providers of laboratory automation technology. The SLAS mission is to bring together researchers in academia, industry and government to advance life sciences discovery and technology via education, knowledge exchange and global community building. Upcoming Events:SLAS Europe 2026 Conference and Exhibition (19-21 May 2026 | Vienna, Austria)SLAS Meet-UpsChicago, Illinois (June 18, 2026)Leiden, Netherlands (10 September 2026)Tübingen, Germany (20 October 2026)SLAS 2026 Sample Management Symposium (October 21-22, 2026 | South San Francisco, California)SLAS2027 International Conference & Exhibition (January 30 - February 3, 2027 | San Diego, California)View the full events calendar

She's back (from outer space?): GMP!'s AI assistant Gumpetta returns for a good quizzing, and for his first time on the show from Xtracars - Gonçalo Tordo - with some deals on wheels!Plus the Portugal Club Quiz - https://www.skool.com/gmp-vips-1236Become a supporter of this podcast: https://www.spreaker.com/podcast/the-good-morning-portugal-podcast-with-carl-munson--2903992/support.Get help moving to and living in Portugal

In this episode, COO of Lumino recruitment and show host, Nikita Cretu, sits down with Timo Bongartz for an in-depth conversation recounting how Timo convinced a global lighting giant to make its entry into the cannabis industry, his journey into cannabis, what he is up to in his new role at Kündig, his philosophy for building a close-knit, high performing team, and discussing bottlenecks in the global cannabis supply chain.We're sure this episode will be a treat for many.Timo Bongartz is the Managing Director of Kündig Pharmaceutical Solutions (KPS), a GMP-certified contract processing unit within the Kündig Group serving the medical cannabis and pharmaceutical supply chain.With over 15 years of experience in business transformation, corporate strategy, and venture building, Timo has shaped companies at the intersection of technology, cultivation, and life sciences. His career spans leadership roles as CEO of Cannavigia and General Manager at Fluence, where he helped cultivators scale through software, data, and advanced lighting technology.❇️ Get in touch at https://www.thecannabisconversation.co.ukConnect with Nikita Cretu on LinkedIn:https://www.linkedin.com/in/nikita-cretu-b24b83a8/Connect with Thomas Gray on LinkedIn:https://www.linkedin.com/in/thomas-c-s-gray/

Shear sensitivity is the silent challenge behind many advanced biomanufacturing modalities. Orbital-shaken bioreactors—often underestimated—may be a key enabler your CMC development is missing.Tibor Anderlei, CSO at Kühner Shaker, joined David Brühlmann on the Smart Biotech Scientist Podcast to unpack the hidden physics behind bioprocess reproducibility and next-generation shaking technology. He has seen firsthand how overlooking fundamental parameters can derail scale-up and delay development timelines. In his role, Tibor is responsible for the customer interface—spanning sales, service, support, GMP topics, troubleshooting, marketing, and applied technology—with a focus on orbital shaking technology and small-scale cultivation support.Topics discussed:The importance of measuring oxygen transfer rate (OTR) and carbon dioxide transfer rate (CTR) for reproducible bioprocesses—why DO is not sufficient (02:55)Real-time process analytical technology (PAT) for small-scale bioreactors, including microtiter plates and shake flasks (06:47)Pre-culture reproducibility: transferring at the right OTR and its impact on main cultures (07:56)Price sensitivity and scale-up challenges in cultivated meat—implications for media and equipment selection (10:36)Expansion of shaking technology to fields such as mixing, storage, and thawing, including applications in liquid crystal production (12:10)Leadership lessons from competing with bigger players: how smaller companies stay innovative, agile, and close to their customers (14:20)The significance of strong business partner relationships and trusting gut feeling in decision-making (16:32)Key advice for smart biotech scientists: careful definition of screening conditions and the use of online measurement tools at small scale (18:09)Accessible resources for mastering shaken bioreactor techniques, including webinars and direct contact with Tibor Anderlei (19:38)Smart insight:Treat small-scale shaken systems as real bioreactors and define screening conditions carefully from the start. Using online measurement tools even at early stages provides critical visibility and helps ensure that results are reproducible and scalable.Building a robust scale-up strategy requires looking at the process from multiple angles—regulatory, digital, and operational. Listen to those previous episodes:Episode 03 - 04: How to Master Biotech Scale-up Without Guesswork with Leonardo SibilioEpisode 25 - 26: 9 Critical Steps for a Seamless Transition to Large-Scale ProductionEpisode 231-232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannEpisode 233-234: Why Most Bioprocess Automation Projects Fail with Anthony CatacchioEpisode 237-238: High-Throughput Microbial Screening with Sebastian BlumConnect with Tibor Anderlei:LinkedIn: www.linkedin.com/in/tibor-anderlei-66342411/Kühner Shaker website: www.kuhner.comShaking Technology Forum: www.shakingtechnology.comSupport the show

Most cannabis companies in the global supply chain aren't failing because of regulation — they're failing because they're running businesses like magpies. Chasing whatever's shiny. No strategy.In this episode of the Cannabis Accounting Podcast, host Raymond Guns sits down with Atiyyah Ferouz, founder and CEO of AgCann Consultancy and one of the most globally connected compliance experts in the cannabis industry, to break down what really happens when producers try to move cannabis across borders — and why chasing the "export" buzzword is quietly bankrupting small operators.Atiyyah has been in cannabis since Canada's 2018 legalization, starting as a tissue culture lab manager, scaling up to run a million-square-foot greenhouse, and then launching AgCann in 2020 with just $10,000 in the bank. Today she runs five cannabis businesses across three continents, is a certified pharmaceutical GMP professional, and has advised producers in emerging markets from Thailand to Colombia to Germany.Atiyyah talks about:

In this episode, host Etienne Nichols sits down with industry veteran Mike Drues to explore a critical theme in modern MedTech: the danger of "not knowing what you don't know." The conversation centers on the growing trend of companies making avoidable, "boneheaded" mistakes despite a robust regulatory framework. Mike Drues emphasizes that while technology evolves, the fundamental responsibility for safety and effectiveness remains non-delegable.The discussion dives deep into a landmark regulatory event: the first-ever FDA warning letter issued to a company for GMP violations specifically linked to the unauthorized use of Artificial Intelligence in manufacturing. They break down the legal and ethical implications of relying on AI agents to generate specifications and production records without human oversight or process validation.Finally, the episode tackles the controversial idea of individual accountability in regulatory citations. Etienne and Ryan debate whether naming specific professionals in warning letters would curb the repeat of industry-wide errors or if internal company culture provides enough of a corrective force. It's a sobering look at why professionals must keep their "brains at the door" and treat AI as a tool, not a replacement for human judgment.Key Timestamps00:02:15 - The "Preamble to the QSR": Why the "why" behind the regulation is more important than the "what."00:04:10 - The Non-Delegable Rule: Why AI agents cannot hold responsibility for quality requirements.00:07:30 - Case Study: The first FDA warning letter for AI-related GMP violations (Pure Parolia).00:10:45 - The Quality Unit: Does the "Quality Unit" legally need to be a human being?00:15:20 - Individual Accountability: The debate over naming names in official FDA warning letters.00:20:45 - The Autopilot Metaphor: Comparing AI in surgery to autopilot in aviation and self-driving cars.00:23:10 - Star Trek's "The Ultimate Computer": Lessons from 1968 on over-delegating to technology.00:27:15 - ClinicalTrials.gov: Analysis of the 30% non-compliance rate in clinical trial reporting.Quotes"The responsibility for meeting these requirements may not be delegated, even though the actual work may be delegated. This applies to artificial intelligence agents." - Mike Drues"True knowledge is knowing what you know and knowing what you don't know, and most importantly, knowing the difference between the two." - Mike DruesTakeawaysRead the Preambles: Don't just follow the letter of the QMSR; read the Preambles to understand the FDA's underlying logic and "thinking."AI is an Intern, Not a Manager: Treat AI as a "PhD-level intern." It can draft justifications or specifications, but it cannot "approve" them.Validate the AI Process: If AI is integrated into manufacturing or quality decisions, it requires process validation just like any other automated system.Human-in-the-Loop: Maintain a "Human-in-the-Loop" protocol for all regulatory submissions to prevent "garbage in, garbage out" errors.Check Clinical Reporting: Ensure all required clinical trial results are published on ClinicalTrials.gov; nearly a third of the industry is currently failing this basic requirement.ReferencesFDA Preamble to the QSR: The foundational text explaining the "why" behind quality regulations.21 CFR Part 211.22: The regulation defining the responsibilities of the Quality Control Unit.Pure Parolia Warning Letter: The April 2026 citation regarding AI and process validation.Star Trek Episode 24 ("The Ultimate Computer"): A cultural cautionary tale on over-reliance on machines.Etienne Nichols' LinkedInMedTech 101: Process ValidationThink of Process Validation like a recipe for a cake. If you're a baker, you don't just hope the cake turns out right every time; you test the oven temperature, the mixing time, and the ingredients to prove that if you follow the steps, you get a perfect cake 100% of the time.In MedTech, when a company uses AI to make decisions or manufacture parts, they must "validate" the process. This means proving that the AI (the oven) works correctly and consistently before selling the product. Claiming "the AI didn't tell me I had to test it" is like a baker saying they didn't know they had to turn the oven on because the recipe didn't mention it.Feedback Call-to-ActionWe want to hear from you! Do you think the FDA should start naming names in warning letters? Should the "Quality Unit" be legally required to be a human? Send your thoughts, reviews, or suggestions for future topics to podcast@greenlight.guru. We read every email and pride ourselves on providing personalized responses to our community.SponsorsThis episode is powered by Greenlight Guru. In an era where you cannot delegate your quality responsibility to AI, you need tools that empower your human experts. Greenlight Guru's QMS (Quality Management System) and EDC (Electronic Data Capture) solutions provide the "regulatory logic" and data integrity needed to ensure your team stays compliant, from clinical trials through post-market surveillance. Connect your quality processes and clinical data seamlessly to avoid the "boneheaded mistakes" discussed today.

