Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

What's the secret to turning a cutting-edge scientific breakthrough into a commercial biotech success?For every inspiring lab discovery, countless prototypes stall before ever reaching the market. The barriers? Securing the right beta testers, outmanoeuvring industry giants, and building teams who understand not just the science, but the user experience from bench to bedside.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann welcomes Chervee Ho, CEO & Co-Founder of BioChromatographix International. Chervee isn't just developing breakthrough column technologies - she's navigating the trenches of commercialization, from resource-stretched startups to partnering with risk-averse manufacturers. With hands-on experience turning innovative science into robust data and real-world adoption, Chervee shares candid lessons from her journey building a biotech company from the ground up.Here are three reasons you can't miss this episode:From Lab Bench to Market: Learn why finding the right beta testing partner is less about luck and more about networking, shared goals, and mutual resource investment - and why a methodical, step-by-step approach beats wishful thinking every time.Winning Against the Big Players: Discover how niche focus, third-party validation, and scientific partnership allow startups like BioChromatographix International to carve out space - even when competing against chromatography industry giants.The Human Factor: Chervee reveals why startup success is all about mindset - resilience, adaptability, and startup “muscle” - far more than specific credentials. If you want to build a team ready for the marathon of commercialization, don't miss these culture insights.Ready to level up your biotech commercialization strategy? Tune in and hear how to accelerate your technology from concept to clinic - without losing focus, funds, or your sanity.Connect with Chervee Ho:LinkedIn: www.linkedin.com/in/cherveehoWebsite: www.biochromatographix.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

Every year, cutting-edge biomedical technologies are left stranded in the lab, not for lack of innovation, but because they miss the crucial leap from technical performance to genuine industry adoption. The gap between scientific brilliance and commercial success is deceptively simple: deeply understanding and building for your customer's real-world pain points.In this episode, David Brühlmann welcomes Chervee Ho, CEO & Co-Founder of BioChromatographix International. With a background at the intersection of biotechnology and commercial strategy, Chervee has helped reshape how startups approach product development to actually get adopted in conservative markets. From her early days in biotech to launching Singapore's next-generation monolithic chromatography company, Chervee advocates for honest conversations, real customer feedback, and an unflinching commitment to building solutions that people want - not just what scientists think they need.Here are three reasons you can't afford to miss this conversation:Commercial Thinking from Day One: Technical superiority is just the start; Chervee reveals how embedding commercial strategy from the earliest stages, long before the product is ‘perfect', ensures your innovation will actually be used. Start with end-user needs and map backward.Designing for Adoption, Not Just Performance: Don't fall in love with your tech. Discover how BioChromatographix adopted a customer-centric “design for adoption” approach, integrating products into current workflows, minimizing disruption, and collecting real-life feedback that shaped commercial-ready solutions.Bridging the Science-to-Market Divide: Learn how continuous customer engagement, ruthless validation of pain points, and smart use of public data (even while protecting IP) can transform a great idea into a market-ready, trust-building product.Ready to close the gap between invention and adoption? Tune in to discover why commercial thinking isn't just for the sales team and how it's the secret weapon for any biotech scientist wanting to make a lasting impact.Don't just innovate - get your technology into the hands of those who need it most.Connect with Chervee Ho:LinkedIn: www.linkedin.com/in/cherveehoWebsite: www.biochromatographix.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

What if the secret to making continuous bioprocessing practical, sustainable, and far simpler has been shaking - literally - just beneath our feet?For years, the industry has grappled with the complexities of continuous manufacturing, with technologies like ATF (alternating tangential flow) steadily dominating the perfusion landscape. But what if there's a game-changer right around the corner - a technology that vibrates membranes, not workflows, promising both higher performance and a greener footprint?Enter Jarno Robin, a pioneering force in membrane filtration and Pharma Business Development Director at Sani Membranes. With two decades of experience implementing ATF and championing continuous innovation in bioprocessing, Jarno isn't just speculating about change—he's building it. In this episode, host David Brühlmann gets hands-on with Jarno as they unpack Sani's patented Vibro Membrane Filtration (VMF) technology and its bold promise to transform upstream and downstream bioprocessing.Here are three reasons you can't afford to miss this conversation:Vibration Over Crossflow: Sani's VMF system shakes up conventional wisdom by using vibration to generate turbulence, achieving uniform transmembrane pressure, reducing cell damage, and enabling robust, scalable separations across applications from mAbs to cultivated meat and even challenging mRNA workflows.Seamless Tech Swap (and Sustainability): Transitioning from ATF or TFF to VMF? Jarno explains how the setup is surprisingly straightforward, requires fewer connections at scale, dramatically cuts chemical use, and can slash your environmental footprint, as membranes last years instead of months.Innovation Demands Resilience: Beyond equipment specs, Jarno pulls back the curtain on what it really takes to drive innovation in pharma: relentless belief, hours of extra work, and the patience to let good data - and internal advocates - build momentum for change.Ready to see bioprocessing through a new lens? Tune in to discover how vibrating membranes may help you simplify your CMC development pipeline, reduce waste, and position your organization for a more continuous, efficient future.Connect with Jarno Robin:LinkedIn: www.linkedin.com/in/jarno-robinWebsite: www.sanimembranes.comCurious about continuous processing challenges and breakthroughs? Don't miss these previous episodes.Episodes 39-40: Balancing Perfusion Process Development and Sustainability with Jochen SieckEpisodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

What if one of biotech's biggest production breakthroughs was hiding in plain sight? Not in a new gene or a wonder drug, but in the way we process and purify biologics.Perfusion technology, once dismissed as a pipedream in top biopharma boardrooms, is now quietly powering some of the industry's most efficient and productive manufacturing platforms. Yet, transforming perfusion from controversial buzzword to gold standard required timing, vision, and a willingness to break from tradition.In this episode, host David Brühlmann sits down with Jarno Robin, a bioprocessing pioneer whose 20+ year journey spans industry giants like Novo Nordisk, Sanofi, and Leo Pharma. Jarno has championed upstream continuous processes, including ATF and TFF, for decades, and now, as a leader at Sani Membranes, he's unleashing the next evolution: Vibro® Membrane Filtration, an innovation set to upend conventional wisdom about fouling, pressure loss, scalability, energy usage, and more.Here are three reasons you'll want to listen to Jarno's journey:Innovation Versus Industry Inertia: Behind every platform shift are years of resistance. Jarno recounts how timing, advocacy, and matching the right data with the right decision-makers finally made perfusion mainstream, even after company leaders proclaimed, “We will never ever run perfusion.”State-of-the-Art and the Next Frontier: ATF and TFF remain dominant, but their limitations, like membrane fouling, scale-up headaches, and high energy needs, are real. Jarno explains how Vibro® Membrane Filtration addresses these pain points with a radically new design, offering lower pressure loss, less fouling, higher cell densities, and surprisingly low energy consumption.Practical Wisdom for Bioprocess Developers: Should you always run a control in process development? How do you translate lab-scale wins to robust, money-earning production? Jarno shares counterintuitive advice based on decades of hands-on success and mistakes.Curious how you can optimize your process technology and sidestep costly pitfalls? Listen to this episode and discover how “timing is everything” in bioprocessing innovation and whether new filtration methods could help you leap ahead.Connect with Jarno Robin:LinkedIn: www.linkedin.com/in/jarno-robinWebsite: www.sanimembranes.comCurious about continuous processing challenges and breakthroughs? Don't miss these previous episodes.Episodes 39-40: Balancing Perfusion Process Development and Sustainability with Jochen SieckEpisodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

The promise of advanced cell therapies is undeniable, but as demand skyrockets, the challenges of taking a living drug from bench to bedside have never been greater. Each batch brings variability, each jurisdiction adds regulatory hurdles, and every strategic decision can determine whether a lifesaving therapy reaches patients or fizzles out behind clinical barriers.Lindsay Davies is a leading figure in the cell and gene therapy field, serving as Vice President-Elect for Europe at the International Society of Cell and Gene Therapy (ISCT). She is Chief Scientific Officer at NextCell Pharma, co-founder of QVance, and founder of the consultancy CellTherEx. With over 20 years of experience across academia and industry, she brings deep expertise in MSC manufacturing, process development, and commercialization of advanced therapies. Here are three reasons this episode is a must-listen:Manufacturing at Scale, Without Compromise: Lindsay shares why NextCell Pharma has stuck with large-scale 2D manufacturing for MSCs, leveraging cell morphology and a patented donor selection algorithm to reduce batch-to-batch variability while maximizing reproducibility and safety, even when treating hundreds from a single batch.Smart Scaling: Up, Out, or Both? The debate isn't just academic. Lindsay explores when it makes sense to scale up processes versus scaling out to multiple manufacturing sites. She highlights how harmonizing global regulatory expectations and moving to closed 2D systems can lower costs, de-risk production, and bring life-changing therapies to more patients worldwide.Network or Nowhere: Lindsay calls out the myth of the lone innovator, championing the crucial role of strategic networking, partnership models, including “sweat equity”, and early regulatory engagement as keys to avoiding the common commercialization pitfalls that stall so many promising ATMPs.Wondering how to navigate the twin challenges of process control and commercial viability in ATMP development? This episode offers a rare, candid roadmap from the front lines.Connect with Lindsay Davis:LinkedIn: www.linkedin.com/in/lindsay-c-daviesWebsite: www.nextcellpharma.comIf you're interested in breakthroughs in cell therapy, here's what some of our previous guests have shared from the front lines of innovation:Episodes 105-106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayEpisodes 125-126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon ShareiNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

The key to conquering autoimmune diseases and type 1 diabetes may lie not in replacing lost cells, but in retraining the immune system using cells already within the body.Biotech is increasingly exploring stem cell therapies, but a quieter revolution is brewing: stromal cell therapy. These master “coordinators” aren't about rebuilding tissues molecule by molecule - instead, they orchestrate an anti-inflammatory response, offering new hope for conditions once considered incurable.In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Lindsay Davies, a leading expert in advanced therapies. She is the CSO at NextCell Pharma, consultant at CellTherEx, and co-founder of QVance, a QC analytics provider for ATMPs. Recently elected Vice President Elect for Europe at ISCT, Lindsay also chairs its European Industry Committee and serves on multiple task forces. With over 20 years bridging academia and industry, she's helped shape the full lifecycle of cell-based therapies, from development to commercialization.Here are three reasons why you can't miss this episode:Stromal Cells - The Unsung Heroes: Discover the essential distinction between stem cells (the “builders”) and stromal cells (the “coordinators”), and how harnessing the latter's unique immune-modulatory powers is unlocking treatments for diabetes, COVID-19, and autoimmune diseases.A Manufacturing Mindset Shift: Lindsay explains why scaling out cell therapies defies the “plug-and-play” approaches of traditional biologics manufacturing. With cell quality so sensitive to environmental shifts, the key lies in process simplicity, early regulatory collaboration, and deep biological understanding - especially when donor variability enters the mix.Allogeneic Therapies Made Real: Thanks to umbilical cord-derived stromal cells, treatments can be manufactured at scale, stored frozen, and delivered on demand - no patient matching required. The result? Outpatient infusions, no side effects, and effects lasting up to five years, dramatically simplifying lives for those with chronic inflammatory conditions.Ready to rethink how cell therapies are changing medicine - and what it could mean for your bioprocessing strategy? Hit play and find out how Lindsay Davis is redefining what's possible in advanced therapy manufacturing.Connect with Lindsay Davis:LinkedIn: www.linkedin.com/in/lindsay-c-daviesWebsite: www.nextcellpharma.comIf you're interested in breakthroughs in cell therapy, here's what some of our previous guests have shared from the front lines of innovation:Episodes 105-106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier DetournayEpisodes 125-126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon ShareiNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest anJoin 500+ CGT leaders at Advanced Therapies Europe 2025 (September 2-4, Barcelona) for live case studies, regulatory insights, and exclusive collaboration opportunities. As a Smart Biotech Scientist listeners you'll save 20% with code SMARTPODCAST20 – Register hereSupport the show

