Podcasts about GMP

How do you take a model that works in process development and get it accepted for use in GMP manufacturing? That question stalls most bioprocess modeling projects before they start. Ignasi Bofarull-Manzano, Senior Data Scientist and CMC Consultant at Körber Pharma, pushes back on the premise: the process you run today is already governed by a mathematical model, fitted once at small scale during process characterization and then left untouched for years, even as the process shifts.Part 1 separated digital models from digital shadows and digital twins, and made the case for starting with the decision rather than the data. Part 2 goes into the plant: what regulators actually require, what the numbers looked like on a real biologics process, and where a team should start on Monday morning.Topics covered:Core differences—and surprising similarities—between modeling in development versus manufacturing (02:35)Regulatory requirements: credibility assessments, model risk, and validation steps for digital twins (05:07)Real-world example: How deploying an end-to-end process model led to 35% yield increase for Takeda, and considerations for ROI in manufacturing (08:34)Advice for startup leaders on when to invest in modeling and how to scale efforts case-by-case (11:42)Steps for scientists new to modeling: identifying bottlenecks, starting simple, and proving value offline before scaling up (12:26)The importance of understanding basic statistics before relying on AI-generated models (15:22)A stepwise summary for deploying digital modeling effectively in biotech (16:01)Smart insight: The digital twin is the last step, not the first. Identify the bottleneck, build the simplest model that supports the decision, and concatenate it end to end so you can see how a parameter moves final drug substance quality rather than one unit operation's output. Prove the value offline. Only then connect interfaces, because that is where the cost and the validation burden live. Teams that lead with the twin arrive at the C-level with a proof of concept and no evidence. Teams that lead with the offline model arrive with a number.Before a digital twin can earn its keep, you need connected data, the right model, and a clear decision for it to support. These four episodes cover that ground — data silos, hybrid and mechanistic modeling, and twins built to survive regulatory scrutiny.Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya BurkovEpisodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovEpisodes 17 - 18: How Extracting Gold From Your Data Accelerates Process Development with Ioscani Jiménez del ValEpisodes 263 - 264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David HardyConnect with Ignasi Bofarull-Manzano:LinkedIn: www.linkedin.com/in/ignasi-bofarullKörber Pharma website: www.koerber-pharma.comSupport the show

At CDMO Live Europe 2026, Jeff Mason, VP and Head of US Sales at Samsung Biologics, demonstrated a risk-based, parallel approach to dual-site technology transfer that delivered a first GMP batch at a second facility within 90 days of initiation.Read the full article.

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today.In this video, I walk through where PI 006-4 fits within the broader GMP framework, how it relates to EU Annex 15, and the sections I think are most worth paying attention to.A few of the major themes include a much stronger emphasis on quality risk management and lifecycle thinking, more explicit expectations around statistics, sampling, variability, and process capability, a move away from treating three validation batches as a default answer, and clearer discussion of traditional validation, continuous process verification (CPV), hybrid approaches, and ongoing process verification (OPV).The goal isn't to suggest that all of these concepts are brand new. Many have been developing across the industry for years. What is interesting is seeing how PIC/S has now pulled them together into an updated recommendation that reflects current qualification and validation thinking.Chapters00:00 Big Update Overview01:02 Who PIC/S Serves01:28 Annex 15 Relationship02:12 Scope and Exclusions02:39 Why Update Now04:05 Four Key Changes04:47 Risk and Lifecycle Shift06:43 Statistics and Sampling07:48 Rethinking the Three-Batch Rule08:30 Ongoing Process Verification09:11 Traditional, CPV and Hybrid Approaches10:45 Key TakeawaysAbout SubhiSubhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let's Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.Connect With Let's CombinateWebsite:https://www.letscombinate.comSchedule an intro call:https://calendly.com/letscombinate/let-s-combinate-intro-sessionLinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792Spotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2Documents DiscussedPIC/S PI 006-4 — Recommendations on Qualification and Validation (2026)https://picscheme.org/docview/11277PIC/S PI 006-3 — Validation Master Plan, IQ/OQ, Non-Sterile Process Validation & Cleaning Validation (2007)https://picscheme.org/docview/3447EMA / PIC/S Concept Paper — Revision of Annex 15: Qualification and Validation (2026)https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdfPIC/S Publications Pagehttps://picscheme.org/en/publications