As demand for DNA and RNA therapeutics continues to accelerate, manufacturers are under increasing pressure to improve efficiency, reduce risk, and scale production without expanding facility footprints. One emerging solution is the integration of traditionally separate downstream steps into a single automated platform. Asahi Kasei Bioprocess, has addressed this need with the THESYS® platform, a suite of oligonucleotide manufacturing technologies designed to streamline workflows from synthesis through downstream processing. In a recent podcast, Sagar Bhatt, Senior Project Engineer at Asahi Kasei Bioprocess America, discussed the development of an integrated system within the THESYS C&D/TFF system combines cleavage, deprotection (C&D), and tangential flow filtration (TFF), and why this shift represents a meaningful evolution in oligonucleotide manufacturing. Rethinking a Fragmented Workflow Historically, oligonucleotide production has relied on a series of disconnected unit operations. Cleavage, deprotection, ultrafiltration, and diafiltration are often performed across multiple systems, sometimes even in different rooms. “Cleavage and deprotection are often carried out using fairly basic setups… and in many cases, they still involve a lot of manual handling,” Sagar explained. “They also typically require additional equipment, like separate tanks, which adds complexity to the process.” This fragmented approach introduces several challenges. Material transfers between systems increase processing time and create opportunities for product loss. In addition, deprotection reactions, particularly for RNA, require careful thermal control due to heat generated during acid addition. “If the rate of the acid addition and resulting temperature rise are not controlled carefully, it can negatively impact the product… and damage product quality.” Facility constraints add another layer of complexity. Because oligonucleotide processing often involves flammable solvents, operations must occur in hazardous environments. However, traditional filtration systems are not typically designed for these conditions, forcing manufacturers to physically move material between areas. Recognizing these inefficiencies, Sagar and his team saw an opportunity to simplify. “By integrating these operations into a single physical equipment and related automation, we could potentially streamline the workflow, reduce handling steps, and significantly improve overall manufacturing efficiency.” From Concept to THESYS® Integration The idea of combining reaction-based and membrane-based processes might seem complex, but Bhatt emphasized that the separation of these steps is largely historical, not technical. “Cleavage and deprotection are reaction steps… whereas TFF is a membrane separation process,” he said. “Though there are different mechanisms involved, they can operate on the same product stream and can share the same fluid handling architecture if designed properly.” Within the THESYS® platform, this integration is enabled through automation and system design that bring multiple unit operations into a single, cohesive workflow. Advances such as closed-loop temperature control, precise dosing, and real-time pressure monitoring allow both reaction and filtration steps to be managed within one system boundary. Equally important was designing the platform for hazardous environments from the outset. “That eliminated the need for intermediate product transfers, which made this integration approach much more practical.” Engineering for Efficiency and Scale One of the most significant engineering challenges was balancing performance with practicality. “Designing the combined system to keep the footprint to a minimum while also taking operability and maintainability into consideration was one of the biggest challenges,” Sagar said. The team also focused on minimizing holdup volume, maximizing product recovery, and ensuring cleanability for GMP operations—all within a compact system design aligned with THESYS®'s broader focus on efficient, scalable manufacturing systems. The result is a platform that delivers efficiency gains primarily by eliminating transfers. “In traditional setups, the material moves between different systems and sometimes even between different rooms,” he explained. “Each transfer adds time, manual handling, and potential product loss.” By consolidating operations into a single THESYS-based system, manufacturers can complete processes sequentially without interruption, reducing both time and risk. Improvements in Safety and Process Control Beyond efficiency, integration significantly enhances safety and control. “Operators no longer need to move material between systems in solvent handling environments,” Sagar said. “Keeping everything inside one enclosed physical system significantly reduces exposure risk and handling errors.” From a control standpoint, a unified automation framework governs all stages of the process. “The same system carefully controls dosing and temperature during the reaction phase and also controls pressure and flow during filtration,” he noted. “The unified control improves reproducibility and helps contain the process within validated operating conditions.” Footprint and Operational Savings The benefits extend to facility design as well. “Instead of installing separate systems with their own vessels, pumps, and control panels, manufacturers operate one integrated system,” Sagar said. “This can free up valuable clean room space and reduce infrastructure requirements.” Fewer systems also mean fewer cleaning cycles, fewer validations, and less maintenance, resulting in meaningful operational savings over time. Designing for Flexibility: A “Built for You” Approach A defining characteristic of the THESYS® platform is its flexibility. The system is designed to align with each customer's process rather than enforce a rigid standard. “The system is designed to adapt to each customer's manufacturing process rather than forcing the customers to adapt their processes to the equipment,” Sagar explained. For example, the system can accommodate different filtration control strategies. “Some customers perform filtration using transmembrane pressure… while others use permeate flow. The system has the capability to operate on both.” Customer feedback also shaped physical design elements, including vessel sizing, filter configurations, and facility integration. “These kinds of small but critical considerations help the system fit naturally into the customer's manufacturing environment without major disruptions.” Validation, Compliance, and Integration Integration also simplifies GMP validation. “When you combine multiple operations into a single system, you reduce the number of vessels, process flow paths, and connection points,” Bhatt said. “That means fewer product contact surfaces to clean and validate.” The system uses hygienic design principles and recipe-driven automated cleaning cycles, with electronic batch records supporting compliance. Importantly, the THESYS®-based system integrates easily into existing manufacturing lines. “The upstream synthesis process does not change,” Sagar noted. “After synthesis, the product simply enters this integrated platform.” Because the system is designed for hazardous environments, it can be installed directly where cleavage and deprotection already occur, eliminating the need for downstream relocation. Industry Recognition and Future Impact The system's impact has already been recognized with an Interphex Innovation Award, which Sagar described as “a strong validation from the industry.” “The award recognized that integrating these steps… addresses real challenges that manufacturers face, like complex workflows and inefficient equipment setups.” Looking ahead, he sees integration—central to platforms like THESYS®—becoming a core design principle in oligonucleotide manufacturing. “As demand for DNA and RNA therapeutics continues to grow, manufacturers will need equipment that supports higher throughput, consistent product quality, and faster batch turnaround.” Integrated, modular platforms will play a key role in meeting these demands. “Over time, we are likely to see more compact automated systems performing multiple process steps… helping facilities scale production more efficiently and accelerate the development of new therapies.” A Shift Toward Smarter Manufacturing The integration of cleavage, deprotection, and TFF within platforms like THESYS® represents more than just a technical advancement, it signals a broader shift toward streamlined, automated, and modular biomanufacturing. By reducing complexity, improving safety, and enabling scalability, integrated systems are poised to redefine how oligonucleotides are produced, bringing the industry closer to faster, more efficient delivery of next-generation therapeutics. To learn more, please see Optimize Your Oligo Manufacturing

In this episode of Let's Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read it and what matters in practice.Covers: • Scope and where GMP begins • API starting material (core concept) • GMP scaling across the process (Table 1) • Quality unit and QMS expectations • Production and in-process controls • Validation and change control • CMOs and supply chain • Clinical trial flexibility (Section 19)Timestamps00:00 Intro00:13 What Q7 Covers01:23 Scope and GMP Start02:19 API Starting Material04:05 GMP Scaling (Table 1)05:30 Quality and QMS06:58 Production Controls08:26 Validation09:46 Change Control10:27 CMOs / Supply Chain12:11 Clinical13:12 Takeawayshttps://database.ich.org/sites/default/files/Q7%20Guideline.pdfSubhi Saadeh is the Founder and Principal at Let's ComBinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.

Arctic fish survive in waters that would freeze most life solid. Not because they tolerate ice, but because their biology prevents crystals from forming in the first place. That same principle, translated into synthetic peptide chemistry, is now showing performance data that DMSO cannot match. Part 2 is where the science becomes practical.Steve Oh spent 22 years at Singapore's A*STAR accumulating 43 patents across stem cell bioprocessing, microcarrier technologies, and serum-free media. He now advises XTherma, where he has been stress-testing their DMSO-free cryopreservation solution across T cells, MSCs, organoids, and beyond. In Part 2, he brings the data.Key topics discussed:How antifreeze protein-inspired peptide chemistry reduces ice crystal size and protects cells during freezing and thawing (00:23)T cell and MSC performance data comparing XT Thrive to DMSO and CryoStor CS10, including a 2.5-fold increase in cell yield on microcarriers post-thaw (02:23-05:00)Why ice crystal formation causes more damage during thawing than freezing, and how XT Thrive addresses this (05:32)Elimination of the post-thaw wash step and what that means for contamination risk and manufacturing simplicity (07:00)Hold time extended to 24 hours and storage performance across 4°C, -80°C, and -196°C (08:01)Applicability beyond single cells: organoids, islets, and potential implications for organ preservation (09:50)How to transition from DMSO to XT Thrive: GMP grade, Drug Master File, same concentration, no protocol overhaul required (10:49)Broader cell therapy challenges: differentiation time, cell population consistency, and cost of goods (12:03)Smart insight:The transition away from DMSO is more accessible than most scientists assume. XT Thrive is GMP-grade, carries a Drug Master File, and is used at the same 5-10% concentration as DMSO, making it a plug-and-play substitution for most cell types. The manufacturing implications go further: no wash step, extended hold times, and storage stability across all standard temperature ranges simplify both production workflows and cold-chain logistics to remote treatment sites.If you're interested in this topic, check out these episodes, where we explore how Minnesota's frozen forests inspired a new wave of biotech innovation, transforming how life-saving cells are frozen, stored, and shipped.Episodes 161 - 162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey AllenThis is Steve's second appearance on the podcast. You can also catch his earlier conversation with David, where they explored the challenges and opportunities of cell and gene therapy.Episodes 11 - 12: From Lab to Patient: Steve Oh's Guide to Mastering Cell Therapy Process Development.Connect with Steve Oh:Email: skwohso@gmail.comLinkedIn: www.linkedin.com/in/steve-oh-4946261/Support the show

A busy feelgood Friday on the GMP! today with guest slots featuring the welcome return of Savvy Cat Ana Caramujo fresh from Brazil, Coach Turner ahead of his upcoming Portugal trip, and new GuMPer Mario De Oliveira (creator of GuMPy!) with his ideas on how AI can help (and NOT terrify) you in your daily life...Become a supporter of this podcast: https://www.spreaker.com/podcast/the-good-morning-portugal-podcast-with-carl-munson--2903992/support.Join Carl on screen - book your slot on the show at www.goodmorningportugal.com

Herbal Medicine, Quality Control, and Adulteration Prevention: Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), recounts his entry into herbalism via vegetarianism in 1968, off-grid living, and starting a wholesale herb business in 1974 before shifting to nonprofit education, research, advocacy, and quality control. The discussion covers the evolution from teas and tinctures to standardized extracts, the complexity and synergy of multiple constituents, and how standardization supports quality control and therapeutic consistency. Blumenthal explains ABC's Botanical Adulterants Prevention Program and its free, peer-reviewed resources addressing global fraud, plus GMP requirements and laboratory methods for identity, contamination, and potency testing. He discusses herbs including ashwagandha, turmeric/curcumin and adulteration risks, maca, nigella, and milk thistle, and outlines ABC resources, HerbClip, and membership options at herbalgram.org.