The promise of cultured food is undeniable: delicious, sustainable meat and fish grown without the need for traditional farming. But the journey from lab bench to supermarket shelf is filled with complex regulatory, technological, and consumer acceptance challenges. The big question: how do we transform small-scale breakthroughs into global food production realities?In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann sits down with Richard Alldread, CTO of The Cultured Hub - a unique joint venture between Givaudan, Bühler, and Migros - positioned at the intersection of flavor, food processing, and retail expertise.Richard Alldread has led process and technology development across the biopharmaceutical sector, with roles at major biotech corporations and brings decades of experience from the biopharma world into the food tech sphere, helping innovative startups bridge the gap from promising lab results to economically and technically scalable food products.Here are three reasons to keep listening:Scaling Up, Not Just Out: Richard exposes why many food startups stumble: overly complex, non-scalable processes and the misapplication of biopharma's single-use equipment. Instead, the food industry is reigniting interest in robust stainless steel facilities to meet the vastly greater scale and lower margins of food versus pharma.From Bench to Market: The Cultured Hub isn't just about tanks and tech; it's a one-stop shop where startups gain hands-on access to commercial-scale bioreactors, regulatory expertise, and direct links to the whole value chain, from flavor development to supermarket shelves.Consumer Acceptance Is (Still) King: No matter how flawless the process or affordable the meat, Richard emphasizes that success hinges on consumer adoption. The industry's greatest test isn't technological, it's shifting perceptions of cultured foods to turn curiosity into routine repeat purchases.Ready to hear what it really takes to transition cultured food from niche curiosity to supermarket staple? Dive into this episode and discover the hard truths, emerging solutions, and industry insights driving the next food revolution.Connect with Richard Alldread:LinkedIn: www.linkedin.com/in/richard-alldread-01923644Website: www.theculturedhub.comWant to hear more perspectives on the future of cell-based food? Don't miss these previous episodes:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangEpisodes 45-46: From Lab to Table: The Science Behind Cultivated Meat with Petra HangaEpisodes 15-16: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat ThalmannNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

What if the secrets to feeding the planet - and democratizing access to future protein - were hiding in the core toolkit of biopharma?The worlds of biopharmaceuticals and cultured food may seem galaxies apart, but at their heart, both rely on remarkably similar technology: media, bioreactors, and cell processing. Yet, as demand grows for sustainable, affordable protein for the masses, innovators are confronting a challenge bigger than scale.This week, host David Brühlmann welcomes Richard Alldread, Chief Technology Officer at The Cultured Hub, a groundbreaking joint venture between three Swiss industry leaders that specializes in developing and scaling cell culture processes for cultivated foods.Most of Richard's career has been dedicated to leading process and technology development initiatives within the biopharmaceutical industry. He has held key roles at major biotech organizations. He now leads the charge in applying high-tech bioprocessing to the ultimate scale-up: cultivated food. His journey from pioneering life-saving biologics to reimagining food production offers a rare insider's view of biotech's next frontier.Here are three reasons you can't miss this episode:Bioprocessing's Universal Blueprint: Richard breaks down the striking similarities between pharmaceuticals and food - media, bioreactors, sterility - but reveals why the economics and scale make cultivated food an entirely new beast.From Clinic to Kitchen: Discover how the shift from producing grams of life-saving drugs for the West to tons of affordable protein for global tables flips traditional priorities, pushing innovation in cost reduction, media development, and facility design.The Art of Keeping it Simple: Richard shares a contrarian philosophy: the best processes need fewer high-tech analytics, not more. He weighs in on where digital tools, modeling, and even AI fit into building robust, scalable bioprocesses for the food industry.Curious about how the lessons of biopharma might feed the world? Dive into this episode to uncover the biggest technical, economic, and biological hurdles - and why the next big leap in bioprocessing may end up on our dinner plates.Connect with Richard Alldread:LinkedIn: www.linkedin.com/in/richard-alldread-01923644Website: www.theculturedhub.comWant to hear more perspectives on the future of cell-based food? Don't miss these previous episodes:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangEpisodes 45-46: From Lab to Table: The Science Behind Cultivated Meat with Petra HangaEpisodes 15-16: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat ThalmannNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

What if the missing link to resilient European bioproduction is not just another breakthrough technology, but the ability to continuously learn, adapt, and collaborate?In a rapidly shifting biotech landscape, innovation isn't only driven by technical prowess. Behind every robust production process and every cutting-edge therapy, there's a team empowered with both technical expertise and the soft skills necessary to thrive.In this episode, host David Brühlmann explores the human side of bioproduction with Sandrine Lemoine, CEO of Immerscio.bio, who has dedicated her career to transforming talent development in the industry. Sandrine Lemoine brings a unique perspective to biotech training: as both an executive coach and a veteran of pharmaceutical leadership roles, she founded Immerscio.bio to bridge the gap between innovation and workforce development. Her work focuses on immersive, flexible training that prepares biotech professionals - new and experienced alike - for the evolving demands of modern bioproduction, keeping Europe's talent future-ready.Here are three reasons why you shouldn't miss this episode:Soft Skills as a Catalyst: Sandrine reveals why leadership, collaboration, and a “co-construction” approach are critical to effective innovation in bioproduction, not just as buzzwords, but as real drivers of successful project delivery.Continuous Learning as a Strategy: Discover how Immerscio.bio's adaptable training modules keep professionals ahead of the curve in a field defined by fast regulatory shifts, automation, and new therapies - arming teams for every transition, from immunology pivots to advanced manufacturing technologies.Resilience through Workforce Development: As Europe faces unprecedented talent shortages and global competition, Sandrine explains how investing in people and fostering a habit of lifelong learning is key to healthcare sovereignty and the industrialization of scientific progress.Ready to upgrade your own bioprocessing career or build a future-ready team? This conversation will inspire you to see training not as a checkbox, but as your greatest tool for impact in biotech.Connect with Sandrine Lemoine:LinkedIn: www.linkedin.com/in/sandrine-lemoine-ba244a58Website: https://immerscio.bioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development and manufacturing: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

What if the road to bioproduction mastery started not in the lab, but with how you train your people?Traditional biotech education often ends at theory, leaving graduates unprepared for the fast-paced world of manufacturing. But what if the key to faster, safer, and more scalable bioprocessing is digital immersion, letting scientists train in a virtual facility before they ever enter a real one?This week, David Brühlmann welcomes Sandrine Lemoine, CEO of Immerscio.bio, to the Smart Biotech Scientist Podcast. With over 25 years spanning R&D, manufacturing strategy, and executive coaching, Sandrine has seen firsthand the widening gap between academic training and the urgent needs of industry. Now, she's tackling the bioproduction talent shortage head-on through digital modules, built for skills, not just knowledge. From international team leadership to championing hands-on, immersive learning, Sandrine's mission is to future-proof the workforce our industry desperately needs.Here are three reasons you should queue up this episode:Immersive Digital Training Meets Industry Demand: Sandrine explains how 100% digital courses - leveraging 3D simulations, serious games, and virtual reality - are bridging the gap between academic theory and operational reality.Collaborating With Industry, Evolving With Technology: Immerscio.bio's modules aren't static. Developed by a consortium of major pharma and biotech companies, they're constantly updated through direct feedback and partnership to keep pace with ever-changing technology and regulations - ensuring every learner gains relevant, up-to-date skills.Beyond Technical Skills: Building the Right Mindset: Technical expertise alone won't cut it. Sandrine shares how soft skills like critical thinking, autonomy, and quality mindset are intentionally woven into training, preparing new hires and career-changers for the demands of a high-stakes, rapidly evolving field.Curious how digital and AI-supported training could accelerate your team's readiness and your career? Listen in to discover how Immerscio.bio is redefining workforce development, and get inspired to rethink your own approach to learning.Connect with Sandrine Lemoine:LinkedIn: www.linkedin.com/in/sandrine-lemoine-ba244a58Website: https://immerscio.bioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development and manufacturing: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

How do you transform hybrid model digital twins from promising lab concepts into commercial bioprocessing game-changers that actually deliver ROI?As biotech companies race to implement Industry 4.0 technologies, the critical challenge isn't just developing sophisticated hybrid models - it's deploying them strategically to create user-friendly, cost-effective solutions that genuinely accelerate your path to commercial bioprocessing success.In Part 2 of this essential conversation, David Brühlmann continues his deep dive with Krist Gernaey, Professor of Industrial Fermentation Technology at the Technical University of Denmark. Krist reveals the strategic framework for moving beyond digital twin hype to build hybrid modeling capabilities that scale from lab validation to commercial manufacturing reality.Three Strategic Insights for Commercial Implementation:Digital Twins That Deliver Business Value: Krist cuts through the marketing buzz to define what makes digital twins commercially viable - revealing why true value comes from two-way data exchange and predictive capabilities, not just virtual process copies. Learn the validation strategies that separate successful implementations from expensive pilot projects.Modular Strategy Over Technology Complexity: Forget the "silver bullet" mentality. Krist advocates for strategic building blocks: start with site comparisons and predictive maintenance, then systematically add hybrid modeling complexity as your organization develops the technical capacity and team skills for sustainable commercial success.User-Centric Models for Operational Excellence: The biggest commercial wins aren't always about optimizing yields - they're about creating transparency, robust documentation, and operator-friendly tools that reduce complexity rather than adding it. Discover how to design hybrid model digital twins that empower your manufacturing teams instead of overwhelming them.Ready to develop a strategic roadmap for implementing hybrid model digital twins that drive commercial bioprocessing success? Tune in for Krist's proven framework for avoiding "cauliflower complexity" while building sustainable digital transformation capabilities that scale.Connect with Krist Gernaey:LinkedIn: www.linkedin.com/in/krist-gernaey-591748Website: www.orbit.dtu.dk/en/persons/krist-v-gernaeyIf you're intrigued by the evolving frontier of bioprocessing, don't miss these enlightening episodes:Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 05-06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Are you struggling to bridge the gap between lab-scale models and commercial bioprocessing reality? For many biotech innovators, the promise of digital twins meets harsh industrial constraints - where hybrid models that excel in controlled lab environments must prove themselves in the complexity of large-scale manufacturing.This week on the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Krist Gernaey, Professor of Industrial Fermentation Technology at the Technical University of Denmark. With expertise spanning measurement technology development and two decades pioneering hybrid model digital twins for bioprocess applications, Krist reveals the critical gap between digitalization hype and industrial implementation reality.Here are three key reasons this episode will level up your hybrid modelling and digital twin approaches.From Data Overload to Intelligent Control: Raw sensor data means nothing without the right models to interpret it. Krist demonstrates how hybrid model digital twins convert complex bioprocess measurements into actionable control strategies - showing why sophisticated algorithms need simple, robust sensors to succeed at commercial scale.From Individual Genius to Team Implementation: The most elegant digital twin fails without operator buy-in. Krist shares why successful commercial bioprocessing depends on bridging academic innovation with frontline manufacturing expertise - revealing the human factors that make or break advanced modeling initiatives.From Lab Perfection to Commercial Pragmatism: Discover why the most promising hybrid modeling approaches must balance mechanistic understanding with data-driven adaptation. Krist provides a reality check on electrochemical sensors, validation challenges, and the strategic decisions that determine whether digital twins deliver commercial value or remain expensive experiments.Ready to master the art of scaling hybrid model digital twins from promising lab tools to commercial bioprocessing game-changers? Tune in to discover Krist Gernaey's battle-tested strategies for navigating the complex journey from academic innovation to industrial impact.Connect with Krist Gernaey:LinkedIn: www.linkedin.com/in/krist-gernaey-591748Website: www.orbit.dtu.dk/en/persons/krist-v-gernaeyIf you're intrigued by the evolving frontier of bioprocessing, don't miss these enlightening episodes:Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 05-06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Downstream processing remains one of the most complex and critical steps in biomanufacturing, especially as new therapeutic modalities like cell and gene therapies push current technologies to their limits. The industry faces ongoing pressure to innovate, reduce costs, and improve efficiency, while still ensuring robust and reliable results.In this practical, energetic episode, host David Brühlmann welcomes Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). With a career spanning continents - Asia, Europe, and North America - Scott's perspective is forged from hands-on manufacturing, technology transfer, and building high-growth companies from scratch. He's not just innovating the science behind chromatography; he's lived the manufacturing realities, spanning everything from precision antibodies to complex gene therapies, and now leads a team solving the tough purification puzzles holding progress back.Here are three reasons why this episode is a must-listen:Continuous Innovation in Chromatography: Despite a hundred-year legacy, chromatography still holds tremendous untapped potential, especially with new materials and continuous processing, as Scott highlighted with real examples from gene and cell therapy applications.Bridging Lab to Market Needs Customer Focus: Getting new technology into commercial use requires not just technical innovation, but deep user engagement, robust feedback loops, and iterative improvement, plus ongoing education to help users understand new benefits.Embrace Experimentation and Global Collaboration: Whether building companies in Asia, Europe, or the U.S., Scott reminds us that learning from failure, being open to international collaboration, and not being afraid to try new things are essential for long-term growth (and enjoying the biotech journey along the way!).If you're passionate about downstream processing, tech innovation, or just want to hear inspiring leadership lessons, check out the full episode and connect with Scott Wheelwright or visit the company's website to follow his team's advancements.Connect with Scott Wheelwright:LinkedIn: www.linkedin.com/in/scottmwheelwrightWebsite: www.biochromatographix.comCurious about chromatography? Tune in to hear what our previous guests had to say!Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 61-62: Magnetic Bead Technology: The New Era in Downstream Processing with Nils BrechmannEpisodes 37-38: How to Master Downstream: A Deep Dive Into Bioprocessing Purification with Wei ZhangNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