This Episode Ryan and Steven Watts of Red River Development join Chris to break down the build-to-rent market, why Red River focuses on secondary markets, and how recent housing legislation could reshape the future of single-family rental investing. Ryan and Steven share how their backgrounds in energy, banking, construction, development, and property management led them to launch Red River in 2020, right as COVID was reshaping housing demand and capital markets. Since then, the company has grown to more than 2,200 units and roughly $690 million in assets under management, with a focus on purpose-built rental communities designed for renters who want more space, privacy, and flexibility than traditional apartments can offer. The conversation also digs into the 21st Century ROAD to Housing Act and why early Senate language could have been highly disruptive to the build-to-rent industry. Steven explains why the final version was ultimately positive for BTR, how it preserved the distinction between scattered-site single-family rental aggregation and purpose-built rental communities, and why institutional capital may increasingly shift toward BTR as a result. Chris, Ryan, and Steven also get tactical on Red River's current Waco, Texas project: a 206-home Trulo Homes community on 20 acres near major retail, entertainment, downtown Waco, and Baylor University. They walk through the capital stack, construction debt, personal guarantees, commercial construction approach, phasing strategy, and how Red River de-risks development by lining up permits, contractors, GMP pricing, and leasing phases before and during construction. Key takeaways: How Ryan and Steven's backgrounds led to the launch of Red River Development Why build-to-rent serves renters graduating out of apartments or downsizing from homeownership How the 21st Century ROAD to Housing Act changed from a potential BTR headwind into a positive catalyst Why institutional capital may move away from scattered-site rentals and toward purpose-built BTR communities What Red River looks for in secondary markets, suburban sites, demographics, schools, retail access, and job centers How the Waco project is structured, including a 65% loan-to-cost construction loan and a $55 million total capitalization Why Red River uses a commercial construction approach to build faster and reduce execution risk Join a community of passive investors. Start your FREE 7-day trial: https://passivepockets.com/?utm_source=youtube&utm_medium=description&utm_campaign=none Listen to the PassivePockets Podcast Anywhere: https://lnk.to/passivepockets Subscribe to the Passive Investing Newsletter: https://www.biggerpockets.com/email-subscribe?utm_source=youtube&utm_medium=description&utm_campaign=none Join BiggerPockets for free: https://www.biggerpockets.com/signup?utm_source=owned_media Disclaimer The content of this podcast is for informational purposes only. All host and participant opinions are their own. Investment in any asset, real estate included, involves risk, so use your best judgment and consult with qualified advisors before investing. You should only risk capital you can afford to lose. Past performance is not indicative of future results. This podcast may contain paid advertisements or other promotional materials for real estate investment advisers, investment funds, and investment opportunities, which should not be interpreted as a recommendation, endorsement, or testimonial by PassivePockets, LLC or any of its affiliates. Viewers must conduct their own due diligence and consider their own financial situations before engaging with any advertised offerings, products, or services. PassivePockets, LLC disclaims all liability for direct, indirect, consequential, or other damages arising out of reliance on information and advertisements presented in this podcast.

How do you turn a lab-born regenerative medical device into a solution that surgeons actually want to use and investors want to back? The path from academic innovation to clinical adoption is full of practical hurdles and strategic pivots, where compelling science alone isn't enough.David Brühlmann welcomes back Eva-Maria Balet, whose journey spans tissue engineering research at EPFL to leading Regenosca through first-in-human trials, fundraising, and an executive MBA completed while running the company. This conversation covers the practical realities behind that journey, from quality control to clinical setbacks to investor pitches.Topics discussed:Defining TissueSpan's regulatory path and quality control as a medical device (02:49)The significance of first-in-human studies and what early clinical experience reveals (04:11)Selecting an initial clinical indication and opportunities for technology expansion (05:50)Realistic assessment of where soft tissue repair technologies apply—and where they do not (07:18)The stepwise progression from in vitro to animal models in product development (08:18)Navigating setbacks, including the impact of Covid-19 on clinical trials, and the value of adaptability (10:36)Bridging science and business in biotech fundraising and communication (12:15)Key takeaways from pursuing an executive MBA alongside building a biotech company (13:42)The importance of collaboration, mindset, and meaningful networks in driving biotech innovation (15:19)Smart insight: The transition from scientist to founder brought its own learning curve. Eva-Maria pursued an executive MBA while running Regenosca, and points to financial and business vocabulary as the skill she'd have built earlier if she could. For a technical founder or CMC lead, the lesson isn't to become a business generalist, it's that the moment you're translating a manufacturing process or clinical dataset into an investor pitch, fluency in the language of accounting, market strategy, and cost structure becomes as load-bearing as the science itself.This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery.Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan TomicEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoConnect with Eva-Maria Balet:LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.comSupport the show