Our pals in Ponte De Lima check in and chat, with an update on their dog loving duties!Let's get the week off to a fun and informative start.Add your input here - https://www.skool.com/gmp-vips-1236/captain-carls-log-06-03-26Book your slot on The GMP! here - https://calendly.com/carlmunson - and share your self, product orservice with the GuMPers (-:Become a supporter of this podcast: https://www.spreaker.com/podcast/the-good-morning-portugal-podcast-with-carl-munson--2903992/support."The one you're thinking of is Good Morning Portugal! hosted by Carl Munson. It's an English-language live show/podcast aimed at expats (especially 50+ folks) settling into or loving life in Portugal. It's streamed live on YouTube weekdays around 8-9 AM (often with a cheerful Olá Bom Dia ALEGRIA! vibe), covering news, weather, culture, wellbeing, property tips, moving advice, and fun chats. Carl helps people buy, rent, or scout homes—contact him at +351 913 590 303 or carl@carlmunson.com if you need that. You can catch full episodes on YouTube (channel: Good Morning Portugal!), as a podcast on Spotify/Apple, and join the free Portugal Club community at theportugalclub.com for more support and connection. It's super positive, community-focused, and still going strong in 2026!" - Grok

On this Kaya Cast episode, host Tommy Truong sits down with Dr. Bonni Goldstein of Goldstein Wellness to unpack the science, medicine, and business of cannabis in epilepsy and beyond. Dr. Goldstein is the Chief Medical Advisor for Neurotech International, helping to develop effective cannabinoid-based formulations for autism and other pediatric neurologic conditions.From the endocannabinoid system to multimodal cannabinoids like CBD, CBDV, CBG and CBDA, they discuss how clinicians tailor regimens for pediatric and adult patients, why dosing is start low and go slow, and what the latest clinical data show about seizure reduction and quality of life. Bonni shares her journey from pediatric emergency medicine to medical cannabis, the Charlotte story that helped launch CBD in epilepsy, and practical dosing, safety, and drug interaction considerations. They also talk about the business side: educating clinicians, ensuring product quality, and Goldstein Wellness's free clinician education program with about 50 videos, plus a patient-facing network of vetted cannabis clinicians. If you're a dispensary executive, grower, or clinician, this episode offers actionable insights on education, regulation, and patient-centered cannabis care. Find out more about Goldstein Wellness at:https://goldsteinwellness.com/https://www.linkedin.com/in/bonnigoldsteinmd/https://www.linkedin.com/company/goldstein-wellness/ 00:00 CBD Seizure Success00:17 Meet Dr Bonni00:58 From ER to Cannabis02:00 Cancer Patient Turning Point04:30 ECS Explained Simply08:16 Receptors and Evolution11:44 Dysfunction and Conditions13:40 Research Barriers and COVID16:42 CBD for Intractable Epilepsy19:51 Charlotte Figi Breakthrough24:13 How CBD Calms Seizures26:47 Dosing and Other Cannabinoids29:54 Beyond Seizure Control31:08 Medical vs Recreational Divide31:50 Medical vs Adult Use32:39 Teaching Cannabis Literacy34:26 Beyond CBD and THC34:53 CBG Effects and Dosing38:53 CBG Biomarkers Research41:16 CBN and Sleep Evidence43:32 CBDA Raw Anti Inflammatory46:55 CBDA vs CBD Decisions50:41 Future Biomarker Guided Care52:23 THCV Metabolism and Caution57:06 Synthetic Cannabinoid Risks01:00:03 Wrap Up and Resourcesmedical cannabis, cannabis for epilepsy, CBD for seizures, CBDV research, CBG benefits, CBDA cannabinoids, endocannabinoid system explained, pediatric epilepsy treatment, adult epilepsy cannabis, seizure reduction data, cannabinoid dosing guidelines, start low go slow cannabis, cannabis drug interactions, CBD drug safety, medical cannabis for autism, pediatric neurologic conditions, cannabinoid formulations, evidence based cannabis medicine, clinical data cannabis epilepsy, quality of life seizure patients, Dr Bonni Goldstein, Goldstein Wellness, Neurotech International, cannabinoid clinical trials, CBD epilepsy Charlotte story, Epidiolex discussion, cannabis and seizure disorders, neurologist cannabis education, clinician cannabis training, cannabis CME education, vetted cannabis clinicians network, patient centered cannabis care, cannabis compliance and regulation, dispensary education strategy, cannabis product quality standards, GMP cannabis manufacturing, lab tested cannabinoids, full spectrum vs isolate CBD, multimodal cannabinoids, entourage effect science, cannabis pharmacology, cannabis titration strategy, pediatric dosing cannabis, cannabis safety in children, cannabis and antiepileptic drugs, clobazam CBD interaction, valproate CBD interaction, liver enzyme monitoring cannabis, seizure frequency reduction, refractory epilepsy cannabis, Lennox Gastaut syndrome CBD, Dravet syndrome CBD, autism spectrum disorder cannabis research, neuroinflammation and cannabinoids, CB1 and CB2 receptors, endocannabinoid deficiency theory, cannabis telemedicine clinicians, state medical marijuana laws, Schedule III cannabis implications, dispensary operator insights #kayacast #cannabis #tips #dispensaries #business #podcast

For years, mammalian cells and microbial systems have dominated the biotech landscape, shaping the economics and access to life-saving biologics. Yet, in countries where capital and infrastructure are limited, those gold-standard systems bring hefty price tags and daunting complexity. The answer isn't bigger bioreactors; it's alternative biomanufacturing approaches, such as molecular farming. Imagine medicines grown like crops, ready for harvest in days, not months.Meet Waranyoo Phoolcharoen, Co-Founder and CTO of Baiya Phytopharm and Professor at Chulalongkorn University in Bangkok, a scientist who didn't settle for the status quo. As the driving force behind the company, she led the charge to cut through process bottlenecks: navigating regulatory hurdles, scaling plant-based vaccine manufacturing to 5 million doses per month, and reshaping the approach to antibody production for oncology and infectious diseases. Her work proved that plants aren't an alternative. They're a platform.Topics discussed include:How plant-based molecular farming compares to traditional microbial and mammalian cell systems (02:44)The flexibility and rapid scalability of using plants for biomanufacturing (05:06)Speeding up process development with transient expression versus transgenic plants (05:45)Regulatory perspectives and the approval process for plant-produced biologics (06:52)An overview of the ongoing oncology and infectious disease antibody pipeline (08:08)Strategic challenges: balancing product development, revenue, and market-ready innovations through subsidiary companies (09:51)Lessons learned from building a GMP facility capable of 5 million doses per month during the pandemic, with supply chain as the biggest bottleneck (12:50)Future innovations in molecular farming and the role of plant platforms in medicine production (14:47)Smart insight:Platform choice matters. If you're struggling with long development timelines or scale-up challenges, it may not always be the molecule. It may be the system you're using. Molecular farming offers a different set of trade-offs: faster development, flexible scaling, and a practical alternative worth considering before defaulting to a single platform.If you're interested in other unconventional biological platforms reshaping biomanufacturing, don't miss these episodes exploring emerging production technologies:Episodes 141 - 142: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel BardorEpisodes 163 - 164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas SchaafEpisodes 229 - 230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim CorcoranConnect with Waranyoo Phoolcharoen:Email: Waranyoo.P@baiyaphytopharm.comBaiya Phytopharm website: www.baiyaphytopharm.comNext step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

In this highly educational episode of Beauty Bytes, I sit down with Dr. Jason Pencek, a chiropractor and nurse practitioner who is highly trained in IV therapies and peptide protocols. We are tackling the "Wild West" of the current wellness space. With everyone from Pilates instructors to airline stewardesses suddenly selling peptides on social media, we break down exactly why you cannot afford to crowdsource your medical advice. We take a deep dive into the massive safety risks of buying "research grade" peptides online to save a few bucks, explaining how dangerous endotoxins and poor manufacturing can land you in the hospital. Jason outlines exactly what you need to look for in a legitimate 503A or 503B compounding pharmacy, including FDA registration and GMP certification. We also explore the nuances of hormone optimization. Jason explains why he prefers using Growth Hormone Secretagogues (like Tesamorelin and CJC-1295) to wake up your body's dormant cells, rather than shutting down your natural production with straight human growth hormone. Plus, we cover the most effective ways to administer NAD+ without sitting through a four-hour IV drip, and why checking your methylation and homocysteine levels first is an absolute must.

What if a drug could kill cancer cells broadly, spare the immune system and then train it to keep fighting, without triggering resistance? That's the promise behind the ELANE pathway, a mechanism discovered not from a hypothesis but from studying fundamental biology in patients. In this episode of the In Vivo Podcast, Court Turner, CEO and co-founder of Onchilles Pharma, and Lev Becker, CSO and scientific founder, discuss how a neutrophil elastase-based mechanism is being translated into N17350, a first-in-class intratumoral agent targeting solid tumours including head and neck, skin and breast cancers. With $40m raised, GMP manufacturing of thousands of clinical doses completed, a US IND approved, and a first-in-human study underway in Australia, Onchilles is moving from "stubborn optimism" to clinical execution. Court and Lev discuss the dual mechanism that sets N17350 apart from both traditional chemotherapy and immunotherapy, why histone H1 functions as a universal tumour vulnerability rather than a conventional biomarker, and how they're thinking about combinations, partnering and the eventual value story for payers.