For decades, chromatographic purification has made use of bead-based diffusion - a reliable but limiting approach, especially as new modalities like gene therapies, mRNA, and viral vectors push the boundaries of what's possible. But what if the future of downstream processing lies not in incremental improvement, but in a dramatic reimagining - from slow diffusion to rapid convection?In this episode, David Brühlmann meets Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). Scott brings decades of expertise in biopharmaceutical development and manufacturing. Prior to BCI, he co-founded Biolnno Bioscience, a leading CDMO, and co-founded Innovent Biologics, one of China's foremost biotechnology companies.Here are three compelling reasons to tune into this episode:Breaking the Mold of Purification: BCI's AXISFLOW™ Platform moves beyond bead-based processes, using advanced 3D-printed monoliths that enable convective flow, making purification of large biomolecules and viruses faster, more efficient, and better suited for next-generation therapies.Innovation Starts with Imagination (and Measurement): True progress in bioprocessing often hinges not on what we can make, but on what we can accurately measure and imagine. Scott reminds us that advances in analytical testing and creative thinking are the real engines of change.Biotech Demands More than Great Science: Success isn't just about inventing; it's about building with the end-user in mind. Scott's journey highlights the critical role of customer-centric product development, cross-disciplinary teamwork, and regulatory strategy - especially in a conservative, risk-averse industry.Curious how shifting from diffusion to convection could reshape your purification workflow? Listen to this episode and discover how to unlock efficiency, cut costs, and deliver therapies that might otherwise remain out of reach.Connect with Scott Wheelwright:LinkedIn: www.linkedin.com/in/scottmwheelwrightWebsite: www.biochromatographix.comCurious about chromatography? Tune in to hear what our previous guests had to say!Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 61-62: Magnetic Bead Technology: The New Era in Downstream Processing with Nils BrechmannEpisodes 37-38: How to Master Downstream: A Deep Dive Into Bioprocessing Purification with Wei ZhangNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

For years, disease diagnosis and treatment have focused on a few biomarkers, overlooking thousands of vital biological signals. Despite biotech advances, most therapies are still based on limited data, missing countless breakthroughs.Multiomics changes that. By analyzing tens of thousands of proteins, metabolites, and lipids, it reveals hidden insights, paving the way for smarter, faster, and more effective medical discoveries.In this must-listen episode, David Brühlmann welcomes Mo Jain, founder and CSO of Sapient, a pioneering force in bringing multiomic platforms out of academia and into the heart of drug development. A physician-scientist by training and a visionary entrepreneur by choice, Mo's journey spans decades at the cutting edge of analytical technologies, culminating in the creation of ultra-high-throughput systems that analyze up to 20,000 biomarkers in a single run for real-world impact.Here are three reasons why this episode needs to be on your playlist:Multiomics at Scale: Mo shares how his team at Sapient turbocharged mass spectrometry, enabling simultaneous measurement of thousands of molecules, transforming routine diagnostics and making previously unimaginable insights accessible to scientists everywhere.Turning Data into Action: Generating vast data is only half the battle. Mo explains how Sapient developed advanced biocomputational teams and frameworks to extract actionable answers, guiding drug developers to faster, smarter decisions and helping avoid the pitfalls that cripple so many omics projects.The Future Is Personalized and Sooner Than You Think: From dramatically earlier disease detection to truly personalized therapies, Mo paints an optimistic picture of a coming era where AI, multiomics, and new therapeutic modalities rapidly accelerate both discovery and delivery, reshaping how biotech companies tackle even the toughest diseases.Ready to break out of the 20-biomarker rut and see what 20,000 data points can reveal? Tune in to discover how you can harness multiomics in your own research and hear Mo's advice for scientists and entrepreneurs venturing beyond the bench.Connect with Mo Jain:LinkedIn: www.linkedin.com/in/mo-jain-md-phd-373895baWebsite: www.sapient.bioCompany LinkedIn Page: https://www.linkedin.com/company/sapientbioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

What if the secret to truly personalized precision medicine lies not in your genetic code, but in your zip code?For years, biotech has focused on genomics to explain disease and drug response, but DNA only accounts for a fraction of the story. The real breakthrough? Multi-omics: the large-scale analysis of proteins, metabolites, and lipids, powered by advanced mass spectrometry and AI, offering a fuller picture of human health.In this episode, David Brühlmann meets Mo Jain, founder and CSO of Sapient, a leader in multi-omics analytics. With over two decades of experience across physiology, biomedicine, and computational biology, Mo has been at the forefront of developing scalable multi-omics technologies that are changing the way we predict, diagnose, and treat disease. From leading an academic lab to building a pioneering biotech company, Mo's journey reflects a passion for uncovering the hidden 80–90% of disease risk that lies beyond our genes.Here are three reasons you'll want to listen to this episode:Your Environment Matters More Than Your Genes: Mo explains why your zip code is a stronger predictor of your health than your genetic code, challenging the industry's long-held beliefs and opening new avenues for disease prevention and risk assessment.Multi-omics Disrupts Drug Development: Discover how integrating thousands of biological data points can revolutionize drug discovery by identifying novel targets, better predicting drug response, and accelerating therapeutic breakthroughs that were previously out of reach.Big Data Finally Becomes Actionable: Thanks to rapid advances in mass spectrometry and computational power, scientists can now make sense of overwhelming volumes of multi-omic data, turning what was once information overload into actionable insights for diagnostics and drug development.Ready to think beyond your genes? The biotech revolution is here, and it starts in your neighborhood.Connect with Mo Jain:LinkedIn: www.linkedin.com/in/mo-jain-md-phd-373895baWebsite: www.sapient.bioCompany LinkedIn Page: https://www.linkedin.com/company/sapientbioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

The promise of generative AI in pharma and biotech is huge, but it's also fraught with complexity, especially when it comes to integrating these systems into highly regulated environments. From monitoring evolving guidelines to balancing operational efficiency and data integrity, the journey from hype to real-world impact is filled with both opportunity and skepticism.In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck Healthcare's Global Analytical Development. Abhijeet has spent years on the front lines of digital transformation in the biotech sector, and his current mission: implementing generative AI for regulatory guideline monitoring, without giving the quality team a collective heart attack. He offers a no-nonsense roadmap for biotech leaders looking to streamline compliance, harness AI potential, and future-proof their operations.Here are three reasons you should hit play on this episode:From Proof of Concept to Real-World Implementation: Discover how Abhijeet's team moved beyond early excitement to tackle regulatory, IT, and data privacy requirements, carving a safe and compliant path for bringing generative AI tools into GxP and GMP-adjacent workflows.Human-in-the-Loop Isn't Optional: Learn why user training, prompt engineering, and close collaboration between scientists and AI are essential for extracting meaningful (and accurate) insights, especially in environments where routine and regulation reign supreme.ROI and Regulation - The Balancing Act: Hear candid perspectives on measuring the return on investment for new digital tools, addressing skeptics closer to manufacturing, and why the real game-changer might just be a community-driven, industry-wide approach to regulatory acceptance.Wondering how to unlock GenAI's full potential - or just avoid the common pitfalls? Dive into this episode for practical strategies, cautionary tales, and actionable insights from someone who's actually navigated the compliance minefield.Bring AI into your pipeline with confidence, clarity, and compliance.Connect with Abhijeet Satwekar:LinkedIn: https://www.linkedin.com/in/abhijeetsatwekarNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Ever feel like you're drowning in an ocean of constantly shifting regulatory guidelines? The world of biotech is a whirlwind of evolving standards, making compliance not just a headache, but sometimes the stumbling block between life-changing therapies and the patients who need them. But what if artificial intelligence could turn regulatory chaos into your biggest competitive advantage?In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck KGaA's Global Analytical Development. Abhijeet shares how he's pioneering the use of generative AI, not as a hype machine, but as a practical, transformative tool for regulatory compliance in biotech. With over a decade navigating analytics, digitalization, and collaborative tech adoption at a major pharma leader, Abhijeet knows what it takes to connect industry stakeholders, harness new technologies, and turn business operations into streamlined, value-generating systems.Here are three reasons you won't want to miss this episode:Generative AI as a Compliance Powerhouse: Discover how AI is being harnessed to analyze, extract, and compare complex regulatory requirements across different countries, cutting through ambiguous language and shifting specifications - so you don't have to.Reducing Regulatory Bottlenecks: The days of manually reconciling guideline documents and updating baselines with every regulatory change are numbered. Learn how generative AI accelerates multi-guideline comparison, saving teams countless hours and reducing the risk of costly errors and delays.A Blueprint for Digital Transformation: Abhijeet reveals how Merck is moving from proof-of-concept to operational reality, building collaborative teams that bridge IT, analytics, regulatory, and quality to bring valuable digital tools into daily practice.Curious if your team could automate away regulatory headaches? Listen in and get inspired to tackle your toughest compliance challenges - before your competitors do.Connect with Abhijeet Satwekar:LinkedIn: https://www.linkedin.com/in/abhijeetsatwekarNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Have you ever presented a major scientific breakthrough, only to be met with blank stares and distracted executives? You're not alone. In this episode, David Brühlmann shares how he went from drowning in data to winning an innovation contest, not through better tech, but through the power of scientific storytelling.Many scientists default to methods and data, but as David notes, “it's like being fluent in a language nobody else in the room speaks.” Without a clear link to human impact, even the most brilliant work can go unnoticed.Key insights from the episode that could transform your next presentation:The Three-Act Structure: Storytelling That Resonates - David shows how Apple's iPhone launch used this classic structure, and how scientists can do the same. Start with “why” (impact), then move to “how” (the science) to keep your audience engaged without losing rigor.Turning Your Audience Into the Hero: Adapting Donald Miller's framework, David flips the script: your audience is the hero, and your innovation is their guide. It's about speaking to their needs, not just showcasing your work.Why Storytelling Works: The Neuroscience Edge: Stories release dopamine (focus), oxytocin (trust), and endorphins (emotion) - activating how we naturally learn and remember. It's not fluff; it's brain science.Decision-makers won't remember your chromatogram, but they will remember the story and its impact. The real test of your pitch? Whether it drives action: follow-up meetings or funding.You don't need to simplify your science. You need to spotlight what matters most to your audience. With a strong narrative, your work stops being overlooked potential and starts becoming real-world impact.Ready to revolutionize your next presentation? Lean into the power of storytelling - your data, your career, and the lives you touch will thank you.Listen to the full episode to explore the straightforward storytelling structure David uses to bring scientific ideas to life.