Send us Fan MailFor most of human history, scientists believed that once a cell became a skin cell, a neuron, or a heart cell, that identity was permanent. Then a group of researchers discovered something extraordinary: cells could be reset. My guest today was there when that discovery happened.Dr. Koji Tanabe, Ph.D. is Founder and CEO of I Peace ( https://ipeace.com/en/ ), one of the world's leading companies advancing induced pluripotent stem cell - or iPSC - technology from the research laboratory into scalable clinical manufacturing.Dr. Tanabe occupies a truly unique place in modern biomedical history. He earned his Ph.D. in the laboratory of Nobel Laureate Dr. Shinya Yamanaka at Kyoto University and was the second author on the landmark scientific paper that first demonstrated the successful creation of human induced pluripotent stem cells - a discovery that fundamentally changed regenerative medicine and ultimately earned Dr. Yamanaka the 2012 Nobel Prize.After helping establish one of the most important technologies in modern biology, Dr. Tanabe continued his work at Stanford University in the laboratory of Dr. Marius Wernig, a pioneer of direct cellular reprogramming, where he investigated how mature blood cells can be directly converted into neurons and explored the molecular mechanisms that govern cellular identity.In 2015, Dr. Tanabe founded I Peace with an ambitious vision: to make clinical-grade iPS cells accessible at industrial scale. Today, the company has developed automated GMP manufacturing platforms capable of producing personalized and clinical-grade iPS cells for researchers, pharmaceutical companies, and regenerative medicine programs around the world.On the episode we'll explore how far the field has come since those first groundbreaking experiments nearly two decades ago, where regenerative medicine stands today, the growing role of iPS cells in drug discovery and transplantation, the excitement surrounding in vivo reprogramming and partial cellular rejuvenation, and what may ultimately become possible when every individual has access to their own personalized stem cell bank.Important Episode Links - Future Medicine Lab with Koji Tanabe YouTube Channel -https://www.youtube.com/@FutureMedicineLabMy Peace (a service from I Peace) - Personal iPS Cell Banking Service - https://mypeace-personal-ipscbanking.com/en/#iPSC #StemCells #RegenerativeMedicine #CellularReprogramming #ShinyaYamanaka #NobelPrize #Biotechnology #Biotech #Longevity #AgingResearch #FutureMedicine #PrecisionMedicine #DrugDiscovery #CellTherapy #GeneEngineering #BiomedicalResearch #LifeSciences #HealthcareInnovation #MedicalInnovation #Science #Technology #Innovation #FutureOfMedicine #StemCellResearch #HumanBiology #SyntheticBiology #AIinMedicine #PharmaInnovation #DiseaseModeling #RegenerativeTherapySupport the show

Harry Jowsey joins Howie Mandel Does Stuff for a hilarious and unpredictable conversation, teasing possible spoilers for his new series Let's Marry Harry while sharing stories about dating, reality TV, and life in the spotlight. Just when he thinks the surprises are over, an unexpected reunion with a former Too Hot to Handle contestant turns the episode into one you won't want to miss. Visit Official PASH website here: https://getpash.com/ Howie Mandel Does Stuff available on every Podcast Platform Visit the Official Howie Mandel Website for more: https://www.howiemandel.com/ Howie Mandel Does Stuff Merchandise available on Amazon.com here https://www.amazon.com/shop/howiemandeldoesstuff Join the "Official Howie Mandel Does Stuff" Reddit: https://www.reddit.com/r/HowieMandelPodcast/ Thanks to our sponsors: Still relying on caffeine just to feel normal, only to crash later? This formula is designed to support cleaner, steadier energy and sharper focus with Enfinity®, featuring pure paraxanthine instead of traditional caffeine. No blends, no guesswork, just a simple capsule made in a GMP-certified U.S. facility. If you're ready for energy that works with you, not against you, use code HOWIE10 for 10% off at Vita Bloom Labs. When “lightweight” actually means lightweight, everything changes. The Smarti Plus from Monarch Mobility is designed to make everyday movement easier with a one-touch automatic fold, a 35-pound frame, and features like rear suspension, LED lighting, and USB ports to keep up with real life. Built for comfort and independence, it delivers up to 9 miles of range without the usual hassle. If mobility has ever felt harder than it should, find a local authorized Monarch Mobility dealer to experience the Smarti Plus. Welltayl is a dog care brand built around one simple idea: skin health comes first. Most dog shampoos are designed around fragrance, but dogs are highly sensitive to scent, which can lead to irritation, scratching, and licking. Welltayl's Coat Wash + Conditioner is vet-derm formulated, fragrance-free, and EWG-verified, so pet parents can care for their dog's coat without compromising their skin. Learn more at welltayl.com Taking care of yourself should feel simple, reliable, and built for real life. This brand focuses on straightforward wellness for men, offering science-backed supplements, fragrances, and personal care designed to support everyday confidence and routine. It's all about feeling more prepared and in control without overcomplicating things. Head to cocksman.co and use code HOWIE15 for 15% off. Say Hello to our house band Sunny and the Black Pack! Follow them here! YouTube: https://www.youtube.com/@BlackMediaPresents TikTok: https://www.tiktok.com/@blackmediapresents Spotify: https://open.spotify.com/artist/01uFmntCHwOW438t7enYOO?si=0Oc-_QJdQ0CrMkWii42BWA&nd=1&dlsi=a9792af062844b4f Facebook: https://www.facebook.com/SunnyAndTheBlackPack/ Instagram: https://www.instagram.com/blackmediapresents/ Twitch: https://www.twitch.tv/blackmediapresents Twitter: twitter.com/blackmedia @howiemandel @jackelynshultz @HarryJowsey