How solid is your CMC foundation—and what happens if it cracks under pressure?David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs.His “house building” approach demystifies CMC's complexity, showing why early diligence paired with regulatory fluency and scientific insight pays dividends for years.Tune in to hear Henri's practical wisdom distilled through real-world analogies:Building a strong CMC foundation in early phases and why later fixes can be costly or impossible (02:45)Scaling up: supplying Phase 3 with the final commercial process, including robustness and supply chain strategies such as dual sourcing critical raw materials (03:23)Process validation explained: FDA's three stages, from control strategy justification to continued verification (05:15)Process Performance Qualification (PPQ): what it is, how many batches are needed, and optimizing timing (07:43)Handling lifecycle changes: maintaining process control, adapting to deviations, and improving systems after regulatory approval (09:34)Managing teams, stakeholders, and cross-functional collaboration in CMC programs (11:49)Importance of good project management, access to scientific expertise, and interpreting guidelines for your specific program (12:27)The “half scientist, half lawyer” analogy for mastering both technical and regulatory aspects (15:08)Smart insight:Never underestimate CMC. If you do, you will pay for it later.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later.Henri Kornmann has spent two decades making those decisions the right way. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has crossed between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His conclusion: a CMC program is like building a house. Get the foundation wrong and no amount of late-stage effort will save you.In Part 1, Henri reveals the decisions that cannot be undone and how to get them right from the start.What you will learn:Evolution of cell bank technology and regulatory expectations (00:33)The impact of weak CMC foundations on late-stage failure (00:51)Lessons learned from Ferring's gene therapy approval and CMC gap analysis (06:51)FDA statistics on CMC issues in INDs and response letters (08:07)Critical early decisions: cell bank clonality and proper storage practices (10:22)The importance of comprehensive raw material documentation (12:29)Early analytical characterization and discovering molecular “funkiness” before phase trials (13:41)Supply strategy for phase 2—why stability and batch knowledge matter (14:49)Introduction to critical quality attributes (CQA), process parameters, and quality-by-design principles (15:52)Common pitfalls in CQA identification and continued process verification (17:01)Smart insight:The therapies that reach patients aren't built on heroic late-stage rescues. They're built on disciplined early decisions: the right cell bank, the right analytics, the right documentation. Henri's message is unambiguous: there are CMC mistakes you can fix later, and there are CMC mistakes you cannot. Knowing the difference is the foundation of every successful biologics program.In Part 2, Henri walks through scale-up to commercial manufacturing, process validation stages 1 through 3, post-approval control strategy, and the project management and regulatory fluency that separate successful CMC leaders from the rest.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Episode 2769 - Vinnie Tortorich and Anna Vocino discuss trusting product certifications as well as make some fun announcements. https://vinnietortorich.com/2026/03/trusting-product-certifications-episode-2769 PLEASE SUPPORT OUR SPONSORS Pure Vitamin Club Pure Coffee Club NSNG® Foods VILLA CAPPELLI EAT HAPPY KITCHEN YOU CAN WATCH THIS EPISODE ON YOUTUBE - @FitnessConfidential Podcast Vinnie's workout videos are available to purchase! Choose from a 2-day, 4-day, or 6-day workout–or buy all three at a discount! TO PURCHASE VINNIE'S WORKOUT VIDEOS, CLICK THIS LINK: https://vinnietortorich.com/workout Trusting Product Certifications Anna was just on the Mike Rowe podcast, "The Way I Heard It". (2:00) Vinnie is excited about his guest, D-D Breaux, who is a legendary gymnastics coach. (7:00) D-D's episode has already been posted so that you can enjoy it sooner. You can listen to it here: https://sites.libsyn.com/40024/building-excellence-with-d-d-breaux-episode-2768 Vinnie wants to be back into skiing for the first time in nine years! (13:00) Anna received her Jaspr air scrubber. (22:00) Certification of products—what is that about, and is it real? (32:00) Anna explains how it works, and they discuss olive oil as an example. Compliance and scaling up manufacturing needs are important. Vinnie won't work with a company unless it is GMP- and NSF-certified. GMP is Good Manufacturing Practices. NSF is the National Science Foundation. Supplements can be suspect if they are manufactured in a facility without GMP or NSF practices. Certifications can matter and can also be abused. (48:00) Anna has a fantastic announcement: she is stepping into the shoes of the late Estelle Harris and becoming the voice of Mrs. Potato Head in Toy Story 5! (50:00) They discuss a little of the darker side of being an actor in L.A. (1:00:00) Did you miss it?: The NSNG® VIP group closed, but you can get onto the waitlist for next time by signing up at https://www.nsngvip.com/join. A New Sponsor Jaspr Air Scrubbers has a discount code, VINNIE, that gets you $300 off for a limited time. Jaspr offers a lifetime warranty. Go to Jaspr.co for more information or to purchase. (1:05:00) You can book a consultation with Vinnie to get guidance on your goals. https://vinnietortorich.com/phone-consultation-2/ More News Serena has added some of her clothing suggestions and beauty product suggestions to Vinnie's Amazon Recommended Products link. Self Care, Beauty, and Grooming Products that Actually Work! https://www.amazon.com/shop/vinnietortorich/list/3GPVU29UHHPMY?ref_=aipsflist Don't forget to check out Serena Scott Thomas on Days of Our Lives on the Peacock channel. "Dirty Keto" is available on Amazon! You can purchase or rent it here.https://amzn.to/4d9agj1 Please make sure to watch, rate, and review it! Eat Happy Italian, Anna's next cookbook, is available! You can go to https://eathappyitalian.com You can order it from Vinnie's Book Club. https://amzn.to/3ucIXm Anna's recipes are in her cookbooks, on her website, and on Substack —they will spice up your day! https://annavocino.substack.com/ PURCHASE DIRTY KETO (2024) The documentary launched in August 2024! Order it TODAY! This is Vinnie's fourth documentary in just over five years. Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries Then, please share my fact-based, health-focused documentary series with your friends and family. Additionally, the more views it receives, the better it ranks, so please watch it again with a new friend! REVIEWS: Please submit your REVIEW after you watch my films. Your positive REVIEW does matter! PURCHASE BEYOND IMPOSSIBLE (2022) Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries FAT: A DOCUMENTARY 2 (2021) Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries FAT: A DOCUMENTARY (2019) Visit my new Documentaries HQ to find my films everywhere: https://vinnietortorich.com/documentaries

In the newest episode of "The Weekly Bioanalysis" podcast, our hosts, John and Dom welcome Scott Weir (Director, Institute for Advancing Medical Innovation at KU Medical Center) for a practical, behind-the-scenes look at how drug discovery and development can be executed in an academic setting—and what it takes to translate promising lab or bedside discoveries into real clinical programs. Scott breaks down the process through three clear “pillars” that guide early development: does the drug reach the site of action, engage the target, and produce the intended pharmacologic response—from preclinical studies through early-phase trials. He also explains how KU builds a “virtual biotech” model by combining industry-experienced teams, university core infrastructure, and CRO partners like KCAS Bio, including a discussion of their “triple threat” CAR-T program (CD19/20/22) manufactured on-site in a GMP cellular therapy facility. The conversation goes deeper into the realities of cost, bioanalytical and biomarker needs across modalities, and how public–private partnerships help academic programs cross the “valley of death” from animal proof-of-concept to clinical proof-of-concept.“The Weekly Bioanalysis” is a podcast dedicated to discussing bioanalytical news, tools and services related to the pharmaceutical, biopharmaceutical and biomarker industries. Every month, KCAS Bio will bring you another 60 minutes (or so) of friendly banter between our two finest Senior Scientific Advisors as they chat over coffee and discuss what they've learned about the bioanalytical world the past couple of weeks. “The Weekly Bioanalysis” is brought to you by KCAS Bio.KCAS Bio is a progressive growing contract research organization of well over 250 talented and dedicated individuals with growing operations in Kansas City, Doylestown, PA, and Lyon, France, where we are committed to serving our clients and improving health worldwide. Our experienced scientists provide stand-alone bioanalytical services to the pharmaceutical, biopharmaceutical, animal health and medical device industries.