Have you ever poured months of research into a brilliant innovation, only to watch executives' eyes glaze over during your presentation? You're not alone. In this episode, host David Brühlmann describes a familiar frustration: scientists are trained to perfect data, not to sell ideas. But in today's fast-paced biotech landscape, even the most groundbreaking technology risks fading into obscurity if it isn't communicated effectively.Here's what you'll learn in this episode:Why Good Science Needs Great Storytelling: David Brühlmann shows that the most funded projects are often the best-communicated, because even experts remember stories, not raw data. A thrift-store experiment proves the point: stories can increase value by over 6,000%.Neuroscience: The Biology Behind the Narrative: Neuroscience shows that suspense, empathy, and humor trigger brain chemicals that boost attention, trust, and memory. That's why even experts remember stories far more than data dumps.Bridging Science and Story, Without Sacrificing Integrity: Many scientists fear storytelling undermines rigor, but David argues the opposite: story is the map, data the landmarks. Emotion doesn't weaken science, it makes it resonate and stick.Listen to the full episode to explore the straightforward storytelling structure David uses to bring scientific ideas to life.Don't let your breakthrough ideas get buried in jargon and dense slides. Your science deserves to be heard—and you already have what it takes to tell a story that sticks. Need help with an upcoming presentation?

From lab curiosity to commercial reality. Here's what happens when moss meets the brutal economics of bioprocessing.In Part 1, you've heard the science behind moss-based protein production. Now comes the real test: Can it survive the gauntlet of regulatory scrutiny, cost pressures, and manufacturing scale-up that crushes most biotech innovations?In Part 2 of this groundbreaking conversation, David Brühlmann and Andreas Schaaf, Managing Director and CSO of Eleva, dive into the nuts and bolts of what it actually takes to commercialize a revolutionary production platform. Andreas doesn't just theorize—he's lived through 15+ years of transforming Eleva from startup concept to clinical-stage reality, navigating every regulatory hurdle and economic challenge along the way.Three game-changing advantages that caught our attention:Process Robustness That Actually Works: While CHO cells throw tantrums over minor parameter shifts, moss maintains consistent product quality even when your bioprocess isn't behaving perfectly; a lifeline for manufacturing teams dealing with real-world variability.Economics That Make CFOs Smile: Forget expensive viral filtration steps and costly human pathogen testing. Moss's plant heritage eliminates these animal-system burdens, directly impacting your bottom line in ways that matter.Operational Simplicity: Variability in process ingredients and streamlined cell banking contribute to long-term cost and operational efficiencies that compound over time.Andreas shares hard-won insights about what it really takes to challenge entrenched bioprocessing orthodoxy, including the regulatory conversations, the economic realities, and his advice for scientists brave enough to pursue game-changing innovations.Ready to understand how disruptive biotechnology actually makes it from bench to bedside?Connect with Andreas Schaaf:LinkedIn: www.linkedin.com/in/andreas-schaaf-b3797716Website: www.elevabiologics.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show

What if the future of "impossible" protein therapeutics is hiding in your backyard?For decades, CHO cells have ruled the biotech kingdom as the undisputed champions of complex protein production. But here's the uncomfortable truth: countless breakthrough therapies are gathering dust on laboratory shelves—not because the science failed, but because traditional hosts can't produce them.Enter moss. Yes, moss. That humble green organism clinging to rocks and trees might just be the biotech industry's best-kept secret.In this eye-opening episode, David Brühlmann sits down with Andreas Schaaf, Managing Director and CSO of Eleva, who's spent over 20 years turning the "impossible" into reality. Andreas didn't just stumble upon moss; he co-developed Eleva's revolutionary moss-based platform from wild concept to commercial-scale game-changer, propelling the company into clinical trials.Here are three reasons why this episode is worth listening to:Moss as a Game Changer: More than a plant, moss is a higher eukaryote with mammalian-like protein production, including post-translational modifications and human-compatible glycosylation.Overcoming Bioprocessing Barriers: CHO cells are the industry gold standard, especially for monoclonal antibodies. But what about the therapeutic proteins that CHO can't handle? Many promising candidates end up shelved—not because the science isn't sound, but because existing production platforms hit their limits.Bioprocessing, Simplified: Moss grows in standard bioreactors using familiar workflows—just with a whole organism instead of suspended cells.Curious about how plant-based systems could solve your protein production challenges? Dive into this episode to discover how moss could revolutionize your approach to challenging proteins; and let us know about your own production hurdles.Connect with Andreas Schaaf:LinkedIn: www.linkedin.com/in/andreas-schaaf-b3797716Website: www.elevabiologics.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show

The world of cell therapy is changing rapidly, with revolutionary advancements in cryopreservation and bioprocessing protocols leading the way. In a recent episode of the Smart Biotech Scientist Podcast, host David Brühlmann sat down with Jeffrey Allen, Chairman and CEO of Evia Bio, to dive deep into the “how” of implementing cutting-edge techniques in the lab and the strategic mindset needed to move therapies from concept to clinic successfully.Jeffrey Allen is a passionate leader with a diverse background in shaping strategy, building high-performing teams, and driving exceptional results across public and private equity-backed organizations. With extensive C-level and international experience in the life sciences sector, Jeffrey has a proven track record of transforming performance and delivering profitable growth in various market environments.Here are three key takeaways for anyone passionate about advancing biotech:The four-step audit: bridging best practices and real-world results: Depending on client needs, the audit is performed either at the client's laboratory or at Evia Bio's own facility, ensuring real-world practices are scrutinized and optimized.Protocols matter and so does execution: Even the best-written protocols can falter if not followed meticulously. Regular process audits, sometimes conducted onsite by external partners, help identify “protocol creep” and ensure teams are consistently implementing best practices.Culture fuels innovation: Jeffrey's leadership advice resonated-aligning on strategy, fostering unified company culture, and surrounding yourself with talented people accelerates growth. Passion for the mission, combined with a strong, diverse team, can deliver both exceptional results and lasting employee engagement.Curious how these insights could save you months of frustration and millions in development costs? Tune in to the full episode, or get in touch to discuss how process optimization can empower your cell therapy journey!Connect with Jeffrey Allen:LinkedIn: www.linkedin.com/in/jeffreydallen2Website: www.eviabio.comEmail: jeffrey.allen@eviabio.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show

If you've ever worked in a cell therapy lab or handled biologics, you've probably experienced the pitfalls of cryopreservation. We've all mourned the loss of precious samples after a freeze-thaw cycle gone wrong or watched viability figures plummet, wondering where it all went awry.In this episode of The Smart Biotech Scientist Podcast, Jeffrey Allen, Chairman and CEO of Evia Bio, shares how nature-inspired solutions are changing the cell preservation game. With a background spanning finance, operations, and leadership across the biotech landscape, Jeffrey brings a unique perspective on bridging science and practical manufacturing needs.Inspired by the survival strategies of Minnesota's frozen forests, a new wave of biotech innovation is transforming the way we freeze, store, and ship life-saving cells for therapies - and it all starts with a better understanding of nature.Here are the top three takeaways from this podcast episode:Cryopreservation shouldn't be an afterthought: Building optimal cryopreservation strategies into your process development from day one can avoid costly setbacks and delays.Beyond cell viability - function matters: It's not just about how many cells survive the freeze/thaw cycle, but whether those cells remain fully functional. Evia Bio's new DMSO-free formulations are delivering >85% recovery on MSCs without compromising cell function.One size doesn't fit all: Every cell type has unique needs for freezing, thawing, and formulation. Leveraging tailored algorithms and customized protocols can drastically improve yield and reproducibility, potentially reducing the need for costly overfilling in manufacturing.If you've ever lost precious cell samples to a freeze-thaw mishap or questioned why you're stuck with outdated, toxic cryopreservation methods, this episode is for you!Connect with Jeffrey Allen:LinkedIn: www.linkedin.com/in/jeffreydallen2Website: www.eviabio.comEmail: jeffrey.allen@eviabio.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show

In this concluding episode of our deep dive into miniaturized perfusion systems, we tackle the most challenging aspect: implementing meaningful process analytical technology (PAT) at microscale while keeping costs realistic for high-throughput applications.Tom Valentin, group leader at CSEM for Automated Sample Handling, continues sharing CSEM's pioneering work in automated sample handling, revealing both the breakthrough opportunities and stubborn technical barriers that define the current state of small-scale perfusion development.Critical insights you'll gain from this episode:The PAT miniaturization challenge is about more than size: While optical density sensors work reasonably well for microbial cultures, mammalian cell applications demand more sophisticated solutions. Tom explains why viable cell density remains the "holy grail"—and how promising technologies from companies like IMEC and Inspec are pushing the boundaries, though cost-effective 96-well implementation remains elusiveSmart compromises can unlock practical solutions: Tom reveals why the industry may need to accept hybrid approaches—real-time pH and DO monitoring combined with once-daily viable cell density sampling. He also explains the unique challenges of sensor positioning in shaking deep-well plates where liquid dynamics create measurement complexitiesPartnership models that actually work for biotech innovation: Beyond the technical discussion, Tom outlines CSEM's proven collaboration approaches, including how Innoswiss funding can provide 50% cost reduction for development projects and why their 70% proposal success rate makes them an attractive R&D partner for both startups and established pharma companiesDiscover how bioprocessing is evolving - from high-throughput screening to digital twins and continuous manufacturing- in these expert-led episodes.Episode 155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes EverythingEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 73-74: Bead-Based Assays: The Power of High-Throughput Screening with Sebastian GiehringConnect with Tom Valentin:LinkedIn: www.linkedin.com/in/tom-valentin-5bb9091bWebsite: www.csem.ch/enEmail: thomas.valentin@csem.chNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show