Imagine a wound too large for the body to close on its own. That's the problem Eva-Maria Balet set out to solve, not with living cells, but with a structural bridge that lets the body's own healing mechanisms do the rest.In this episode, David Brühlmann welcomes Eva-Maria Balet, Co-Founder & CEO of Regenosca. Trained at EPFL, Eva-Maria brought her fascination with cellular "factories" from academia straight into entrepreneurship. Rather than chasing elegant science for its own sake, she built her company around a single principle: start with a real clinical need and build backward, collaborating with clinicians from day one so every experiment serves a patient.Highlights & Topics:Why starting with clinical needs—not just scientific excitement—creates meaningful real-world impact in life sciences (02:38)How Eva-Maria's fascination with biotechnology guided her from cell factories to developing scaffolds for tissue repair (03:51)The unmet challenges in current soft tissue repair treatments and where new solutions are needed (05:51)What makes Regenosca's fully-engineered collagen implant, TissueSpan, different from existing meshes and biological materials (07:09)The biological mechanisms behind tissue regeneration using a temporary collagen scaffold (08:28)Translating lab-scale research into a robust, scalable, and regulatory-compliant production process (10:34)The practical realities and hurdles of navigating the medical device vs. biologic regulatory pathways (11:59)Advice on building regulatory expertise into your founding team or leveraging consultants effectively (13:31)The importance of interdisciplinary teams and trust when forming biotech startups (14:36)Smart insight: Eva-Maria put it plainly: what works in the lab has to work reliably every single time you produce it for a patient. That shift, from proving a concept to controlling a process, from raw materials through in-process controls to final product testing, is the same discipline any CMC scientist recognizes: science alone doesn't get a product to patients. Reproducibility does.This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery.Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan TomicEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoConnect with Eva-Maria Balet:LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.comSupport the show

We asked Scoreboard AI's Charles Ma what the single most expensive mistake contractors make at buyout is. His answer:"Outsourcing their understanding of the project to their trade partners."Charles was employee #1 at Versatile, one of construction tech's most well-funded bets (over $100M raised). Now he's building Scoreboard AI to fix a much quieter problem: scope gaps that get buried in project documents and don't surface until the crew is standing there waiting for a fix.In this episode we get into:- What Versatile got right, and where the product fell short of the ROI it promised- Why Charles thinks "AI wrappers are dead" in preconstruction- How hard bid, GMP, and design-build buyout processes each create their own scope gap risk- Why Scoreboard has deliberately stayed away from flashy fundraise announcementsFull episode is live on Bricks and Bytes Youtube Channel#bricksandbytes #bricksbytes #aec #construction #constructiontech #ai #vcChapters00:00 - Teaser01:00 - Quickfire Round02:32 - Inside Versatile: the early days and the Chase Center project09:27 - Is construction tech overhyped or underhyped right now11:10 - Why Scoreboard has avoided the flashy fundraise playbook16:43 - The perverse incentives of VC-backed construction tech20:21 - Do "AI wrappers" win the current land grab26:02 - Why Charles believes AI wrappers are dead28:25 - What a scope gap actually is, and why it happens at buyout32:55 - Hard bid vs. GMP vs. design-build: where the gaps creep in36:50 - Measuring the real cost of scope gaps41:51 - How Scoreboard AI actually works43:21 - Show your work: building trust in AI outputs48:59 - Pricing philosophy: running Scoreboard like a Costco51:26 - Expansion beyond the US52:41 - What's working in go-to-market right now54:08 - Will AI ever run preconstruction end-to-endOur Sponsors:BreadCrumb- 50,000+ projects globally. All running safer, faster, with Breadcrumb. - breadcrumb.coAphex is the multiplayer planning platform where construction teams plan together, stay aligned, and deliver projects faster – check out aphex.coArchdesk - “The #1 Construction Management Software for Growing Companies - Manage your projects from Tender to Handover” check archdesk.com

“Projects quite often realize too late that their R&D process cannot just be copy-pasted from the lab into the manufacturing facility.”Dr. Jenny Prange is Head of Project Management at the Regenerative Medicine Technologies Platform (RMTP) at Wyss Zurich, an accelerator embedded within ETH Zurich and the University of Zurich. With a background spanning molecular biotechnology, a PhD in human physiology, and hands-on experience translating an advanced therapy medicinal product (ATMP) from bench to clinical trial at University Hospital Zurich, Jenny brings both scientific depth and manufacturing expertise to early-stage biotech projects.In this PharmaSource podcast episode, Jenny explains why the leap from academic research to GMP-ready clinical manufacturing is consistently underestimated, what it actually takes to build a robust CMC strategy, and how translational facilities like Wyss Zurich are filling a critical gap in the biotech development landscape.Read the full article.