What if the reason you’re not healing isn’t that you need another diagnosis? 0:08 It’s that your cells aren’t receiving the right signals. Because the body doesn’t run on diagnosis, it runs on 0:16 communication. And peptides are one of the most powerful, most misunderstood 0:21 tools we have for cellular signaling, immune balance, tissue repair, gut 0:27 lining support, metabolic control, brain signaling, sleep cycles, and even sexual 0:35 wellness. Today, I’m going to do what most people won’t. Define peptides in 0:41 plain English for you. break them into categories by what they’re best at and 0:47 tell you which ones are FDA approved on the list and which ones are commonly 0:53 used off label or investigational with the evidence that actually says these 1:00 work. This is going to be a powerful episode and if you’ve ever felt like you’re hearing hype without clarity, 1:07 this one’s for you. So, as usual, grab your cup of coffee or tea and settle in 1:13 as we talk about peptides that can fit into your healing journey. We’re going 1:19 to have a short word from our sponsor. You know, we got to do that. That’s how we stay on the air here. So, we will be 1:26 right back after this. Did you know sweating can literally heal your cells? 1:32I nfrared saunas don’t just relax you. They detox your body, balance hormones, 1:37 and boost mitochondrial energy. I’m obsessed with my health tech sauna. And 1:42 right now, you can save $500 with my code at healthtechalth.com/drmuthqen25. 1:54 All right, here we go, guys. I am excited to dive into peptides with you. 2:00 So understanding peptides is foundational, right? And I’ve been 2:06 studying peptides now for about nine years. Um, and I find that they are 2:13 incredible. Um, so I want to break down for you what peptides actually are, what 2:19 they do, and some of the top peptides that are available today, and how they 2:25 can be utilized. Because I think it’s really important. And I think it’s it’s there’s a lot of confusion out there about what these things actually are and 2:32 are they safe? Are they not? When do we use them? What’s the science behind them? So, we’re going to dive in and 2:38 we’re going to talk about all things peptides. So, let’s get ready here. Here we go. So, peptides are short chains of 2:45 amino acids and they typically range anywhere from 2 to 50 amino acids and 2:51 they’re linked by peptide bonds. So think of them as the superglue that holds the amino acids together. They sit 2:58 between the amino acids and they are full proteins in terms of their size and 3:04 their complex structure. And what makes peptides particularly interesting in 3:10 medicine is their role as signaling molecules. They’re essentially the 3:15 body’s text messages carrying specific instructions to cells and tissues. And 3:21 unlike our proteins which often serve as structural roles or act as enzymes, 3:28 peptides typically function as hormones, neurotransmitters and growth factors and 3:33 they bind to specific receptors on the cell’s surfaces or within the cells and 3:39 they trigger this effect. It’s like a cascade effect of a biochemical reaction 3:45 that ultimately changes the cellular behavior. So basically, it’s changing 3:50 the way the body’s cell structure acts. And this is why peptides can be so 3:56 incredibly powerful and therapeutic when you introduce the right peptide signal. 4:02 Now, you could theoretically redirect cellular processes toward healing, 4:07 towards metabolism, immune balance, tissue repair. Any of those things can 4:14 be manipulated to do a certain thing once we add the peptide. The challenge 4:19 in peptide medicine though lies in distinguishing between those peptides that have been rigorously studied, 4:26 proven safe and effective and approved by regulatory bodies like the FDA versus 4:31 those that exist in what we call the gray zone of a promising clinical data. 4:36 But they really lack human validation so far. And this distinction is critical because the presence of a plausible 4:43 mechanism does not guarantee safety or efficacy in living humans. So, this is 4:50 really important and we’re going to dive in and look at some of the research on all of these different peptides that are 4:56 available and I’m excited to say there’s some amazing peptides being studied right now that unfortunately are not 5:01 available. But I can’t wait to see them hit the market for us because it is going to be a gamecher as far as health 5:09 and longevity. So there is a quality control issue and there is a hidden 5:14 variable in peptide medicine with this and it’s one of the most underappreciated aspects of peptide 5:21 therapy particularly for non-FDA approved peptides. It’s quality control. 5:26 When we discuss pharmaceutical medicines, we take for granted that the pill contains what the label says. Not 5:32 always true depending on where it comes from. You guys, if you’ve heard my episodes before talk about how many of our medications are made in China and 5:41 have been contaminated with other things, you will realize that that is not always true. So, just because it has 5:48 the FDA stamp of approval on the medication, it still does not necessarily mean it’s safe and we still 5:54 need to do our homework on it. So, sorry for digressing on you guys, but you know, when we get a medication, we we 6:00 think that what the amount says is what is there, doesn’t have contaminants, it’s manufactured with good 6:06 manufacturing practices. You’ll see that listed as GMP on the bottle, and it’s been stored properly, it’s been 6:12 maintained stable, and with research peptides and compounded formulations, 6:17 none of this can be assumed. So, I will share a story with you. There was a gentleman that was purchasing these 6:24 peptides online from a research facility and um did not know that they were 6:30 coming from China and he was ordering a particular growth hormone peptide and 6:35 after a little while he had he had done fine for the few first few bottles. After a little while he started having 6:42 some complications. He started getting really irritable and angry and ragy and 6:47 he didn’t quite know what was going on. And so he decided to go get some testing done. He had some blood testing done and 6:53 his testosterone level was over 5,000. So for those of you who know what testosterone level should be for a guy, 7:00 they really shouldn’t be any higher than about 1,00200 would be absolute max that we’d want to see. Now he was taking 7:06 testosterone but not to that degree. And prior to adding this peptide, his 7:12 testosterone was very stable. What they ended up finding out was the peptide that he was getting, whoever was 7:18 manufacturing it added testosterone to the peptide. They felt like if if it had growth hormone, that was great, but if 7:25 it had growth hormone and tes testosterone, all the better. And he didn’t know that. And this is the 7:31 problem that we can have with peptides if you don’t source them properly. if you’re not working with somebody that 7:37 knows how to source them and can prove that they are what they say they are. Um, I’m sure there’s a whole bunch of 7:42 studies out there too of people getting these peptides and paying hundreds of thousands of dollars for them over their 7:48 lifetime and finding out they were nothing more than just sterile water. So, you really do need to be careful 7:53 with your quality control. Now, this kind of leads us right into the next topic that we’re going to talk about and that’s the manufacturing question, 8:00 right? The FDA approved peptides are manufactured in facilities subject to 8:05 the FDA inspection rules following our GMP regulations and these facilities 8:11 must validate their manufacturing process, demonstrate consistency batch to batch, test for purity and potency. 8:18 They need to test for bacterial endotoxins and sterility and they need to maintain detailed records. So, when a 8:25 pharmaceutical company submits a drug application, the FDA inspects the manufacturing facility as part of the 8:32 approval process. If you’re getting peptides from a different country, none of that is happening. And there are some 8:38 ways for us to determine if that is what you’re getting. Typically, the rule of thumb is if your peptides are coming 8:44 with a different colored top, every one of them has a different colored top. Those are typically being sourced out of 8:49 China. I wouldn’t say that’s 100% but that’s kind of the rule of thumb that people follow. So compoundingies these 8:56 are thearmacies that make our bio identical hormones. They can make medications in any dose or strength or 9:02 route. There are thousands of them in every not that not in every state but 9:08 there are thousands of them around the country right now. So these compoundingies are registered as 503A 9:15 facilities. They do traditional compounding for individual prescriptions, right? Like they can make 9:20 thyroid, they can make LDN, they can make estrogen. You can also have a 503b 9:27 facility, which is an outsourcing facility. And these companies produce larger batches of products. They’re they 9:34 have some oversight, but they’re less stringent than for FDA approved 9:40 manufacturers. And state boards of pharmacy regulate a 503A pharmacy. And 9:45 the FDA can inspect the 503b facility, but doesn’t preapprove any of their 9:52 compounding products. So, they can inspect it, but they don’t approve them. So, research chemicals and these 9:58 suppliers operate essentially with no oversight. They explicitly market products for research use only, not for 10:06 human consumption to avoid FDA regulation. If they put that on their 10:12 product, they don’t have to comply to what the FDA is saying. And there is no required manufacturing strategies or 10:19 standards, no required testing, no required sterility assurance, and no enforcement mechanisms if products are 10:26 mislabeled or contaminated. So basically, they don’t have the liability, but that doesn’t mean that 10:31 all of them are badies or bad suppliers. It just means they don’t have to comply 10:37 to the FDA rules. Now, there are many of these companies that I’ve seen and I’ve talked to that do do a lot of this. They 10:44 do test their product for sterility. They do test their product to make sure it is what it says it is. They don’t 10:51 have to, but they do. So, if you’re going to decide to use a company that 10:56 has research only, not for human consumption, at least ask for their 11:02 proof of testing so that you know that the product you’re getting is what it says it is and that it’s clean. Because 11:08 this is where we run into the problem is in purity. So in purity peptide 11:13 synthesis can produce not just the targeted peptide but also related 11:19 peptides with deletions, substitutions, truncations or truncations of amino 11:25 acids. Sorry. And this high performance liquid we call it uh chromatography can 11:30 separate these related impurities and quality and quantify the actual target 11:35 of the peptide content. So a certificate of analysis is what you want to ask these companies for. This shows the HPLC 11:44 the testing mechanism with greater than 95% or ideally 98% purity which 11:51 indicates a higher quality product. So this certificate of analysis can be fabricated may not represent the 11:57 specific batch being sold. It happens. We need to know not everybody is honest. Not everybody, you know, does what they 12:03 say and it does what’s right. But at least you at least they’re giving you something and you have some security. 12:10 and then choose a company that was referred to by someone else that has done some homework as well. In in 12:16 commercial research, there’s independent testing and they research peptides and this has been really shocking 12:23 variability that they’ve seen. Some products contain 50% or less of the 12:29 claimed peptide and some contained primarily degradation of the product or manufacturing impurities and some 12:36 contained bacterial endotoxins at levels that could cause fever and systemic 12:42 inflammation if it was truly injected. And I would also worry with some of those problems, you know, depending on 12:48 what impurity or bacterial endotoxin was there. If you’re using a product to boost your immune system and your immune 12:54 system is already compromised, these bacterial endotoxins can actually make you sicker instead of what you want it 13:02 to do, which is making you better. So, sterility is always an issue with anything that is manufactured, 13:08 especially things that we’re doing as an injection. Peptides are intended for injection. They must be sterile. They 13:16 must be kept safe. And pharmaceutical manufacturers conduct this sterility testing on every batch. 13:22 Compoundingarmacies should conduct sterility testing particularly for high-risisk compounded 13:28 sterile preparations and research chemical suppliers may or may not conduct any testing. So injecting 13:35 non-sterile material can cause local infections, abscesses at the injection 13:41 site and or if the bacteria enters the bloodstream could potentially be 13:46 life-threatening and you could have sepsis. Now, excuse me. We saw this 13:52 happen in a compounding pharmacy uh gosh, it’s probably been 10 years ago 13:57 now, I think. um they unfortunately had a strep uh contamination in their 14:03 product and they weren’t testing it. It was a large compounding pharmacy out of Florida and they were making products 14:08 that were being injected into the joints and um these people got very very sick 14:14 and some of them died and um some of them got very very injured by this uh 14:21 complication that happened. So it’s not like this doesn’t happen. It does, but it doesn’t happen often. And that’s what 14:28 we have to know about. And so, when we’re talking with you guys about storage and stability, it’s really 14:34 important to make sure you maintain your peptides well. So, many peptides are unstable at room temperature. They 14:41 require refrigeration or freezing. We tell everyone to make sure you’re refrigerating your peptides. That way, 14:48 there’s no question about it. when it stays cold um it prevents or slows down 14:54 the process of uh bacteria growing in it. So some of these peptides actually 14:59 degrade very rapidly in the solution and they must be reconstituted immediately before use and reconstitution of the 15:07 peptides really has limited stability often just days to weeks not months. So 15:13 improper storage, temperature, um changes during shipping or prolonged 15:19 storage of a reconstituted product can lead to degradation into inactivity or 15:25 potentially even a harmful breakdown of the product itself. So if you have a product that’s been sitting in your 15:30 refrigerator for a month or two months or 3 months or 6 months, just throw it away. It’s not going to be any good. 15:37 you’re not going to actually get the peptide and the uh potency that you’re looking for anyway out of it and the 15:44 potential of you introducing an endotoxin, a bacterial endotoxin is quite high at that point. So you just 15:50 really don’t want to take the risk, excuse me. So what practitioners, what 15:56 should we do and what should patients do? Well, for any peptide therapy, we 16:03 want to source our verification. know where the peptide product comes from. Is 16:08 it an FDA approved product? Is it a 503b compounding? A research chemical 16:14 supplier? Is there a certificate of analysis? Request and review this COA. 16:20 And you want it to show purity greater than 95% but ideally greater than 98%. 16:27 You want that identity be identity to be confirmed by mass spectromedy. Uh 16:33 sterility testing should be done. Bacterial endotoxin testing should be done. Batch number matching of the 16:39 product that you received should be done. Proper storage. You want to know that this has been refrigerated or 16:46 frozen as directed once it’s been mixed. Look at the expiration dates for reconstituting your peptides. Track that 16:53 reconstitution date and discarded accordingly like we just talked about. Monitor for your adverse effects. Even 17:01 with the perfect quality control, monitoring for adverse effects is essential with questionable quality and 17:08 vigilance is really critical here. I know it’s frustrating for a lot of patients when they have to get several 17:15 bottles and they only last a week or two. right here, you guys. This is why 17:21 they only last a short period of time because once they’re mixed, they start 17:26 to degrade and they won’t be good and you won’t get the benefit from it. So, 17:31 it’s really important with these research peptides specifically, practitioners should recognize that all 17:38 recommending products without quality assurance violates the fundamental medical principle of first do no harm. 17:45 If a patient is determined to use research peptides despite counseling, providing guidance on quality 17:52 verification, requesting those COAs, using pharmaceutical grade sources when available, proper testing, this all 17:59 reduces harm, but doesn’t constitute necessarily that recommendation. Now, 18:06 that being said, today it’s very difficult to find peptides by the compoundingies because of what the FDA 18:13 has done. So most of the peptides that are available to us have been labeled 18:18 not for human consumption, not because they’re not good products, but because 18:25 of what the FDA did. And this is how these companies have been able to 18:31 continue to provide peptides to the medical community. And if you know you 18:36 have a good company, then you’re, you know, you’re still taking the risk, right? But at the end of the day, the 18:42 reason they’re doing that is to protect themselves from the FDA, from liability. Um, so just kind of know that there is 18:50 some talk in the community with um Bobby Kennedy that this is going to change and 18:55 they are going to bring peptides back to the compounding pharmacies. Now, we don’t know which ones they’re going to 19:01 bring back. Uh, will it be all of them? Will it just be some of them? What’s going to happen here? Um, is it going to 19:07 go to the pharmaceutical companies like our GLP1s did? We don’t know what that’s going to look like quite yet. Um, but it 19:14 is coming and that is positive news. So, let’s talk now about FDA approved 19:21 peptide medications. So, this is the metabolic revolution, right? GLP1 19:28 and our dual increeting agonists. This is an exciting time. GLP-1s are amazing. 19:35 Um, a lot of people are skeptical, a lot of people love them, a lot of people hate them. Whichever side of the fence 19:42 that you’re on, I understand. But I want to talk about the science of it today 19:48 and what it actually means for people. So, the story of GLP1 glucagon like 19:54 peptide one represents one of the most significant advances in metabolic 19:59 medicine in the past several decades. GLP-1 is an accretin hormone. It’s 20:05 gutder derived peptide that potentiates insulin secretion in response to food 20:11 intake. And the body naturally produces GLP-1 in the intestinal L cells, but it 20:17 rapidly degraded by the enzyme DPP4 giving it a halflife of only about 2 20:24 minutes. So this rapid breakdown made in therapeutically impractical until 20:31 research was developed and modified the analoges that resist the enzyme degradation. So for those people who 20:39 never feel full when they’re eating, never feel satisfied when they’re done, this is because their body is either not 20:46 producing enough GLP1 or it’s not getting the signal right. And this is a 20:51 leptin issue. This is an insulin issue. It’s a GLP-1 issue. It’s a complicated 20:56 issue. This is not anything that the person is doing wrong. It’s what is happening to their body. And so GLP1s 21:03 have really revolutionized this. So one particular GLP-1 that we have is 21:09 semiglutide. And this GLP-1 agonist is what changed everything in the world of 21:16 metabolic medicine. Semiglutide is marketed as ompic for type 2 diabetes 21:23 and it’s marketed as WGOI for chronic weight management. It is a modified 21:29 GLP-1 analog with 95 or sorry 94% amino acid sequence uh homology to human 21:37 GLP-1. So it means that it’s it’s just like our own GLP-1 that we make. This 21:42 modification includes specific amino acid substitutions and the addition of C18 21:50 a fatty acid chain which allows the peptide to bind to albumin. Now this 21:56 albumin binding dramatically extends the half-life to approximately one week 22:01 enabling one weekly dosing which is a major advantage over the earlier GLP-1 22:07 agonists that require daily or twice daily injections. The mechanism by which 22:13 semiglutide works is multiaceted. At the pancreatin level, it binds to GLP-1 22:20 receptors on the pancreatic beta cells enhancing glucose depending sorry 22:27 enhancing glucose dependent insulin secretion. This glucose dependency is 22:33 crucial. It means the peptide only stimulates insulin release when blood glucose is elevated. This dramatically 22:41 reduces the hypoglycemic risk compared to insulin or even uh sulfuras. 22:47 Simultaneously semiglutide suppresses glucagon secretion from pancreatic alpha 22:53 cells further improving glycemic control. This is really amazing because 23:00 over the years when we’ve used insulin, which is also a peptide by the way, you 23:05 had to dose it just right because if you didn’t, you would produce so much insulin that it would crash the blood 23:12 sugar and then somebody would have too low of a blood sugar. They’d be hypoglycemic and they’d have to eat more 23:18 sugar and then they’d have to modify the insulin again and the person would be going up and down, up and down, up and 23:24 down all day long. And that created a lot of problems for people and so this 23:30 helps to stabilize that so it is not such an intense change. Now in the GI 23:36 tract semiglutide delays the gastric emptying particularly pronounced during 23:41 the initial weeks of therapy. This slowing of the gastric emptying contributes to the sensation of being 23:48 full and early satiety that patients often describe. However, this effect 23:54 tends to attend to weight over time as the body adapts through the appetite 24:00 suppressing effects generally persist through central mechanisms. So, when we 24:05 talk about what is actually happening, we’re slowing that digestive process down. That’s why people aren’t so 24:11 hungry. It’s why they’re not eating so much. This is why people can develop constipation with these products because 24:17 it’s slowing the body’s digestive tract down. Now some people will call this 24:22 gastroparesis. Um gastroparesis is actually different. 24:28 It is when we lose control over what’s happening in the in the colon like the 24:34 nerves and things like that just stop working. I have never seen that with the GLP1s that we prescribe in micro doing. 24:42 um it’s been documented. It can happen, but again it a lot of it is dosing and a 24:48 lot of it is staying on top of your client and what’s happening and what’s going on and what you’re doing and making sure that they do have good 24:54 motility still. So a lot of these things can be mitigated if you have problems 24:59 with them. Now one of the most profound effects of semiglutide occur in the 25:05 central nervous system. GLP-1 receptors are widely distributed in the brain 25:10 particularly in the hypothalamus and the brain stem area where we are involved in 25:15 appetite regulation. So when when wilding and colleagues published their 25:20 landmark step one trial in the New England Journal of Medicine in 2021, 25:25 they demonstrated that participants receiving 2.4 4 milligrams of semiglutide weekly achieved an average 25:32 weight loss of 14.9% of their body weight over 68 weeks. Now, I want you 25:39 guys to really understand this. We’re talking roughly 15% body weight loss 25:45 over a year, longer than a year. 52 weeks is a year, right? This is 68 25:50 weeks. So, it took longer for them to lose. We’re not talking about giving 25:55 somebody a dose to lose 15% of their body mass in a month or two. That that 26:01 is not healthy for any of us. That is not what we’re talking about doing here. Now, they compared this to placebo and 26:08 the placebo was only 2.4%. So, that is a significant difference. 26:14 And even beyond the numbers, patients reported something very qualitatively different, a reduction in what’s now 26:21 called food noise. Everybody knows what food noise is. We’ve talked about this long before GLP1. It’s that craving. 26:28 It’s that part of your brain that just keeps thinking about I want to eat something. You know, that was actually 26:34 reduced and they didn’t expect to see that happen. Now, this refers to the constant mental preoccupation with food, 26:42 the intrusive thoughts about eating, the difficulty in feeling satisfied. Semi-glutide appears to appears to 26:49 modulate reward pathways in the misolyic system reducing hedonic eating and food 26:57 cravings. Now there are also great cardiovascular effects of semiglutide 27:02 that extend beyond weight loss. Uh the sustained six and select trials 27:07 demonstrated significant reductions in major adverse cardiovascular events uh 27:14 mace in high-risisk populations. The select trial published in 2023 showed 27:20 that semiglutide reduced cardiovascular death, non-fatal myioardial inffection 27:25 and non-fatal stroke by 20% in adults with overweight or obesity and 27:31 established cardiovascular disease but without diabetes. So this suggests that 27:37 mechanisms beyond glucose control and weight loss possibly including 27:42 anti-inflammatory effects, improvements in endothelial function and favorable 27:47 changes to lipid profiles. Now I will tell you the clients that I work with that are on GLP1, 27:53 they will tell you that their inflammation has been significantly reduced. We are also seeing really 28:00 amazing results in lipid profiles. um part of its weight loss, but there is a 28:06 component to this that is lowering the triglyceride levels because it’s related to sugar and how the body’s processing 28:11 it. And we’re seeing better profiles, less need for statins as a result of 28:17 that. If if you want to listen to my episode on statins, I have one on that. Uh they are not my favorite medication. 28:24 I think it’s overprescribed and overused um and not really affecting or 28:29 addressing the problem. So these things can really be helpful. There’s also some 28:34 uh ramblings going on with GLP-1s saying that they may be able to help with 28:40 addiction in the future because of where they’re finding it affecting the brain and how it affects the food noise and 28:47 the cravings that we have for food and the addiction for food. Could it potentially help with other addictions 28:53 down the road? We’ll have to wait and see on that one. So semiglutide’s FDA prescribing information also includes a 29:00 box uh boxed warning about thyroid sea cell tumors. So in rodent studies 29:06 semiglutide caused dose dependent and treatment duration dependent sea cell 29:12 tumors at clinically relevant exposures. So while it’s unknown whether or not 29:17 semiglutide causes uh thyroid cancer tumors in humans and the rodent thyroid biology 29:26 differs significantly from humans, the drug is contraindicated in patients with a personal or family history of 29:33 medillary thyroid carcinoma or in patients with multiple endocrine neopl neoplasia syndrome type two. it is 29:42 uh contraindicated for safety effects with that. Um I have seen endocrinologists okay GLP1s to be used 29:50 in patients who’ve had other forms of thyroid cancer just not the meillary 29:55 thyroid cancer. So there is possibility there. Now the most common side effects 30:00 are gastrointestinal. It’s nausea affects about 20 to 44% of patients 30:06 depending on the formulation with diarrhea, vomiting, constipation, abdominal pain, and also frequently 30:13 reported in clinical trials. I see this in my clinic, too, especially dose dependent. Um, and it happens early on 30:20 when you’re first starting the medication, but seems to settle out over time. The one that I would add to this 30:26 that I don’t think they have on here is an increase in acid reflux. We also see that quite often uh especially in people 30:33 who suffer with acid reflux to begin with. Now these effects are typically most 30:40 pronounced during the escalation and they like I said often improve over time 30:45 but more serious but less common adverse effects include acute pancreatitis. 30:51 The medication needs to be discontinued immediately if this is confirmed. You can see some diabetic retinopathy 30:57 complications in patients with pre-existing retinopathy and acute kidney injury. Um, this usually happens 31:05 secondarily to dehydration from the GI effects. There are some gallbladder disease um that can occur and people who 31:13 have a sensitive gallbladder will describe uh discomfort with that. I’ve 31:18 even seen some people who’ve had their gallbladder out on GLP1s at the higher doses complain of similar pain that they 31:25 used to have when their gallbladder was in. So, really important to just kind of monitor these symptoms and work closely 31:32 with somebody that understands them and can be on top of them quite quickly if this happens. Excuse me. From an 31:39 integrative medicine perspective, semiglutide really represents a powerful tool, but it’s not a standalone 31:46 solution. Remember, the medication addresses one aspect of the metabolic dysfunction, the signaling systems 31:53 controlling appetite and glucose homeostasis, but it doesn’t address the root cause that led to the metabolic 32:00 disease in the first place. Patients who rely solely on the medication without addressing the ultrarocessed food 32:07 consumption, the ccadian disruptions, the chronic stress, the sleep apnea, or 32:12 underlying hormonal imbalances often experience weight regain when the medication is discontinued. 32:20 The drug is also not a substitute for addressing the emotional and psychological drivers of eating 32:26 behavior, including the unresolved trauma that may manifest as emotional eating. I think this is really important 32:33 because we don’t address the trauma issue enough with clients and we need to 32:38 be looking at that. There is a huge trauma effect out there these days that is I don’t want to say leading to or 32:45 causing but it is definitely contributing to chronic illness and it’s not being talked about enough. So we 32:52 really need to be talking about this and addressing this trauma aspect. Now the next GLP that one that I want to talk 32:59 about is trespathide. This is a dual agonist. It takes center stage. It is my 33:05 favorite GLP one. Trisepatide is marketed as Mangjaro for type 2 diabetes 33:11 and Zepbound for chronic weight management and it represents the next 33:16 evolution in increantbased therapy. This is a dual agonist a 39 amino acid 33:23 synthetic peptide structurally based on the human glucose dependent insulin tropic peptide so GIP sequence but 33:31 modified to activate both the GIP receptors and the GLP1 receptors. So the 33:37 addition of the GI GIP agonism to the GLP1 agonism appears to create this 33:46 synergistic effect that goes beyond simply adding the two mechanisms together. So the GIP like GLP-1 is an 33:55 increant hormone secreted by what is called the K cells in response to nutrient intake. It enhances glucose 34:02 dependent insulin secretion but it also effects on atapost tissue metabolism 34:09 potentially improving the insulin sensitivity in fat cells and influencing 34:14 how the body stores and metabolizes fat. So some research suggests that GIP may 34:20 also have effects on energy expenditure though this remains an area of 34:26 investigation. So basically what we’re saying is this drug may actually help 34:32 people who are insulin resistant or insulin sensitive, not just somebody who 34:38 has problems with glucose control. So, this is super exciting because it opens 34:43 up the door for all of these people for decades that we’ve been trying to manage with insulin resistance and trying to 34:50 prevent diabetes and honestly most of the time have been unsuccessful 34:56 unless you can keep your diet at 50 grams of carbs or less a day, which is extremely difficult. Um, and take some 35:04 supplements that may or may not work and or take some metformin that may or may not help. this drug actually really 35:11opens that up and helps in that capacity. So there was a clinical trial 35:17 called the surmount clinical trial which demonstrated that trespathide produces 35:22 even more substantial weight loss than semiglutide. In the surerount one trial published by uh J tree I might have said 35:31 that wrong. I apologize if I slaughtered your name and colleagues in the New York England Journal of Medicine in 2022. 35:38 Participants receiving the highest dose of trespide, which is 15 milligrams, achieved an average weight loss of 20.9% 35:47 of their body weight over 72 weeks, compared to 3.1% with placebo. This 35:54 level of weight loss approaches what’s typically only seen in beriatric surgery. So, this is amazing because if 36:02 this medication works and we don’t have to do beriatric surgery, stomach stapling basically, um, oh my gosh, it’s 36:11 amazing. There are so many complications and risks that go with stomach stapling and the different procedures that they 36:17 do these days. People don’t absorb their nutrients properly. They have to do liquid nutrients. It’s very complicated. 36:24 It’s very challenging. Many of these people gain their weight back. Um, and 36:30 this procedure is not fun to go through. So, if we could change that and change 36:35 the lives of people who’ve really been struggling, it is amazing. And I will tell you that I have seen this work. I 36:42 have seen people lose 100 150 pounds on these medications over a year or two 36:50 period of time. It is definitely slower than beriatric surgery on some standpoints, but that is okay. You don’t 36:56 want that rapid weight loss. It’s not good for you. It’s not healthy for you. It doesn’t look well. You know, we want 37:03 to do this safely and effectively in the best way that we can possibly do that for you. Now, the adverse effect profile 37:10 is similar to semiglutide. It’s dominated by gastrointestinal effects. 37:15 Nausea, diarrhea, decreased appetite, vomiting, constipation. These were all commonly reported in the surmount 37:22 trials. And like semiglutide, tricepide carries a blackbox warning regarding the 37:27 thyroid sea cell tumors based on the rodent data and it shares the same contra indications in patients with a 37:34 family history of thyroid cancer and men too. So the mechanism behind why 37:40 tepatide often produces more substantial weight loss than GLP-1. The agonism 37:45 alone remains under investigation, but it may relate to the complimentary effects on the different aspects of 37:51 energy homeostasis or to GIP’s effects on atapost tissue and potentially on 37:58 central central nervous system pathways that GLP1 alone doesn’t fully address. 38:03 Now patients often report even more profound reductions in food noise with tricepide compared to GLP1 and uh sorry 38:12 GLP1 the agonists through this is anecdotal and hasn’t been regularly 38:17 quantified in quality studies. So I’ve done both uh personally and in my 38:22 practice. I really like trespide better than semiglutide. For me I had too many side effects with semiglutide. uh I had 38:30 less side effects with trespathide. I also plateaued on semiglutide which I 38:35 didn’t really care for. And with Tresepide, I haven’t plateaued and I’ve been able 38:42 to lose about 25 pounds in um a year and a half and I’ve been able to maintain 38:49 that. Um and I continued to use it because I do have a strong family history of cardiovascular disease. And 38:56 if this could help me so that I don’t follow my family lineage with cardiovascular disease, I am all for 39:03 trying to do that. I’ve watched too many of my family members suffer from this. I’ve lost my dad at a very young age. I 39:09 lost my grandfather at a young age to it. All of their brothers to this. And I don’t want to be that same person. So 39:16 that is why I chose to do that. And I think it’s really important for us to take a look at that and understand that. 39:24 Now, I know this has been a really long podcast and I don’t typically do podcasts this long. I have a whole host 39:31 of information on additional peptides. So, I’m going to break this up for you 39:36 guys and I’m going to do another episode and we’re going to pick up where we left off here with these peptides so that we 39:43 can actually start to dive into different peptides as well. So, check 39:48 out my next podcast show when we’re going to dive into the peptides that 39:54 talk about sexual wellness, immune function, and all the other cool things 39:59 that we can do with peptides. So until then, remember to like, share, and 40:04 subscribe. It really helps us get out to other people and share our information, 40:10 and join us for our next episode as we continue the talk about peptides. 40:15 Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you. Please note that the views and 40:21 information shared by our guests are their own and do not necessarily reflect those of Let’s Talk Wellness Now, its 40:28 management, or our partners. Each affiliate, sponsor, and partner is an 40:34 independent entity with its own perspectives. Today’s content is provided forformational and educational 40:40 purposes only and should not be considered specific advice, whether financial, medical, or legal. While we 40:48 strive to present accurate and useful information, we cannot guarantee its completeness or relevance to your unique 40:56 circumstances. We encourage you to consult with a qualified professional to address your 41:01 individual needs. Your use of information from this broadcast is entirely at your own risk. By continuing 41:08 to listen, you agree to indemnify and hold Let’s Talk Wellness Now and its 41:14 associates harmless from any claims or damages arising from the use of this 41:20 content. We may update this disclaimer at any time and changes will take effect 41:26 immediately upon posting or broadcast. Thank you for tuning in. We hope you 41:31 find this episode both insightful and thought-provoking. Listener discretion 41:36 is advised.The post Episode 256 – How Peptides Work, Benefits, and FDA-Approved vs Off-Label Use Explained first appeared on Let's Talk Wellness Now.