In bioprocess development, the ability to rapidly screen conditions and predict scale-up performance can mean the difference between a successful therapy launch and costly delays. Today's Smart Biotech Scientist episode features Tom Valentin from CSEM, who's pioneering revolutionary approaches to miniaturized perfusion systems that could transform how we develop biologics.Tom is a group leader at CSEM for Automated Sample Handling within the Life Sciences and Industry 4.0 business unit. As a mechanical and biomedical engineer, he brings a unique cross-disciplinary perspective to solving bioprocessing's most challenging miniaturization problems.What makes this conversation essential listening:96-deep-well plates are revolutionizing perfusion development: Tom reveals how CSEM's innovative fluidic lids enable continuous medium exchange in 300-microliter volumes, potentially allowing up to 96 parallel perfusion experiments with automated liquid handlers and shaker incubatorsThree critical barriers still need solving: Despite the promise, Tom identifies the key technical challenges that must be overcome: ultra-low flow rate liquid handling (imagine exchanging 300 μL over 24 hours), effective cell retention in miniaturized systems, and cost-effective real-time biomonitoring that fits within well plate constraintsThe future of process development is automated and intelligent: From pressure-over-liquid systems to advanced sensor integration, Tom outlines how companies can achieve near-autonomous perfusion screening—but warns that current sensing limitations mean viable cell density monitoring remains the "holy grail" of small-scale perfusionThis isn't just about smaller equipment—it's about fundamentally changing how we approach process development. If you're working in cell culture optimization, process scale-up, or bioprocess automation, Tom's insights reveal both the tremendous opportunities and practical realities of implementing next-generation perfusion systems.For biotech professionals, staying ahead means embracing these high-throughput, data-rich models, allowing smarter, faster, and more predictive process development for the therapies of tomorrow.Discover how bioprocessing is evolving - from high-throughput screening to digital twins and continuous manufacturing- in these expert-led episodes.Episode 155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes EverythingEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 73-74: Bead-Based Assays: The Power of High-Throughput Screening with Sebastian GiehringConnect with Tom Valentin:LinkedIn: www.linkedin.com/in/tom-valentin-5bb9091bWebsite: www.csem.ch/enEmail: thomas.valentin@csem.chNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show

In this concluding episode of our series on revolutionary endotoxin detection, we continue our conversation with Anika Hoffmann about transitioning from theory to practice in the quest for more reliable, sustainable testing methods. Anika is a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland.Having established why traditional LAL testing falls short in Part 1, we now explore how Anika's innovative KDO-based chemical analytical approach compares in real-world applications:Greater accuracy you can trust: The new method delivers impressive 5-10% coefficient variation (compared to LAL's 25%), works across broader pH and formulation conditions, but is still working toward the sensitivity targets needed for all pharmaceutical applicationsClear path to regulatory acceptance: Anika outlines how companies can validate alternative methods against established standards like LAL, recombinant Factor C, or monocyte activation tests to gain approval from authoritiesSustainable testing strategy: Health authorities and customers are increasingly demanding sustainable alternatives as horseshoe crab populations decline while testing demand rises—adopt ethical, animal-free methods now before they become an industry requirementMost excitingly, Anika reveals her entrepreneurial journey from accidental discovery to startup founder. Her passion for solving this critical industry challenge exemplifies how scientists can transform technical innovations into practical solutions that benefit both industry and the environment.Whether you're a bioprocess scientist struggling with endotoxin testing, a quality assurance professional seeking more reliable methods, or someone interested in sustainable alternatives to animal-based testing, this episode provides a clear path toward a future where patient safety doesn't rely on horseshoe crab blood.Listen now to discover how you can implement smarter endotoxin testing at your organization – and reach out to Anika via the links in our show notes if you want to be among the first to access this groundbreaking technology.Connect with Anika Hoffmann:LinkedIn: www.linkedin.com/in/anika-hoffmann-652ab0196/Email: anika.hoffmann@hevs.chNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/Support the show

Send us a textIn biopharmaceutical manufacturing, endotoxins represent a silent but deadly threat – bacterial fragments capable of triggering severe immune responses at picogram levels, potentially leading to septic shock, organ failure, or even death in patients.In this eye-opening first episode, we speak with Anika Hoffmann, a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland, who's challenging the decades-old status quo of endotoxin testing. For nearly 50 years, the industry has relied on horseshoe crab blood (LAL assay) despite its significant limitations and sustainability concerns.Anika reveals the troubling truth about traditional testing methods:The LAL reliability problem: With acceptable recovery rates ranging from 50-200% and high variability, can we truly trust our current methods?The "low endotoxin recovery" phenomenon: How common pharmaceutical ingredients can mask dangerous endotoxins, creating false negativesThe horseshoe crab sustainability crisis: Rising testing demand threatens declining horseshoe crab populationsMost importantly, Anika introduces her groundbreaking alternative: a chemical analytical method targeting KDO, a unique sugar molecule present in all endotoxins. This approach eliminates reliance on enzymes or animal products while providing more consistent results across different pharmaceutical formulations.With regulatory limits as strict as 0.25 EU/mL for water for injection, reliable detection isn't just a quality issue – it's a patient safety imperative. If you're developing biologics, managing bioprocess quality, or navigating regulatory compliance, this episode reveals why rethinking endotoxin testing could be your most important decision.Listen to Part 1 to discover why smarter endotoxin testing is possible without relying on horseshoe crab blood, and stay tuned for Part 2 where we'll explore the practical implementation of this revolutionary approach.Connect with Anika Hoffmann:LinkedIn: www.linkedin.com/in/anika-hoffmann-652ab0196/Email: anika.hoffmann@hevs.chNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/

Send us a textThe world of biologics manufacturing is undergoing a major transformation. Once dominated by traditional batch processes, the industry is now experiencing a marked shift toward continuous bioprocessing.But as companies contemplate this transition, two questions dominate strategic discussions: Will regulators accept continuous manufacturing? And, perhaps more pressingly, Does the business case justify making the switch?In this podcast episode of the Smart Biotech Scientist Podcast, David Brühlmann dives into these pivotal topics - drawing insights from real-world case studies, regulatory updates, and economic analyses.Top three takeaways:Regulators Are On Board: The FDA, EMA, and global agencies now actively support continuous processing when robust controls and monitoring are in place.Real Economic Wins: Cost of goods reductions of up to 35% are possible at certain production scales, with much smaller facilities and lower risk of batch failure.Hybrid & Phased Approaches Work: Companies are finding success by first investing in enabling technologies and gradually transitioning, rather than making sudden changes.Continuous bioprocessing is no longer an experimental promise - it's an evolving standard. With regulatory bodies championing the shift, real-world implementations proving technical and economic viability, and strong financial incentives for the right manufacturers, the transition becomes not a question of “if,” but “when.”Curious how continuous manufacturing can fit into your strategy? Listen to this episode and share your thoughts or questions!Next step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textIn this episode of the Smart Biotech Scientist Podcast, host David Brühlmann dives into continuous bioprocessing - a major shift in biologics manufacturing that's turning traditional batch processes into streamlined, real-time operations.Imagine running your biologics process non-stop for 30 days, with smart monitoring and smaller, more efficient systems replacing massive reactors. It's not just possible - it's already happening across the industry, from Amgen's 80% smaller facility to Sanofi's modular "Factory of the Future."David explores how companies - big and small - are increasing productivity, cutting costs, and reducing waste through continuous strategies. You'll also hear about enabling technologies, phased implementation approaches, and the challenges teams are navigating as they make the shift.Top 3 Takeaways:Efficiency & Cost Savings Are Real: Amgen's results speak volumes: 80% smaller footprint, faster deployment, and cost reductions of over 60% per gram of protein.It's Not Just for Big Pharma: Small and mid-sized biotechs are embracing continuous processes to stay competitive - gaining speed, flexibility, and lowering production costs without massive infrastructure.You Don't Have to Go All In: Challenges like cost, complexity, and workforce readiness exist - but many companies are succeeding with hybrid models, applying continuous techniques step-by-step.What's your take on continuous manufacturing? Tune in, share your thoughts, and join the conversation about the future of biotech production.Next step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textIn this episode, Tiago Matos, Associate Principal Scientist/Associate Director in Bioprocess Drug Substance and Commercialization at Merck & Co., shares a critical insight: continuous manufacturing in biologics currently demands 2–3x more time and FTEs than traditional fed-batch approaches. This highlights both the complexity of the shift - and the urgency for smarter digital tools and cross-functional collaboration.With over a decade of experience and a strong track record in biologics and smart manufacturing, Tiago brings a balanced view of the promise and practical challenges of digital transformation in bioprocessing.Top 3 Takeaways:Continuous Manufacturing is Coming - But Slowly: The infrastructure and tools aren't fully ready. Progress depends on better-integrated solutions and stronger collaboration across industry, equipment providers, and regulators.Collaboration is Key: No one drives transformation alone. Digital, automation, modeling, and process experts must work together - like building a functional protein from diverse amino acids.Digital Twins and AI Will Bridge the Gap: AI, soft sensors, and digital twins will help streamline control strategies. The goal isn't perfect models, but reliable, adaptive systems that improve in real time.Tiago's vision is both realistic and inspiring: the future of biologics manufacturing lies in openness, teamwork, and continuous learning.What challenges or questions do you face in the shift to digital bioprocessing?Here is what other guests had to say on this topic:Episodes 5-6: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov;Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli;Episodes 121-122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger.Connect with Tiago Matos:LinkedIn: www.linkedin.com/in/tiagobmatosMerck & Co.: www.merck.comNext step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textAs the biotechnology sector races toward digital transformation, the buzz around Industry 4.0 - with its promise of interconnected systems, automation, and data-driven operations - has never been louder. But is the industry truly ready?In this episode, we speak with Tiago Matos, Associate Principal Scientist/Associate Director in Bioprocess Drug Substance and Commercialization at Merck & Co., who brings a grounded, insider view. Despite the hype, he says most of biopharma is still operating at an “Industry 3.2” level.With over a decade of experience in biologics and vaccines, Tiago leads teams pushing digital innovation forward - through tools like digital twins, advanced control strategies, and smart manufacturing platforms.Key takeaways from this episode:Biotech is slowly transitioning toward true Industry 4.0, through collaboration and strategic leadership.Digital twins aren't for everything. Focused use in platform processes yields the best return - broad implementation can be costly and complex.Regulators are ready. Far from being a barrier, they're encouraging innovation and open to new ideas.Curious to learn more? Check out the full blog post for deeper insights, and let us know your thoughts in the comments - how close do you think biomanufacturing is to a true digital revolution?Here is what other guests had to say on this topic:Episodes 5-6: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov;Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli;Episodes 121-122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger.Connect with Tiago Matos:LinkedIn: www.linkedin.com/in/tiagobmatosMerck & Co.: www.merck.comNext step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textIs an Indian CDMO the right move for your biologics CMC development?Pulling back the curtain on what might be your next strategic manufacturing advantage, this episode reveals the hidden capabilities emerging from India that leading biotech companies are racing to access. As supply chain vulnerabilities continue to expose risks in traditional manufacturing models, could the solution lie halfway around the world?Joining us to reveal the inside story is Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck and Lonza. With over 20 years in biotech, Abdelaziz brings unique insights on when and why you might want to look beyond traditional Western manufacturing partners. Our host, David Brühlmann, leverages his 15+ years of biotech industry experience to extract the practical insights you need to make informed decisions about your manufacturing strategy.In this second segment, we'll dive deeper into the Indian CDMO and biomanufacturing landscape. Then we'll explore Lupin's specialized capabilities and finally extract Abdelaziz's most valuable leadership insight from his role as a CEO.Key insights from this episode:The One-Stop Solution Advantage: Discover how Lupin is building rare end-to-end manufacturing capabilities for complex modalities like Antibody-Drug Conjugates (ADCs) - potentially eliminating the headache of managing multiple manufacturing partners across continents.Beyond Labor Cost Advantages: "Digitalization plays a key role, especially if you are operating in a cost-competitive space," explains Abdelaziz. Learn how Indian CDMOs are strategically automating key processes to drive both efficiency and quality, challenging Western perceptions.Leadership Across Cultures: "Listen, listen, listen," emphasizes Abdelaziz when discussing cross-cultural leadership. Understand the subtle communication dynamics that can make or break a global manufacturing partnership, especially when navigating hierarchy-sensitive cultures.Whether you're actively evaluating Indian manufacturing options or simply preparing for the shifting global biotech landscape, these next several minutes deliver insights you can't afford to miss.Listen to the full episode to extract the specific capability indicators that will help you determine if and when an Indian CDMO partnership makes strategic sense for your unique biologics pipeline.Want to find out more about the CDMO selection? Here's what one of our distinguished guests had to say about it:Episodes 103-104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma MostafaConnect with Abdelaziz Toumi:LinkedIn: www.linkedin.com/in/abdelaziztoumiLupin Manufacturing Solutions: www.lupin.comNext step:Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textIs an Indian CDMO the right move for your biologics pipeline?As Western biotech companies seek new strategic advantages, one question keeps surfacing: Is India truly becoming the next biotech manufacturing powerhouse? And what hidden capabilities are emerging that leading companies are racing to access?In this episode of the Smart Biotech Scientist Podcast, Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck, and Lonza, joins host David Brühlmann to reveal the inside story on when and why you might want to look beyond traditional Western manufacturing partners.Here are three key insights from their conversation:The Post-Pandemic Manufacturing Revelation: "During the pandemic, we realized how vulnerable our supply chain truly is," explains Abdelaziz. Discover why diversifying manufacturing partnerships isn't just smart—it's becoming essential for resilience in an unpredictable world.Beyond the Cost Advantage: While Indian CDMOs can deliver up to 80% cost savings compared to Western counterparts, Abdelaziz reveals the unexpected advantages that make the most strategic partnerships about far more than budget considerations.The Trust Factor: "This is a business of trust," emphasizes Abdelaziz. Learn the critical questions that separate world-class Indian CDMOs from the rest, and the cultural nuances that can make or break your manufacturing partnership.Ready to discover if Indian CDMOs could be the missing piece in your biologics development strategy? Tune in for expert insights on IP protection, talent access, and how to navigate the cultural dynamics that determine success in this emerging manufacturing powerhouse.Listen to the full episode to unlock the strategic advantage that could transform your pipeline's journey from lab to market.Want to find out more about the CDMO selection? Here's what one of our distinguished guests had to say about it:Episodes 103-104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma MostafaConnect with Abdelaziz Toumi:LinkedIn: www.linkedin.com/in/abdelaziztoumiLupin Manufacturing Solutions: www.lupin.comNext step:Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textAs biotech labs rush to adopt AI tools for cell culture media development, a critical question emerges: Are we creating a generation of scientists who know which buttons to push but not why they're pushing them? The automation trap that once transformed laboratory workflows now threatens to fundamentally alter how we understand the complex dynamics of culture media composition and performance.In this second part of our conversation with Tom Fletcher, R&D Director at Fujifilm Irvine Scientific, host David Brühlmann explores the practical challenges of implementing AI in cell culture media development while preserving the scientific thinking that drives true innovation.Key Insights from Their Conversation:The Knowledge Generation Imperative: "Don't just think of your job as picking winners out of random experiments," Tom warns. He emphasizes that scientists must prioritize understanding why a specific media formulation works, not just that it works—a distinction that becomes critical as AI makes high-throughput media screening increasingly accessible.Bridging Disciplinary Divides: As teams become more diverse—incorporating data scientists, automation specialists, and traditional bioprocess experts—success depends on creating a collaborative culture where specialists learn to leverage each other's strengths without expecting everyone to have the same foundation in cell culture fundamentals.The Future Bioprocessing Landscape: Tom predicts that while platform media will dominate for speed to clinic, human roles will evolve toward managing automated, digitalized processes with fewer but more technically specialized staff. The media developers who thrive will be those who can maintain scientific rigor while harnessing the power of automation.For biotech leaders navigating this technological transition, Tom's advice is clear: "Embrace AI because I think we all believe it's valuable, but don't allow lazy science to creep in... if you don't resist it, people are going to get lazy and just say 'I've got this supercomputer and I know which buttons to push.' That's not good enough."If you enjoyed this conversation, be sure to explore how it all began:Episodes 1-2: Unlock the Power of Rational Media Design in Bioprocessing with Tom FletcherConnect with Tom Fletcher:LinkedIn: www.linkedin.com/in/tomfletcher2FUJIFILM Irvine Scientific: www.irvinesci.comThe views and opinions expressed by Tom Fletcher are his own and do not necessarily reflect those of Fujifilm Irvine Scientific or its affiliates.Next step:Transform your cell culture media development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotechNote: These are Tom's personal opinions and not his company's.