In the biotech industry, advancing cell-based therapies is not just about innovation. It's about solving real gaps where conventional treatments fall short, especially against complex, aggressive tumors.In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Jun Yung Woo, Co-Founder of AGEM Bio, who offers an in-depth look at the science and strategy behind engineered mesenchymal stem cells (MSCs), with a focus on why glioblastoma is the right proving ground for the platform.Topics discussed:Why glioblastoma is the right Phase I indication: infiltrative growth, immunosuppression, and STING pathway deficiencies that make GBM uniquely suited to the platform (02:43)The surgical workflow: intracavity MSC delivery during tumor resection, oral 5-FC administration, and how engineered cells act as local bioreactors in the resection cavity (04:05)Mechanisms by which engineered MSCs target heterogeneous and invasive tumors through shared vulnerabilities rather than antigen recognition (05:58)Overcoming immune rejection with allogeneic therapies and the unique immunological profile of MSCs (07:32)Manufacturing and scale-up: addressing donor variability, GMP production, and building a reproducible process (09:16)Why GMP manufacturing should be designed in from the earliest stages of research (10:50)Beyond glioblastoma: expanding the platform to other solid tumors, regenerative medicine, and chronic inflammatory disease (11:27)Strategies for international trial expansion and partnerships beyond Singapore (12:41)Reframing MSCs from stem cell therapy to programmable delivery platform: the MSC 2.0 thesis (14:10)Smart insight: The shift Jun Yung articulates is from treating stem cells as the therapy to treating them as programmable therapeutic vehicles. Once you can reliably engineer, manufacture, and preserve their function, the limitation is no longer what the cell naturally does. It becomes what biology you can encode into it. Glioblastoma is the proving ground, and the platform's reach extends to liver cancers, sarcomas, peritoneal malignancies, and chronic inflammatory disease.These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies:Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay DaviesEpisodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta LeeEpisodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon ShareiEpisodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason FosterConnect with Jun Yung Woo:LinkedIn: www.linkedin.com/in/junyungwooAGEM Bio website: www.agem.bioEmail: yung@agem.bioSupport the show

In this episode of Denatured, you'll hear from Jack Crawford, CEO of Demetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsJack Crawford, CEO, DemeetraMagnus Gustafsson, Chief Commercial Officer, NorthX BiologicsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Medical cannabis producers face costly licensing delays from overlooked GMP standards in lab design. Cleanroom engineering failures, poor ventilation, and documentation gaps are the pharmaceutical-grade pitfalls that derail facilities — and proper planning from day one prevents them. To learn more, visit https://hempirelabs.com/ Hempire Labs S.L. City: Sotogrande Address: C.C., Mar y Sol Local 3.9 Website: https://hempirelabs.com