In this episode of Data in Biotech, Ross Katz sits down with Kyle Smith and Jacob Mayer from Aprecia Pharmaceuticals to explore how 3D printing is transforming pharmaceutical manufacturing. They dive into the unique binder jetting process, in-cavity printing, and how real-time data and automation are enabling agile, scalable, and precise drug production. Discover how Aprecia's approach is changing the game for clinical trials and personalized medicine. What you'll learn in this episode: >> How Aprecia developed the world's first FDA-approved 3D printed drug >> Why binder jetting stands out among 3D printing methods in pharma >> How in-cavity 3D printing enables real-time tablet-level data collection >> The future of closed-loop control and digital twins in drug manufacturing >> Why 3D printing is key to agile, distributed, and personalized pharma production Meet our guests: Kyle Smith is President and COO of Aprecia Pharmaceuticals, leading strategic growth and innovation in GMP-regulated pharma manufacturing. With 12+ years at Aprecia, he brings deep expertise in engineering, operations, and technology transfer. Jacob Mayer is Director of Engineering Innovation at Aprecia Pharmaceuticals. With a decade of experience across automation, additive manufacturing, and life sciences, he leads the advancement of 3D printing technologies and integrated pharma systems. About the host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with our guests: Sponsor: CorrDyn, a data consultancyConnect with Jacob Mayer on LinkedIn Connect with Kyle Smith on LinkedIn Connect with us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.The conversation explores why Western companies often underestimate China's regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T).The episode dives into China's local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration.Elaine also outlines how China's quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers.Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China's device classification system can influence regulatory strategy.⏱️ Timestamps00:00 Welcome + Meet Elaine (MedTech Chopsticks)00:38 Why China Is Different: Local Standards vs EU/US Assumptions03:35 GB & YY Standards Explained (National vs Industry Standards)05:07 Local Type Testing & PTRs: Building China Product Technical Requirements06:52 China GMP Updates: Key Differences vs ISO 1348512:42 China Agent vs EU Authorized Rep: Roles & Responsibilities15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks24:43 China Certification & Device Classification Changes (Class I/II/III)28:38 Where to Find Elaine + ClosingSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing. Together, they explore the realities of GxP compliance in biopharma manufacturing — from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector.   Key Takeaways 02:11 Why biologics manufacturing is fundamentally more complex than small molecule production 04:10 How living cell systems introduce variability and demand tight process control 05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone 10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance 13:06 The growing demand for advanced quality skills in biologics and digital environments 17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches 20:47 Why automation and digitalization are critical to closing the CDMO capacity gap   Contact Paul Michel on LinkedIn here: Paul Michel (He/Him) | LinkedIn Contact us at solabs-podcast@solabs.com for questions or feedback!