Send us a textFrom closely-guarded secrets to complex chemical interactions, cell culture media development has transformed from an afterthought to a critical competitive advantage in modern bioprocessing. But as AI and automation revolutionize the field, are we at risk of gaining speed while losing understanding?In this eye-opening episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Tom Fletcher, R&D Director at Fujifilm Irvine Scientific, who brings over 30 years of experience and a unique perspective on balancing technological innovation with scientific rigor.Key Insights from Their Conversation:The Evolution of Media Formulations: Tom traces the remarkable journey from basic serum supplements to today's chemically defined media with 60-70+ precisely balanced components, transforming what was once "just that stuff you bought" into one of bioprocessing's most closely guarded competitive advantages.The Collaborative Intelligence Framework: The most powerful approach combines artificial intelligence with human intelligence (AI + HI = CI), where technology enhances rather than replaces scientific thinking to generate not just data, but genuine process understanding.Avoiding the Automation Trap: "Don't get lazy with technology," Tom warns, emphasizing that the goal remains generating knowledge about why processes work, not just identifying which conditions perform best—a crucial mindset as companies increasingly adopt powerful AI tools.If you enjoyed this conversation, be sure to explore how it all began:Episodes 1-2: Unlock the Power of Rational Media Design in Bioprocessing with Tom FletcherConnect with Tom Fletcher:LinkedIn: www.linkedin.com/in/tomfletcher2FUJIFILM Irvine Scientific: www.irvinesci.comThe views and opinions expressed by Tom Fletcher are his own and do not necessarily reflect those of Fujifilm Irvine Scientific or its affiliates.Next step:Transform your cell culture media development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textIn the wake of the COVID-19 pandemic, the fragility of global blood supply systems became undeniably clear. Recognizing the urgent need for a more reliable and universal solution, Ari Gargir and his team at RedC Biotech are leading an ambitious effort to transform blood supply as we know it. Their mission? To develop lab-grown red blood cells that not only address chronic shortages but also overcome blood type compatibility - an innovation with the potential to reshape modern medicine.As the CEO and founder of RedC Biotech, Ari brings a powerful personal story to this mission. After a near-fatal paragliding accident, a life-saving transfusion ignited his determination to create a scalable, donor-free blood alternative. Now, through pioneering bioprocessing techniques, he and his team are working to produce universal red blood cells that could serve nearly anyone, anywhere.In this episode, we explore:Bioprocessing Breakthroughs: How RedC Biotech transforms stem cells into red blood cells - scaling from lab flasks to industrial bioreactors - and the key challenges in making this process scalable and cost-effective.Quality and Cost Challenges: The rigorous standards for safety, efficacy, and affordability, and how RedC Bioteh is tackling them to produce viable blood units at scale.Why Now? - Ari shares why this moment is uniquely suited for breakthroughs in blood biotech, thanks to recent advancements in Induced pluripotent stem cell (iPSC) technology and hard lessons learned from COVID-19.Listen to the full episode for Ari's insights and advice for biotech entrepreneurs navigating bold, high-impact innovations.Connect with Ari Gargir:LinkedIn: www.linkedin.com/in/ari-gargir-7107035RedC Biotech: www.redcbiotech.comNext step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textBlood is critical to global healthcare - vital for surgeries, trauma care, cancer treatment, and maternal health. Yet despite 120 million donations each year, a 100 million unit shortfall means nearly half the world's needs go unmet.One person who understands this crisis firsthand is Ari Gargir, CEO & Founder of RedC Biotech. After surviving a paragliding accident thanks to a life-saving transfusion, he set out to tackle the global blood shortage. His team is now developing universal, lab-grown red blood cells, eliminating the need for donors.The added transitional phrase creates a smoother flow between the global problem and the personal story that follows.Don't miss these key insights from the full conversation:The Global Crisis: Ari painted a vivid picture of the current state of blood supply. The problem is multifaceted - logistical issues, biological challenges, and socio-economic disparities in blood distribution exacerbate this shortage. Developed nations possess more blood resources, but low-income countries, where donation rates are staggeringly low, continually grapple with severe shortages.Innovative Solutions: We learned about the groundbreaking technology Ari is developing at RedC Biotech. Using stem cells, they aim to create unlimited, universal, and donor-free red blood cells. This could be a game-changer, not only for transfusions but also for advanced therapeutic uses.Impact on Healthcare: Ari is a strong advocate for O-negative blood, which can be used for up to 98% of people. But he's especially focused on vulnerable patients - those with sickle cell disease, thalassemia, and complex immune conditions - who may need frequent transfusions.Our conversation with Ari underscores the importance of innovation in biotechnology to address critical global healthcare issues. By creating a reliable, scalable supply of red blood cells, RedC Biotech holds the promise of saving countless lives and improving the quality of life for those dependent on regular blood transfusions.Tune in to hear how Ari and RedC Biotech are shaping the future of transfusion medicine.Connect with Ari Gargir:LinkedIn: www.linkedin.com/in/ari-gargir-7107035RedC Biotech: www.redcbiotech.comNext step:Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Send us a textStuck with outdated analytics while trying to develop cutting-edge therapies? Part 2 of our conversation with Bruno Oesch, CEO and founder of Elionova, reveals how biotech scientists can finally break free from incremental improvements and embrace the revolutionary immunoassay technology that's transforming bioprocessing workflows worldwide.For years, ELISA (Enzyme-Linked Immunosorbent Assay) has been vital in biotechnology, but its time-consuming protocols and complex washing steps slow bioprocess development, creating bottlenecks in advancing therapies.Bruno's team is transforming the field of immunoassays with an innovative technology that delivers quantitative results in just 10 minutes—without the need for washing steps.Here are three key takeaways from the conversation:Market Introduction Strategy: Bruno emphasizes the importance of placing the product directly in the hands of potential customers. By offering free trials, users can experience its value firsthand, creating a strong incentive for continued use.Building an Open Community: Elionova fosters a collaborative environment where users can develop and share assays. Their vision follows an app store model, encouraging innovation and knowledge exchange within the biotech space.Vision for the Future: Beginning with research labs, Elionova aims to expand into diagnostics, particularly in veterinary medicine, due to lower regulatory hurdles. Their long-term goal is to make a significant impact in point-of-care diagnostics, offering rapid results crucial for emergency medical scenarios.If you're a biotech professional looking to streamline bioprocess workflows and drive innovation, Bruno Oesch's transformative approach may provide the inspiration you need. Stay ahead of industry advancements by tuning into this episode to learn more about connecting with Oesch and exploring Elionova's novel technology.Connect with Bruno Oesch:LinkedIn: www.linkedin.com/in/bruno-oeschElionova: www.elionova.comNext step:Ready to revolutionize your bioprocess workflows? Book a free consultation at https://bruehlmann-consulting.com/call to discover how real-time analytics can transform your development timeline.