Watch the show on television by downloading the e360tv channel app to your Roku, LG or AmazonFireTV. You can also see it on YouTube.Devin: What is your superpower?Deepti: The ability to rise after setbacks and turn challenges into opportunities.Billions of toothpaste tubes end up in landfills every year, creating an environmental burden that's hard to ignore. Recognizing this, Deepti Brambl, Founder of Kaylaan, developed an innovative alternative: toothpaste tablets. The eco-friendly product eliminates the need for plastic packaging while providing a healthier, more sustainable oral care solution.“Toothpaste tablets are not a new concept,” Deepti explained in today's episode, “but for me, it was important to come up with a solution that is not just plastic-friendly but also chemical-free. All of our products are natural, which ties back to how I was raised.”Kaylaan has also expanded into mouthwash tablets and patented bamboo electric toothbrushes, solidifying their commitment to green innovation. The toothbrushes, with recycled plastic handles to combat mold growth, are fully compostable striking the balance between sustainability and practicality.This eco-conscious ethos stems from Deepti's Nepalese heritage, where everything was reused. After moving to the U.S., she was struck by the plastic waste culture and wanted to create an alternative that redefined oral care. She started small, testing products on Etsy. Her toothpaste tablets stood out, quickly becoming a bestseller thanks to community feedback.The company's community-centered approach is evident in the evolution of their product line, including fluoride-based formulas, strawberry- and watermelon-flavored tablets for kids, and neem-based tablets. Customers' input continues to shape Kaylaan's innovations: “Whoever came to us with requests, we worked on it,” Deepti noted.In just a few years, Kaylaan has earned B Corp certification twice, reflecting its strong commitment to sustainability. Revenue from crowdfunding has been instrumental in scaling operations. Deepti highlighted how funds from a $45,000 raise helped move the company into a new facility, upgrade machines, and achieve compliance with FDA and GMP protocols.Currently, Kaylaan is raising capital through regulated investment crowdfunding on Honeycomb Credit. This presents an exciting opportunity for sustainability-minded investors to support Deepti's vision of redefining oral care.Deepti's journey exemplifies the power of mission-driven innovation. By tackling environmental challenges head-on, Kaylaan is demonstrating how purpose and profitability can coexist in harmony.tl;dr:Kaylaan develops eco-friendly toothpaste tablets to reduce waste and promote sustainable dental care.Deepti Brambl draws inspiration from her Nepalese heritage to drive innovation at Kaylaan.Crowdfunding on Honeycomb Credit has empowered Kaylaan to scale operations and achieve regulatory compliance.Customer feedback has shaped Kaylaan's diverse products, including fluoride-based and neem-flavored options.Deepti's resilience and passion for sustainability have propelled Kaylaan's mission to new heights.How to Develop Resilience As a SuperpowerDeepti's superpower is resilience—the ability to rise after setbacks and turn challenges into opportunities. She explained, “You fall as many times as possible, because that's where real creativity, real strength, and real learning happen.” Her perseverance fuels Kaylaan, as Deepti embraces obstacles as steppingstones for growth, strength, and creativity.Deepti vividly recounted the 10-hour ordeal of relocating a 5,000-pound tablet-press machine to a new manufacturing facility. After renting a forklift that couldn't manage the task, she worked with a team of local professionals to resolve the situation. Despite setbacks, her persistence resulted in more efficient production and significant quality improvements for Kaylaan's products.Tips to Develop Resilience:View challenges as opportunities for creativity and growth.Accept failure as part of learning and keep moving forward.Build strong community and business relationships for support during tough circumstances.Prioritize preparation upfront to avoid costly mistakes later.Embrace the idea that obstacles are a pathway to innovation and strength.By following Deepti's example and advice, you can make resilience a skill. With practice and effort, you could make it a superpower that enables you to do more good in the world.Remember, however, that research into success suggests that building on your own superpowers is more important than creating new ones or overcoming weaknesses. You do you!Guest ProfileDeepti Brambl (she/her):Founder, KaylaanAbout Kaylaan: We make oral care better for people and the planet. Our toothpaste tablets eliminate plastic tube waste, reduce water consumption, and deliver clinically effective results — proof that a daily habit as simple as brushing your teeth can be part of a more sustainable world.Website: kaylaan.comCompany Facebook Page: facebook.com/kaylaantoothpasteCompany Twitter Handle: @KaylaanTabsInstagram Handle: @kaylaantoothpasteOther URL: invest.honeycombcredit.com/campaigns/Kaylaan-2Biographical Information: Deepti Brambl, originally from the Himalayas, is the founder and lead engineer behind Kaylaan, a B Corp‑certified sustainable oral care company based in New York. Deepti has been featured in publications like Happi Magazine, Long Island Press, CanvasRebel, and on the “Founders, Unfiltered” podcast. On the Happi Podcast, she discussed Kaylaan's innovative approach to oral care and eco-packaging, positioning the brand at the intersection of sustainability and consumer convenience.LinkedIn Profile: linkedin.com/in/deeptibramblSupport Our SponsorsOur generous sponsors make our work possible, serving impact investors, social entrepreneurs, community builders and diverse founders. Today's advertisers include Fureelz, High Desert Gear, and Climatize. Learn more about advertising with us here.Max-Impact Members(We're grateful for every one of these community champions who make this work possible.)Brian Christie, Brainsy | Cameron Neil, Lend For Good | Carol Fineagan, Independent Consultant | Hiten Sonpal, RISE Robotics | John Berlet, CORE Tax Deeds, LLC. | Justin Starbird, The Aebli Group | Lory Moore, Lory Moore Law | Marcia Brinton, High Desert Gear | Mark Grimes, Networked Enterprise Development | Matthew Mead, Hempitecture | Michael Pratt, Qnetic | Mike Babbit | Coledger Solutions | Mike Green, Envirosult | Nick Degnan, Unlimit Ventures | Dr. Nicole Paulk, Siren Biotechnology | Paul Lovejoy, Stakeholder Enterprise | Pearl Wright, Global Changemaker | Scott Thorpe, Philanthropist | Sharon Samjitsingh, Health Care Originals | Add Your Name HereUpcoming SuperCrowd Event CalendarIf a location is not noted, the events below are virtual.How to Score the Economic Health of Your Community: On Friday, June 26th at 9:00 AM Pacific Time, we'll share a recording of a brilliant webinar led by Michael Shuman, publisher of the Main Street Journal, hosted by Jen Risley of AMIBA. You can watch it when it plays on SuperCrowd.tv. Download and install the app to your Roku or Amazon Fire TV device in advance!Join the SuperCrowd Impact League! You can be recognized for making impact investments via Reg CF. See how your activity compares to your peers. It's free. Win valuable prizes. Start now!SuperCrowd Impact Member Networking Session: Impact (and, of course, Max-Impact) Members of the SuperCrowd are invited to a private networking session on July 14th at 8:00 PM ET/5:00 PM PT. Mark your calendar. We'll send private emails to Impact Members with registration details. Upgrade to Impact Membership today!SuperCrowdHour, July 15, 2026, at 12:00 PM Eastern. Devin Thorpe, CEO and Founder of The Super Crowd, Inc., will lead a session on “How to Make a Splash With Your Campaign Launch.” Drawing on his extensive experience helping entrepreneurs and impact-driven founders succeed in investment crowdfunding, Devin will share proven strategies for creating momentum and attracting attention when launching a crowdfunding campaign. In this session, he'll explore how founders can prepare for a successful launch, build excitement before going live, engage their networks effectively, and generate the early traction that often determines long-term campaign success. Attendees will learn practical tactics for storytelling, outreach, media engagement, and community building, along with common mistakes that can limit visibility and investor interest. Whether you're preparing for your first crowdfunding raise or looking to improve the performance of a future campaign, this SuperCrowdHour will provide actionable insights to help you launch with confidence and maximize your campaign's impact from day one. Register now!SuperCrowd26 featuring PurposeBuilt100™: This August 25–27, founders, investors, and ecosystem leaders will gather for a three-day, broadcast-quality global experience focused on disciplined capital formation, regulated investment crowdfunding, and purpose-driven growth. We're bringing together leading voices in impact investing, compliance, digital marketing, and circular economy innovation to deliver practical frameworks, real-world case studies, and actionable strategies. The event culminates in the PurposeBuilt100™ Showcase, recognizing 100 of the fastest-growing purpose-driven companies in the U.S. Register now to secure your seat and get all the details. August 25–27, streaming worldwide.Share the application for the PurposeBuilt100™: Purpose-driven founders deserve recognition. The PurposeBuilt100™ application window is now open—celebrating the fastest-growing companies building profit with purpose. If you know a founder creating real impact and real growth, please share this opportunity. Applications are free and confidential. Explore the program and apply today: PurposeBuilt100.com.Community Event CalendarSuccessful Funding with Karl Dakin, Tuesdays at 10:00 AM ET - Click on Events.Register Now! October 20th and 21st will be the Crowdfunding Professional Association Regulated Investment Crowdfunding Summit for 2026. This is the event of the year for everyone in the crowdfunding ecosystem.If you would like to submit an event for us to share with the 10,000+ changemakers, investors and entrepreneurs who are members of the SuperCrowd, click here.Manage the volume of emails you receive from us by clicking here.We share educational information—not investment advice. Some links may generate compensation. See our full disclosure.We use AI to help us write compelling recaps of each episode. Get full access to Superpowers for Good at www.superpowers4good.com/subscribe

Nitric Oxide Explained: Vascular Health, Exercise Performance, and N1o1 with Dr. Nathan Bryan, international Leader in Molecular Medicine, the first to describe nitrite and nitrate as indispensable nutrients required for optimal cardiovascular health. He details NO as a ubiquitous messenger affecting blood flow, erectile function, cognition, exercise performance, endothelial dysfunction, and aging-related declines in NO production. Bryan explains why PDE5 inhibitors like Viagra prolong cyclic GMP signaling but don't fix NO deficiency, and why beet products often fail due to variable nitrate content and inadequate dosing. He outlines his NO lozenge approach that generates NO gas from sodium nitrite and magnesium ascorbate, plus a fermented beet powder drink (NOBeets), and emphasizes the role of oral bacteria (and harms of antiseptic mouthwash/fluoride) in nitrate conversion. They review published endpoints, including flow-mediated dilation, blood pressure effects, inflammation markers, triglycerides, stem cells, plaque regression, applications to Alzheimer's, glaucoma/microvascular disease, safety/dosing considerations, risks of arginine supplementation, and a dual-chamber topical NO serum developed from wound-healing experience.

This week, JP sits down with Harry and Chase from Umami Seed Co, one of the most respected names in modern cannabis breeding.Known for their relentless pursuit of flavor, elite genetics, and innovative breeding projects, Umami has become a global force in cannabis. From legendary pheno hunts to cutting-edge tissue culture programs, they're pushing the boundaries of what's possible in modern cannabis cultivation.One of the most fascinating parts of this conversation is Umami's exclusive Terp Tester Program—a worldwide network of over 250 growers helping test genetics in every environment imaginable. Every strain is distributed under a coded name and isn't officially released until growers submit detailed grow logs and feedback. With over 2,000 applications during the last round of testing, the demand to be part of the program continues to grow.

Recorded live from ICBC Berlin, Charles Warner sits down with Steve Fuhr of SciPhy Systems to discuss one of the hottest topics in the global cannabis industry: EU GMP compliance. Steve shares insights from his journey through cannabis cultivation, CBD manufacturing, and extraction technology while explaining why GMP standards are becoming increasingly important for companies looking to compete in international markets. The conversation explores the differences between North American GMP and EU GMP, the realities of cannabis market cycles, the future of hemp beyond CBD, and how emerging extraction technologies are reshaping the industry. They also dive into price compression, pharmaceutical cannabis applications, and why businesses need to prepare now for a more regulated future.

Recorded live at ICBC Berlin 2026, Chuck Warner sits down with Michael Lucchino, Executive Vice President of Sales at Cannatrol, to discuss one of the most overlooked yet critical stages of cannabis cultivation: post-harvest processing. While cultivators often focus heavily on genetics, lighting, nutrients, and environmental controls, Michael explains why drying, curing, and storage can ultimately determine product quality, consistency, shelf life, and profitability. The conversation explores Cannatrol's origins in artisanal food preservation, the science of vapor pressure control, the growing importance of GMP compliance in global cannabis markets, and how precision-controlled curing can improve everything from flower quality to pre-roll manufacturing efficiency. Whether you're a commercial cultivator, processor, cannabis entrepreneur, or simply interested in the science behind premium cannabis products, this episode offers valuable insights into how technology is transforming the industry's post-harvest workflow.

Why is cannabis research so much harder than researching other medicines?Dr. Lauren Kelly—Associate Professor at the University of Manitoba, Cannabis researcher and Trialist, CCIC President, and CMCN Co-Lead—joins Reefer MEDness to explain why cannabis clinical trials face unique barriers in Canada. Learn how Health Canada regulations, GMP vs GPP standards, product consistency challenges, and gaps in the Cannabis Act affect research, patient care, and evidence generation.Discover why researchers often can't study the same cannabis products patients actually use, how clinical trials begin from real-world observations, and what Canada can do to become a global leader in cannabis science.Listen now to understand the hidden challenges behind cannabis research and the future of evidence-based medical cannabis.Dr. Lauren Kelly - LinkedIn-University of ManitobaCanadian Medical Cannabis Trials Network - CMCN -WebsiteCanadian Consortium for the Investigation of Cannabinoids - WebsiteTranscripts, papers and so much more at: reefermed.ca

GMP! is taking a summer break, keep up with the big developments at www.theportugalclub.comGood Morning Portugal!

In this episode of SCW for Pharma, Evren Ozkaya welcomes Rajeev Kumar, Vice President at Biological E. Limited, a leading vaccine manufacturer and CDMO. Drawing on nearly three decades of experience across pharmaceutical manufacturing, supply chain management, and digital excellence, Rajeev shares his perspective on the evolution of the Indian pharmaceutical industry and the growing importance of quality, compliance, and digitalization.The conversation begins with Rajeev reflecting on how pharmaceutical manufacturing has changed since he entered the industry in the late 1990s. He explains that early pharmaceutical production focused heavily on antibiotics and APIs, where processes were comparatively straightforward and compliance requirements were less demanding. As the industry shifted toward vaccines, biologics, and other complex therapies, manufacturers faced significantly greater expectations around batch validation, data integrity, and audit readiness.Evren and Rajeev then explore the competitive advantages that have helped India become a global pharmaceutical powerhouse. While lower labor costs and large-scale manufacturing capabilities have historically contributed to India's success, Rajeev argues that the industry's strength today extends beyond cost leadership. He highlights India's growing expertise in producing complex biologics and vaccines at scale, supported by a highly skilled workforce and strong engineering capabilities.The discussion then turns to digital transformation and its role in improving productivity and reducing manufacturing costs. Rajeev explains that for advanced products such as mRNA vaccines and biologics, reproducible processes are essential. Monitoring yield, quality, and operational performance in real time requires digital technologies that support consistent execution and data-driven decision-making. He notes that while India continues to maintain cost advantages, future competitiveness will increasingly depend on talent, innovation, and manufacturing excellence.In the second half of the conversation, Rajeev provides a practical introduction to ALCOA+, one of the foundational frameworks for pharmaceutical data integrity. He explains the principles of Attributable, Legible, Contemporaneous, Original, and Accurate data, along with the additional requirements that data must be Complete, Consistent, Enduring, and Available. Rajeev demonstrates how technologies such as electronic batch records, digital logbooks, e-signatures, automated data collection, IoT connectivity, and cloud-based systems help manufacturers satisfy these requirements while improving operational efficiency.The discussion highlights an important connection between compliance and productivity. Rajeev explains that high-quality, automated data not only supports regulatory requirements but also enables better decision-making across manufacturing operations. As a result, investments in digital technologies often create benefits that extend far beyond compliance alone.Finally, Evren and Rajeev examine the future of digitalization in pharmaceutical manufacturing. While many companies still rely heavily on paper-based processes, Rajeev believes manufacturers must adopt digital transformation strategies that align with their level of digital maturity. Looking ahead, he suggests that as regulatory expectations continue to evolve, technologies such as digital logbooks and electronic batch records may become increasingly necessary—and potentially mandatory—for maintaining compliance and meeting future GMP requirements.Evren and Rajeev conclude their insightful conversation by emphasizing that quality, compliance, and digital transformation are becoming inseparable. As pharmaceutical manufacturing continues to advance toward more complex therapies, organizations that combine strong data integrity practices with modern digital technologies will be best positioned to achieve both regulatory excellence and operational performance.

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

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

Carl Munson announces a significant transition for his long-running platform, Good Morning Portugal!, as he moves away from daily live streaming toward new digital ventures. Reflecting on his extensive career as a leading content creator for the English-speaking expat community, Munson highlights how Artificial Intelligence and shifting migration trends have transformed the landscape since 2020.His future plans include the launch of Portugal Talk Radio, a 24/7 internet station designed to provide interactive audio content and community discussions.Additionally, he intends to conduct a feasibility study for a foreigners' association to offer better diplomatic representation and social integration for international residents.Google Notebook analyesed his "end of term" broadcast, which serves as both a retrospective of his prolific media output and a visionary outlook for fostering deeper connections within the country, and you can hear 'their' 'thoughts' on this recording.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

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.  

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

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

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

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.

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.

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

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