Send a textMike Romance has spent nearly two decades operating at the intersection of manufacturing engineering, automation, validation, and operations leadership within the life-sciences ecosystem. His career spans startups and established organizations alike, with hands-on experience taking products from early development through GMP-ready, high-volume production. Across roles in process development, automation, quality systems, and manufacturing strategy, Mike has built a reputation for combining technical rigor with pragmatic execution.Most recently at Quantum-Si, Mike played a central role in scaling operations to support the commercialization of the Platinum protein sequencing platform while laying the groundwork for next-generation technologies like the Proteus platform. Working within a lean and highly agile leadership team, he helped establish scalable manufacturing foundations spanning CM-managed instrument supply, internal reagent kit production, and advanced silicon-based consumables—while navigating the realities of fast-moving product roadmaps and constrained resources.Earlier in his career, Mike held engineering and leadership roles at organizations including Illumina, Dexcom, GenMark Diagnostics, Truvian, and Encodia. Along the way, he's led pilot-line development, automation strategy, equipment qualification, validation programs, and process controls—often in environments where the path forward wasn't clearly defined.What sets Mike apart is not just his command of acronyms—GAMP, CQV, QbD, DFSS, FMEA—but his philosophy that systems only work when people do. He actively practices emotionally intelligent leadership, prioritizing trust, clarity, and psychological safety while still holding teams to high technical and operational standards. As Mike explores his next chapter, this conversation focuses on the lessons he's learned building resilient manufacturing systems—and the kind of organizations where he believes he can make the biggest impact next.LINKS:Guest LinkedIn: https://www.linkedin.com/in/mikeromance/Aaron Moncur, host The Wave is  a place for engineers to actively learn, share ideas, and engage with people doing similar work. Learn more at thewave.engineer Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us Watch the show on YouTube: www.youtube.com/@TeamPipelineus

When your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperature shifts that compromise titer, kifunensine supplementation that requires extensive regulatory justification, or 12-18 months to reclone and revalidate. Media supplementation offers an alternative pathway—tuning glycan profiles through formulation adjustments rather than cell line or process re-engineering.In this episode, David Brühlmann presents the experimental development of a media supplementation strategy that achieved 2.8-fold increases in high mannose glycans across multiple CHO cell lines. Drawing from research published in the Journal of Biotechnology (2017, 252:32-42), the discussion covers the mechanism of raffinose-mediated glycan processing arrest, the experimental variables that initially obscured the effect, and the process development considerations for implementing media-based glycan tuning.The episode examines N-glycan biosynthesis in CHO cells, regulatory comparability requirements for biosimilar glycosylation profiles, and the experimental framework for evaluating media supplementation as a glycan control strategy.Highlights from the episode:The unexpected link between dietary raffinose and reduced athletic performance, and its connection to bioprocessing (01:11)A clear primer on the importance of glycosylation for biosimilar drugs and regulatory approval (02:43)Common challenges when glycan profiles don't match reference products, and why high mannose glycans matter (04:19)A review of industry strategies (temperature shifts, enzyme inhibitors, cell line reengineering) and their pitfalls (05:33)Mechanistic insights into how raffinose alters glycan processing in CHO cells (07:05)Key experimental findings on raffinose concentration, osmolality control, and practical lab troubleshooting (09:48)Application stories and regulatory considerations for implementing raffinose-based media adjustments (13:47)Closing thoughts on process optimization, regulatory impact, and what to expect in Part 2 (15:11)Strategic insight:Implementing raffinose as a media supplement is straightforward, regulatory-friendly, and cost-effective. It does not involve genetic engineering or enzyme inhibitors and is easily sourced as a GMP-grade material. For programs approaching submission with glycan comparability gaps, media-based tuning offers a process optimization pathway that maintains existing cell lines and manufacturing platforms while addressing critical quality attribute specifications.Listen to this episode of the Smart Biotech Scientist Podcast to learn David's best strategies for rapid, regulatory-friendly glycosylation control.If you want to transform your glycoengineering workflow, keep an eye (and ear) out for the next episode of the Smart Biotech Scientist Podcast. Your path to regulatory success might be as simple as a pinch of raffinose.Resources: Journal of Biotechnology, 2017, volume 252, pages 32 to 42Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Ever feel like your supplement cabinet is full but your energy is still empty? We take you behind the label to show exactly why some products change lives and others change nothing. With Emily from Orthomolecular, we unpack the real markers of quality—verified sourcing, GMP manufacturing, third-party testing, and forms your cells can actually use—so you stop guessing and start feeling a difference.We start with the fish oil you love to hate. If your softgels smell rancid, cause burps, or require a handful to hit a therapeutic dose, you're not imagining it. Source, processing, and form separate effective EPA/DHA from junk. Then we tackle magnesium: oxide and citrate may keep you regular, but chelated bisglycinate supports sleep, mood, heart rhythm, and muscle calm because it gets inside cells. We also talk about the digestion piece too many overlook—low stomach acid from stress or long-term PPIs can block absorption, turning even good formulas into expensive decorations.From there, we map the essentials most women need: vitamin D3 with K2 to protect bones and arteries, omega-3s to dial down inflammation, and an advanced multivitamin with activated B vitamins for energy, methylation, and hormone metabolism. On gut health, we share why a multi-strain, shelf-stable probiotic can be a smart daily “maintenance” choice, and how Saccharomyces boulardii acts like a cleanup crew for the GI tract, helping maintain barrier integrity and support immunity.If you're ready to simplify, we explain how to audit your cabinet, check forms and doses, toss expired or ineffective products, and consolidate into a lean, therapeutic stack that works. No hype—just practical steps, clear explanations, and products designed to meet label claims and clinical standards. Subscribe, share with a friend who's supplement-confused, and leave a review telling us the one change you're making this week.Shop supplements: Shop.fasttofaith.com use code PODCAST for a discount! If you're ready to move beyond trying harder and start living more aligned, you're invited to join Empowered by Faith — LIVE, a guided 5-day reset led by Dr. Tabatha that helps women reset body, mind, and spirit through simple, faith-centered rhythms.

Kim Bright is a pioneering figure in the nutrition industry, recognized as an expert in health and wellness. She has been active since the 1980s, appearing on nationally syndicated and local radio and television programs to educate audiences on optimizing their health. Over her career, she has personally consulted with more than 15,000 individuals and delivered lectures to groups across the United States. Bright studied under well-known health experts and industry leaders, and she both attended and taught at The Kushi Institute in Massachusetts. She established a health center in Connecticut, where she offered consultations and taught courses on healthy lifestyles alongside international health experts. In 1985, Bright opened A Change of Season’s Restaurant in Westport, Connecticut, which was the state’s first non-smoking restaurant. As its chef and owner, she emphasized locally sourced, seasonal organic ingredients, with a menu featuring fresh fish, organic chicken, daily-made soups, salads, juices, breads, cookies (including gluten-free options), desserts, macrobiotic dishes, and vegetarian and vegan selections—no processed foods, red meat, or alcohol were served. In 1996, Bright founded Brightcore Nutrition, a family-owned nutraceutical company now in its 27th year as of recent profiles Brightcore’s products are manufactured in the USA in FDA-inspected, GMP-certified facilities, with ingredients rigorously researched and third-party tested for potency, quality, and safety. By selling directly to consumers, the company maintains premium quality at accessible prices. Bright’s work with Brightcore has included discussions on topics like the benefits of fermented foods and wheatgrass juice powder for energy and skin health in various interviews and podcasts 

Episode Description You trust that expensive fish oil is molecularly distilled and free from mercury. You believe your magnesium is actually absorbed. You assume your creatine is pure pharmaceutical-grade powder. But can these brands prove it—or are you swallowing contaminated, oxidized, low-potency supplements that do more harm than good? Dr. Christian Gonzalez investigated the supplement industry with one critical question: can the most popular longevity supplements prove they're free from heavy metals, microplastics, and oxidation through third-party testing and Certificates of Analysis (COAs)? The shocking reality? Most can't—or won't—provide basic proof of purity. You're expected to trust your mitochondria, brain health, and long-term performance to manufacturers who refuse transparency about what's actually in the bottle. The hidden dangers lurking in "premium" supplements: • Fish oils contaminated with mercury, lead, microplastics, and oxidized rancid fats that trigger inflammation instead of reducing it • Magnesium oxide marketed as "magnesium" with 4% absorption—meaning you're literally flushing your money down the toilet • Creatine cut with heavy metals, banned substances, and fillers that negate performance benefits and contaminate your system • Vitamin D formulated in seed oils and synthetic carriers that interfere with absorption and create inflammatory byproducts • Fiber supplements loaded with inulin blends and maltodextrin that spike blood sugar and cause severe digestive distress • Zero verification of potency claims—dosages listed on labels that have no relationship to what third-party testing reveals inside • Supplements stored in conditions that degrade active ingredients months before expiration dates In this episode, Dr. Christian Gonzalez reveals: • The 5 most studied supplements for longevity, brain power, and energy—and exactly how to buy the cleanest versions • Why Omega-3 fish oils are either your greatest longevity tool or a toxic inflammatory bomb depending on purity testing • The one form of magnesium that actually works (and the three forms that are complete scams stealing your money) • How creatine monohydrate boosts ATP in your muscles AND brain—but only if it passes strict third-party certification • Why Vitamin D without K2 can calcify your arteries while you think you're "optimizing" your health • The soluble fiber that lowers all-cause mortality by 11%—and why most fiber supplements use the wrong type • Exact evidence-based doses, timing strategies, and quality markers so you never waste money on fairy dust formulas again • The certifications that actually matter: IFOS, NSF, Informed Sport, Creapure, and why "GMP certified" means nothing • How to read COAs and spot red flags in oxidation scores, heavy metal panels, and microplastic screening This episode goes beyond basic supplementation—it's about understanding that your cellular membranes, mitochondrial function, and long-term disease prevention depend on purity, not marketing. It's about demanding proof before putting daily supplements into your body, and recognizing that the supplement industry profits from your trust, not your health outcomes. The supplement industry doesn't want you asking for COAs. But your brain, heart, and longevity depend on it. My one stop shop for quality supplements: https://theswellscore.com/pages/drg Timestamps: 0:00 - Introduction 1:07 - #1: Omega-3s for Brain & Longevity  4:41 - How Much Omega-3 Do You Actually Need?  7:42 - #2: Magnesium for Energy & Nervous System  12:42 - #3: Creatine for Muscle & Brain Energy  16:07 - #4: Vitamin D3 + K2 for Immune & Bone Health  20:22 - #5: Soluble Fiber for Gut Health & Longevity