Send us a textTired of waiting overnight for ELISA results? Serial entrepreneur Bruno Oesch reveals how his groundbreaking 10-minute immunoassay technology is eliminating the biggest bottleneck in bioprocessing workflows.From contributing to Nobel Prize-winning prion research to founding Prionics (the first commercial BSE test) and now revolutionizing immunoassays with Elionova, Bruno transforms high-end science into practical solutions that work for everyday labs.Here are three takeaways from this podcast episode:ELISA - The Lab Workhorse That Still Matters: Since the 1970s, ELISA assays have been a cornerstone of bioprocessing and diagnostics. As Bruno Oesch puts it, they remain the "workhorses of biochemical labs." Despite requiring over four hours of binding and washing steps, ELISA remains widely used for its affordability and reliability. However, its slow, linear workflow calls for innovation.ElioDX - The Next-Gen Immunoassay: While Elionova didn't invent evanescence, they've made it accessible and practical. Instead of lengthy washes, a laser-generated evanescent field enables real-time detection, delivering results in just 10 minutes by measuring signal changes dynamically.The Future of Real-Time Bioprocessing: This breakthrough eliminates bottlenecks in biotech workflows. By integrating real-time analysis, ElioDX enhances efficiency, decision-making, and continuous bioprocessing, ensuring precise insights exactly when they're needed.As David and Bruno highlight, the future of immunoassays isn't just about innovation - it's about making these advancements practical and transformative across the industry.By bridging science and accessibility, leaders like Bruno Oesch play a crucial role in demystifying bioprocessing, sparking impactful discussions, and driving real change in the scientific community.Listen to the full discussion to explore how this real-time approach can streamline bioprocessing and transform your workflows.Connect with Bruno Oesch:LinkedIn: www.linkedin.com/in/bruno-oeschElionova: www.elionova.comNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

Send us a textImagine a future where every patient can access life-saving therapies and sustainable, high-quality food is within everyone's reach. In this episode of the Smart Biotech Scientist, David Brühlmann explores how innovative biotech developments are making this vision a reality.Here's a sneak peek of the breakthroughs covered:AI-Powered Picoliter Scale Testing: Discover how companies like Triple Bar Bio are pushing the boundaries of what's possible with their innovative microfluidic technology that screens individual cells. Their approach enables rapid identification the best cell producers, paving the way for more efficient and precise bio-manufacturing.Hybrid Models for Process Prediction: Learn about DataHow's cutting-edge hybrid models that predicts process outcomes and improves product quality. Their models have demonstrated the potential to reduce the number of experiments by up to 80%.Unconventional Bioreactor Approaches: Explore an intriguing proposition – could tomorrow's bioreactors be living organisms like goats? BioSourcing is exploring the potential of transgenic goats to produce biopharmaceuticals more affordably, a concept that could dramatically lower production costs and enhance accessibility.The future of biotech is not just about technological advancement; it's about embracing the impact these innovations can have globally. As David urges, the challenge is no longer about if these changes will happen, but how quickly we can achieve them.Stay curious, keep innovating, and be part of this exciting transformation in biotech. Your contributions and feedback could shape the next generation of breakthroughs.Listen, learn, and let us know what you think about these advancements. We can't wait to hear from you!If you enjoyed this, here are some episodes worth listening:Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllEpisode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use DailyEpisode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesEpisodes 41-42: Revealing the Disciplined Pursuit of Less in BioprocessingNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/callDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textIn the rapidly evolving world of biotechnology, innovation is not just happening at the molecular level. Industry leaders are making groundbreaking advancements in bioprocessing - a crucial component in making life-saving therapies more accessible and affordable.The journey to affordable therapies starts with the production process itself. In this podcast episode, David Brühlmann sheds light on innovations in bioprocess design that are setting new standards in efficiency and efficacy. At the heart of this transformation is the shift from traditional process formats like fed-batch to continuous process formats, quality by design approaches, and the implementation of breakthrough technologies.Here's a quick rundown of the key takeaways:Revolutionary Process Designs: Industry leaders are enhancing bioprocess designs—from antibody production enhancements to integrating perfusion mode. One case study highlighted a dramatic increase in viable cell density and protein titers through intensified processes.Quality Control Innovations: Companies like Cyto-Facto are pioneering quality by design in the challenging cell and gene therapy space. By leveraging sophisticated PAT systems, they can monitor critical process parameters in real-time, ensuring consistent quality even in complex bioprocesses.Metabolite Shifts and Efficacy: A surprising discovery revealed the power of metabolite shifts induced by cell culture media design, inspired by an intriguing study on cyclists, to enhance antibody efficacy and stability. This opens new possibilities for engineering the quality of biopharmaceuticals through simple modifications in the culturing process.The innovations discussed in the Smart Biotech Scientist illustrate a pivotal transformation in bioprocessing. By rethinking process designs and committing to quality control, the biotech industry is paving the way for groundbreaking therapies that are not just dreams but realities - realities that are tangibly more accessible to patients worldwide.As we anticipate more developments in this field, the promise of biotech becomes increasingly certain: a future where life-saving treatments are affordable and available to all who need them.Catch the full episode to explore how these innovations are not just improving efficiency but making life-saving therapies more accessible globally.If you enjoyed this, here are some episodes worth listening:Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllEpisode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use DailyEpisode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesEpisodes 41-42: Revealing the Disciplined Pursuit of Less in BioprocessingNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/callDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textWhat if we could revolutionize biotechnology by slashing antibody production costs by 70%? In a world where traditional mammalian cell cultures struggle with scalability and cost-effectiveness, an unexpected hero emerges from the depths of our oceans - microalgae.The use of microalgae in biotechnology is not just a novelty but a necessity, given the current demands for more efficient and cost-effective production methods. Muriel Bardor, co-founder, CEO and CSO of Alga Biologics, highlights a particularly startling statistic: microalgae can reduce the cost of antibody production by an impressive 70%. This innovation could revolutionize the biotechnology industry by making life-saving therapies more accessible.Here are 3 key takeaways from this podcast episode:Quality and Safety Assurance: By collaborating with virology experts and using advanced techniques like mass spectrometry, they ensure that their processes are virus-free and free from host-cell protein contamination. The company is paving the way for future developments despite the challenges of not having standard ELISA kits commercially available.Regulation and Industry Perception: Launching such transformative technology inevitably entwines with regulatory landscapes. Muriel and her company have begun discussions with the French regulatory agency, drawing optimism from the fact that similar plant-based products, such as glucocerebrosidase, have already paved the way in the market. This indicates a growing acceptance within regulatory bodies of alternative bioprocessing platforms, inspiring hope for microalgae's future in antibody production.Future Vision: Muriel hopes to break conservative barriers within pharmaceutical companies and promote the adoption of microalgae production. This offers not only cost-effective solutions but also holds potential for new treatment options, like for neuroblastoma.Check out the episode to hear Muriel's advice for aspiring scientists and the general public alike regarding the future of research and the well-being of our planet.Connect with Muriel Bardor:LinkedIn: www.linkedin.com/in/muriel-bardor-47953024Email: muriel.bardor@univ-rouen.frAlga Biologics: www.algabiologics.comNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

Send us a textThe world of biologics manufacturing is about to be transformed by a breakthrough that slashes antibody production costs by 70%. This revolutionary approach leverages the untapped potential of microalgae to deliver a sustainable, cost-effective solution that could make life-saving therapeutics more accessible than ever before. Enter microalgae, the star of this groundbreaking development.In this episode of the Smart Biotech Scientist, Muriel Bardor, the co-founder, CEO and CSO of Alga Biologics, shared insights into how her team's pioneering work with microalgae could redefine the landscape of immunotherapy.Here are some takeaways from her conversation with David Brühlmann:Green Revolution in Bioprocessing: Discover how microalgae can slash production costs by 70% and offer a sustainable alternative to traditional antibody manufacturing. Muriel explains how these photosynthetic organisms capture 7 tons of CO2 per kilogram of product - transforming antibody manufacturing both economically and environmentally.Rethinking Antibody Production: Learn why the conventional use of mammalian cells in antibody production is being challenged and how microalgae overcome the limitations of traditional methods, bringing life-saving drugs within reach for more people globally.Sustainable Impact: With a process that mirrors nature, Muriel's approach sets a new standard for eco-friendly biotech production. Find out how microalgae are changing not just the industry, but our world.We invite you to listen to this insightful conversation and explore how you can apply these groundbreaking ideas to your own work. Has Muriel's innovative approach inspired you? Share your thoughts or questions with us - we'd love to hear from you!If you are interested in antibody production, here is another episode worth listening:Episodes 47-48: Mastering Process Economics: Driving Down Costs in Antibody Production with Brian KelleyConnect with Muriel Bardor:LinkedIn: www.linkedin.com/in/muriel-bardor-47953024Email: muriel.bardor@univ-rouen.frAlga Biologics: www.algabiologics.comNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech

Send us a textIn this episode, we explore the important steps in preparing for regulatory meetings, address the dangers of cross-contamination in biotechnology facilities, and debunk common misconceptions that could derail your CMC development strategy.As the founder and president of ADRES - Advanced Regulatory Services Ltd., Rivka Zaibel brings over 36 years of industry experience and practical strategies to help navigate the intricacies of CMC development and regulatory compliance.Here are three key takeaways:Risk Assessment is Paramount: Start risk assessments in parallel with facility design to prevent cross contamination. Remember, areas for both mammalian and microbial cells should be segregated to ensure safety.Early Engagement with Regulatory Agencies: Don't wait until everything is finalized before consulting with regulatory bodies. Engaging them early can ensure your plans align with their requirements and might even spark valuable advice you hadn't considered.Understand and Plan Your Product Journey: Have a clear vision of your final product from the start, and plan backwards. This approach ensures all supporting processes are adequately addressed, saving time and preventing costly mistakes down the line.Ultimately, successful biologics development hinges on thorough understanding and strategic planning. This includes comprehensive risk assessments, early regulatory engagement, and a commitment to continuous training and facility validation.Rivka's insights offer a roadmap for navigating this complex landscape, aiming to deliver groundbreaking therapies with precision and compliance. By following these expert strategies, biotech professionals can streamline their processes, avoid common pitfalls, and ensure the successful introduction of their products to the market.Connect with Rivka Zaibel:LinkedIn: www.linkedin.com/in/rivka-zaibel/ADRES - Advanced Regulatory Services Ltd.: www.adres.bioEmail: tanya@adres.bioNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textIn biotherapeutic drug development, the journey from discovery to clinic involves navigating a labyrinth of regulatory requirements and strategic considerations, particularly in Chemistry, Manufacturing, and Control (CMC).In this episode of the Smart Biotech Scientist, host David Brühlmann engaged with Rivka Zaibel, President and Founder of ADRES - Advanced Regulatory Services Ltd. - to demystify the regulatory intricacies of biologics development and provide actionable insights for biotech leaders.With over three decades of experience in the biopharmaceutical industry, Rivka Zaibel highlights that understanding the regulatory landscape is crucial for the success of biologics development.Here are three key takeaways from this episode:Prioritize CMC Development Early: CMC (Chemistry, Manufacturing, and Controls) development is crucial in biologics. Rivka emphasizes starting early and engaging with regulatory agencies to avoid costly delays and streamline the bioprocessing journey.Understand Regulatory Differences: Different agencies (FDA vs. EMA) may have varied interpretations of guidelines. Familiarize yourself with ICH guidelines and the specific requirements of each agency to align your strategy effectively.Leverage Existing Resources: Before developing your own product pathway, explore existing European Public Assessment Reports (EPARs) and summary bases of approval for comparable products. This research can provide valuable insights into regulatory expectations and streamline your approach.For startups navigating the complexities of CMC development, Rivka highlights three critical quality and regulatory considerations essential for reaching Phase 1 trials. By embracing these key insights, biotech professionals can streamline the path to delivering innovative therapies to patients safely and efficiently.In conclusion, as you continue your journey within the biopharmaceutical industry, let the Smart Biotech Scientist serve as your guide, demystifying the complexities and empowering you with the tools needed to thrive. Stay informed, stay proactive!Connect with Rivka Zaibel:LinkedIn: www.linkedin.com/in/rivka-zaibel/ADRES - Advanced Regulatory Services Ltd.: www.adres.bioEmail: tanya@adres.bioNext step:Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech

Send us a textIn the fast-evolving world of biotechnology, the pursuit of efficiency and faster development has never been more critical. The computational tools and models currently being integrated into bioprocessing present a groundbreaking approach that promises radical shifts in drug development timelines and capabilities.In the second part of our conversation, Yossi Quint, founder and CEO of Ark, shows us that the horizon of bioprocessing is lined with possibilities that could revolutionize biotherapeutics accessibility, cost, and speed in pharmaceutical innovations.Here are three key takeaways you don't want to miss:De-risking with Simulation: Yossi shared how simulation models can drastically reduce risks by running many scenarios before actual implementation. This approach optimizes processes, lowers costs, and speeds up the development cycle.Transfer Learning in Bioprocessing: Discover the potential of leveraging data across different types of molecules! Although challenging, the ultimate goal is to apply data learnings from one process to others, maximizing efficiency and success rates.Patient Impact & Cost Reduction: At the heart of these innovations is the goal of quicker, more affordable drug production. By slicing down on both time and costs, computational tools not only help drugs reach the market faster but also make them more accessible to patients globally.With innovation at its core, the modern trajectory of bioprocessing is not simply about reaching scientific milestones but about profoundly transforming patient care and accessibility. This synergistic blend of technology and purpose crafts a future in which the biotechnology sector not only grows but also enriches countless lives around the globe.If you are interested in this topic, here are a few standout conversations on AI's impact on bioprocessing with some incredible experts:Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza FarahaniEpisodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma AlispahicConnect with Yossi Quint:LinkedIn: https://www.linkedin.com/in/yossi-quintArk: https://www.ark-biotech.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textThe integration of AI into drug discovery has already led to groundbreaking advancements, uncovering patterns in vast datasets that were previously invisible to human researchers. Now, AI is set to revolutionize bioprocessing as well.In this episode of the Smart Biotech Scientist Podcast, Yossi Quint, founder and CEO of Ark, and David Brühlmann explore how AI and computational tools are reshaping bioprocess development. Yossi envisions a future where 90% of bioreactor experiments could be replaced by in silico simulations, dramatically accelerating time to market and increasing throughput.Key takeaways from the conversation with Yossi Quint:AI's Role in Drug Discovery & Bioprocessing: AI is already transforming drug discovery by identifying intricate patterns across millions of data points. Now, bioprocessing is undergoing a similar revolution, as computational tools simplify and streamline complex workflows.The Power of Hybrid Models: Yossi highlights the synergy between mechanistic models and AI-driven approaches, emphasizing how AI can fill gaps where traditional models struggle—especially in understanding complex cellular behaviors.Empowering Bioprocess Teams with AI: As AI accelerates drug discovery, bioprocessing must evolve to keep pace. Yossi discusses the importance of digital transformation in ensuring bioprocess teams can meet increasing demands and drive innovation forward.With AI-driven models, hybrid simulations, and increased digitization, the bioprocessing industry stands at the cusp of a new era. The convergence of data, science, and technology promises not only greater efficiency and accuracy but also a faster path to life-saving treatments for patients in need.If you want to learn more, here are a few standout conversations on AI's impact on bioprocessing with some incredible experts:Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza FarahaniEpisodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars BrandénEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma AlispahicConnect with Yossi Quint:LinkedIn: https://www.linkedin.com/in/yossi-quintArk: https://www.ark-biotech.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textSickle cell disease, a genetic disorder affecting thousands, presents a daily struggle akin to having shards of glass tearing through one's veins. Despite breakthrough gene therapies approved by the FDA, the prohibitive cost of $2.2 million per treatment limits their accessibility.In the latest episode of the Smart Biotech Scientist Podcast, host David Brühlmann discusses five critical challenges the bioprocessing industry must overcome to make these life-saving therapies accessible to a broader population.Moving Away from Platform TechnologiesTraditional bioprocessing has relied heavily on platform technologies, particularly in the production of antibodies. This conventional method involves cultivating cells in bioreactors, predominantly CHO cells, followed by a series of purification steps. This well-established process is now being disrupted by new modalities that cannot adhere to this template. As the industry progresses, creating flexible and scalable systems compatible with novel therapies becomes essential.Increased Personalization and Smaller Batch SizesThe rise of personalized medicine is another formidable challenge. Treatments like autologous cell therapy, which involves extracting and cultivating the patient's cells before reintroducing them, require highly customized approaches. Each patient essentially represents a batch size of one, making automation difficult and leading to manual, paper-driven processes. This shift from large-scale manufacturing to smaller, lab-like settings demands innovation in bioprocessing equipment and methodologies to maintain efficiency and quality.Cultivating Sensitive CellsAs bioprocessing diversifies, the cultivation of increasingly sensitive cells has become a significant hurdle. Unlike the robust CHO cells, newer cell types require gentler handling and innovative bioreactor designs. Startups like Kolibri, Biothrust, and Green Elephant Biotech are pioneering novel bioreactor technologies to address these needs. From acoustic wave bioreactors to stress-free cultivation conditions and minimal-space cell screws, these innovations aim to provide the optimal environment for sensitive cells to thrive.The Cell as the ProductThe complexity of the products has exponentially grown. While an antibody weighs roughly 150 kDa, a single cell weighs a staggering 10 to the power of 14th Da, making it a billion times more massive. This increase in complexity translates to heightened production challenges, monitoring, and quality control to ensure each cell-based product meets therapeutic standards. The industry must develop refined processes and technologies to manage and scale the production of these intricate cellular products effectively.Accessibility and Cost ChallengesPerhaps the most pressing issue is the prohibitive cost of advanced therapies. Despite the existence of revolutionary treatments for conditions like severe asthma and sickle cell disease, the high price tags render them inaccessible to most patients globally. For instance, in the CAR T cell therapy space, only 21,000 out of an estimated 900,000 eligible patients have received treatment due to financial constraints. Addressing these cost barriers is crucial to expanding the reach of these life-saving therapies.Innovative Approaches and Collaborative EffortsAs discussed in the podcast, industry leaders from academia, small companies, and big pharma are actively seeking solutions to these challenges. Collaborative efforts are essential to drive innovation and reduce manufacturing costs. By focusing on scalable, cost-effective, and high-quality production methods, the industry can move towards wider accessibility of advanced therapies. Ensuring that breakthroughs in bioprocessing translat

Send us a textIn a world of rapid advancements in medical science and biotechnology, bioprocessing is at the forefront of healthcare innovation. Yet, despite remarkable progress, life-saving biotherapeutics remain out of reach for much of the global population.A staggering 80% of patients worldwide lack access to the biotherapeutics they need. While bioprocessing has made impressive strides, the high cost and slow development of these treatments create significant barriers. Addressing these challenges is critical to making innovative therapies widely available.David Brühlmann is launching a special four-part series based on his keynote at the Amphacademy, exploring bioprocessing's revolutionary journey - from the early days of recombinant insulin to today's groundbreaking therapies. This series will also highlight strategies to make these innovations more accessible to patients worldwide.From Standardization to PersonalizationOne major challenge is the shift away from platform technologies. Traditionally, antibodies were produced using standardized CHO cell templates and purification steps, but this approach falls short for new modalities.Personalized therapies further complicate the landscape. Autologous cell therapies, for example, require isolating, cultivating, and reinfusing a patient's own cells. These small-batch processes are labor-intensive, less automated, and often reliant on outdated, paper-driven workflows.Innovations in Bioreactor DesignWith the rise of sensitive cell therapies, bioreactor design must evolve. Unlike CHO cells, these delicate cells require gentler handling environments. Innovations like acoustic wave bioreactors, bionic bioreactors, and specialized cell screws are emerging to optimize cell growth and improve efficiency.The Complexity and Cost of Cell-Based ProductsNew bioprocessing modalities bring greater complexity. Cell-based therapies and cultivated meats are far more intricate than traditional antibody proteins, making scaling production and ensuring quality especially challenging.High production costs further limit access. Even in regions where these therapies are approved, pricing remains a major barrier. Lowering manufacturing costs is essential to democratizing these life-saving treatments.The shift from basic recombinant proteins to complex cell-based therapeutics is just the beginning. Overcoming these challenges - scaling production, reducing costs, and managing complexity - is key to making breakthrough therapies accessible to all.Next step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t

Send us a textThe biotechnology industry is on a transformative path. With emerging technologies and innovative ideas, bioprocessing professionals are poised to revolutionize how therapies are developed and delivered. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann continues his conversation with François Carruzzo, the CTO of Bioscibex, as they delve into the challenges and opportunities present in the biotech landscape.Bioprocess automation boosts efficiency and scalability in therapeutic production. François Carruzzo explores how automation and sensors simplify processes, cut costs, and enhance reliability - key to making biologics more accessible worldwide.Here are some key lessons Carruzzo learned on his entrepreneurial journey:Seeking and Leveraging Advice as a Startup: For biotechnology entrepreneurs, seeking the right advice is a cornerstone for success. Carruzzo discusses the significance of having a scientific advisor. He highlights the value of external perspectives in helping startups navigate strategic decisions, addressing complex challenges, and innovating effectively.The Role of Networking and Ecosystems: Startup ecosystems and networks play an indispensable role in propelling innovations within the biotech industry. Situated in Lausanne, Switzerland, Bioscibex is well-positioned within a dynamic biopharma ecosystem. Utilizing incubators and networking events, Carruzzo underscores the importance of connecting with other innovative organizations and experts, which can accelerate product development and industry relevance.Customer Engagement as a Key Driver for Innovation: Understanding and integrating the voice of the customer is pivotal in product development. Carruzzo emphasizes starting customer interactions early in the development process. Engaging with potential users before launching a prototype allows companies to tailor products that meet user needs and align with market demands.Carruzzo advises biotech entrepreneurs to validate their ideas through market research and pursue them with commitment. He highlights the challenges of innovation but emphasizes its invaluable rewards. By streamlining processes and prioritizing innovation, the biotech industry can drive progress that benefits both companies and patients worldwide.This episode highlights how breakthrough biotech innovations require strategy, regulatory expertise, and customer focus. Bioscibex's journey exemplifies technology's transformative power in the industry.Want to dive deeper into the startup journey and gain insights from entrepreneurs?Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David SchönauerEpisodes 83-84: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens BayerEpisodes 81-82: Regenerating Muscles: The Future of Autologous Cell-based Therapy with Deana MohrConnect with François Carruzzo:LinkedIn: https://www.linkedin.com/in/francois-carruzzoBioscibex: https://bioscibex.comNext step:Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhu