Shows
Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation206: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 2Carbon neutrality goals are everywhere in biopharma. But how do you actually measure and reduce your true environmental impact when data gaps and baseline differences make comparisons so tough?In this episode, David Brühlmann talks with Niklas Jungnelius, Cytiva’s expert in process modeling and sustainability, who’s spent years uncovering what really drives emissions and how small process tweaks can deliver big results.Niklas goes beyond the numbers, challenging assumptions and showing how sustainability becomes a strategic, data-driven advantage. From real-world cases at Cytiva, he explains why recycling plastics may not move the needl...
2025-11-1317 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation205: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 1Your Manufacturing Decisions Are Costing You More Than You ThinkEvery bioreactor decision. Every scale-up choice. Every facility investment. They're all silently writing checks your process might not be able to cash.The difference between a profitable biologics program and one that bleeds capital? Process economic modeling, the analytical framework that reveals exactly where your money goes and why.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann talks with Niklas Jungnelius, Process Modeling Leader at Cytiva, who has spent 25+ years decoding the economics of biologics manufacturing for biotech companies n...
2025-11-1125 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 2Cell and gene therapies are transforming modern medicine, but their path to market is fast and complex. They often jump from small trials to global launch at record speed, putting pressure on analytics, supply chains, and partnerships. Success depends on making smart choices about what to build in-house and what to entrust to expert partners.Daniel Galbraith knows these challenges intimately. With decades of hands-on experience and as Chief Scientific Officer at Solvias, Daniel has witnessed firsthand the seismic shifts in analytical development for advanced therapies. He’s been on every side of the table: troubleshooting manufacturing sn...
2025-11-0620 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation203: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 1Finding an analytical CRO that's truly invested in your success, not just processing samples, makes all the difference in CMC development. In this episode, host David Brühlmann talks with Daniel Galbraith, Chief Scientific Officer at Solvias, about the essential questions and mindset that lead to breakthrough CRO partnerships.With nearly three decades in analytical development, spanning monoclonal antibodies, biosimilars, and cell and gene therapies, Daniel reveals what separates CROs who become true partners from those who just run methods. His insights can save your program months of delays and costly missteps.Key Topics D...
2025-11-0428 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation202: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 2What if the answer to battling antibiotic-resistant infections isn’t a new antibiotic, but harnessing viruses that have been quietly dominating bacterial populations?Bacteriophages, viruses that target and kill bacteria, have been saving lives for a century, but their true potential is only now being unlocked by modern machine learning. The race isn’t just about discovering effective phages; it’s about deploying the right therapy, personalized to the patient, before time runs out.On this episode, David Brühlmann welcomes José Luis Bila, Co-Founder and CEO of Precise Health. Driven by personal tragedy and an engin...
2025-10-3024 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 2Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind.In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at Merck and guiding biotech companies through CMC development, David delivers the process control framework that transforms reactive troubleshooting into predictive manufacturing.
2025-10-2320 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation199: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 1Over 40% of biotherapeutic failures during clinical development stem from stability problems—and most trace back to protein aggregation that could have been prevented. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann exposes the hidden manufacturing crisis that derails promising biologics programs and delivers the systematic Quality by Design framework that elite biotech companies use to build quality into every process step.David brings two decades of bioprocess expertise from his time leading technology innovation at Merck and now guiding emerging biotech companies through CMC development as Managing Director of Brühlmann Consulting. Drawing on F...
2025-10-2121 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation197: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 1What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely?Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to handle.In this deep-dive episode, David Brühlmann sits down with Amanda Hoertz, Vice President of Analytical and Formulation Sciences at KBI Biopharma, where she oversees 300+ scientists across the mammalian n...
2025-10-1425 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation196: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 2What if solving tomorrow’s bioprocessing challenges meant questioning the very physics of chromatography and reimagining downstream processing from the ground up?For years, large biomolecules like viral vectors and exosomes have squeezed through the limitations of traditional chromatography, leaving scientists to wrestle with capacity trade-offs and slow mass transfer. But what if a fundamental shift could unlock breakthroughs for gene therapies, vaccines, and advanced biologics?In this thought-provoking episode, host David Brühlmann sits down with Alois Jungbauer, professor emeritus of downstream processing at BOKU University (Vienna) and scientific advisor at BioChromatographix International. Together, the...
2025-10-0925 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation195: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 1In this episode, host David Brühlmann is joined by Alois Jungbauer, Professor Emeritus at BOKU University, Vienna, and Scientific Advisor at BioChromatographix International. With over 40 years in bioprocess engineering and more than 400 published papers, Jungbauer offers a unique perspective on how downstream processing and purification technologies have evolved and where they’re headed next.Alois shares his unconventional journey into the world of biotech, starting from humble beginnings on an Austrian farm, and discusses key turning points that have shaped the industry. Together, they explore the latest challenges triggered by high cell culture titers, new therapeutic mod...
2025-10-0720 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation194: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 2What if the future of affordable, life-changing cell and gene therapies comes down to one critical yet often overlooked factor: manufacturing efficiency?In advanced therapy medicinal products (ATMPs), groundbreaking science abounds, but the path to the clinic is still strewn with bottlenecks, especially when it comes to cost, complexity, and safety. While the promise is enormous, most therapies remain out of reach for many patients due to high cost of goods and logistical hurdles. What can actually break down these barriers and democratize access?In this episode, David Brühlmann welcomes Lucas Chan, celebrated Fellow o...
2025-10-0219 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation193: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 1Viral vectors are the backbone of cutting-edge cell and gene therapies, delivering life-altering treatments to patients with genetic diseases. But making these biological delivery vehicles is a high-wire act: unpredictable, complex, and fraught with hurdles that traditional biologics manufacturers have never faced.While the world races toward next-generation therapies, the challenge of producing viral vectors at clinical and commercial scale threatens to leave patients waiting on the sidelines.Our guest on the Smart Biotech Scientist Podcast is Lucas Chan, a molecular and cell biologist with over two decades of hands-on experience in cell and gene...
2025-09-3029 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation192: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 2Is continuous manufacturing delivering the transformative results everyone promised, or are you being sold an expensive solution to the wrong problem? While industry headlines tout revolutionary productivity gains, the economic reality behind continuous bioprocessing tells a more nuanced story that every process engineer needs to understand before making capital investment decisions.In this episode, host David Brühlmann continues his conversation with Andreas Castan, Strategic Technology and Business Development Leader at Cytiva, diving deep into the hard economics and operational realities of next-generation manufacturing strategies. Andreas brings over 25 years of bioprocess expertise from upstream innovation t...
2025-09-2519 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation191: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 1What if process intensification could transform your bioprocessing economics without the complexity most engineers fear? Getting 3x productivity gains and 30-150% titer increases once seemed reserved for Big Pharma's endless R&D budgets, but a strategic approach to technology selection is making these results achievable for companies of any size.In this episode, David Brühlmann speaks with Andreas Castan, a bioprocess veteran with over 25 years of industry experience who provides leadership and support to Cytiva's bioprocess business. Andreas brings deep expertise from directing upstream development at Swedish Orphan Biovitrum and extensive work in expression s...
2025-09-2321 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 2Still think you can "figure out CMC later"? Your competitors just implemented a systematic framework that cuts their IND timeline in half while you're still debating whether CMC matters.The founders who file INDs predictably aren't smarter than you. They just stopped gambling with ad-hoc CMC approaches and started executing proven systems. While you're wrestling with technical details in crisis mode, they built systematic advantages that turn regulatory complexity into competitive weapons.In this episode, host David Brühlmann delivers the complete five-step framework that transforms CMC from startup-killer into market advantage. This i...
2025-09-1818 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation189: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 1Think you can crack the science first and worry about CMC when you "need it"? That's exactly how promising therapies die in regulatory limbo while patients keep waiting.Your breakthrough discovery means nothing if it's trapped in CMC chaos. While you're perfecting your molecular mechanism, competitors with inferior science but superior CMC strategy are racing past you to IND filing and ultimately, to patients.In this episode, I, David Brühlmann, your usual host, expose the dangerous delusion that's quietly bankrupting biotech startups: the belief that brilliant science automatically translates to successful drug d...
2025-09-1616 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 2For too long, biotech innovators have viewed biological systems as inherently messy, unpredictable, and full of “black box” mysteries. But what if, armed with the latest digital tools, AI, and cross-disciplinary thinking, you could transform bioprocessing from a series of trial-and-error experiments to a streamlined, proactive design process?Carmen Jungo Rhême is Full Professor at the University of Applied Sciences in Fribourg (HEIA-FR) and Director of the Biofactory Competence Center (BCC). With 17 years in the pharmaceutical industry at companies like Lonza, Merck Serono, UCB Farchim, and CSL Behring, she specializes in bioprocess development, protein purification, scale-up, and t...
2025-09-1124 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation187: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 1Almost every corner of modern medicine and sustainable food production today is facing a massive challenge: how do we outpace drug-resistant “superbugs” and create food for a growing population using fewer resources? The answer, it turns out, may come down to how well we understand and control the biomanufacturing processes underpinning these biomaterials and biomolecules.In this episode, David Brühlmann speaks with Carmen Jungo Rhême, Full Professor at the University of Applied Sciences in Fribourg, Switzerland and Director of the Biofactory Competence Center. With years in the pharmaceutical industry at Lonza, Merck Serono, UCB Farchim, and CS...
2025-09-0921 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation186: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus - Part 2Imagine unlocking a world where designing custom proteins is not only feasible - but faster, smarter, and more powerful than ever before, thanks to artificial intelligence.As the promise of programmable biology takes center stage, AI-driven protein engineering is rapidly moving from theoretical dream to industry standard.In this episode, David Brühlmann sits down with Elise de Reus, co-founder of Cradle, whose ground-breaking platform has become a go-to for luminaries at pharma giants, as well as leaders in agriculture and industrial biotech. Elise’s journey bridges hands-on scientific discovery with entrepreneurial vision, and she’s on...
2025-09-0417 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation185: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus - Part 1For decades, protein design has hinged on painstaking rounds of wet lab mutagenesis and trial-and-error, a process limited not by human ingenuity, but by time and complexity. Yet as the biotech field seeks faster, greener, and more effective solutions for therapeutics and industrial applications, the next leap might not come solely from the lab bench.In this episode, host David Brühlmann explores the frontiers of AI-driven protein engineering with Elise de Reus, co-founder of Cradle. Elise’s journey weaves together a passion for DNA, real-world impact from the dairy industry to synthetic biology, and high-throughput experience at...
2025-09-0224 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho - Part 2What’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 partner...
2025-08-2819 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation183: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho - Part 1Every 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...
2025-08-2624 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation182: Innovating Continuous Bioprocessing with Vibrating Membrane Filtration with Jarno Robin - Part 2What 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 i...
2025-08-2117 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation181: Innovating Continuous Bioprocessing with Vibrating Membrane Filtration with Jarno Robin - Part 1What 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...
2025-08-1925 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation180: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davis - Part 2The 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...
2025-08-1426 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation179: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies - Part 1The 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...
2025-08-1223 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation178: Rethinking Cultivated Meat Production: Scale and Media Optimization Strategies Slashing Manufacturing Costs with Richard Alldread - Part 2The 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 ex...
2025-08-0721 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation177: Rethinking Cultivated Meat Production: Scale and Media Optimization Strategies Slashing Manufacturing Costs with Richard Alldread - Part 1What 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 s...
2025-08-0523 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation176: How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine - Part 2What 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. Sandr...
2025-07-3114 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation175: How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine - Part 1What 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 s...
2025-07-2919 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey - Part 2How 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 b...
2025-07-2420 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation173: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey - Part 1Are 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 a...
2025-07-2222 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation172: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 2Downstream 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...
2025-07-1719 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation171: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 1For decades, chromatographic purification has made use of bead-based diffusion - a reliable but limiting approach, especially as new modalities like gene therapies, mRNA, and viruses 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 Inn...
2025-07-1520 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation170: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 2For 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 t...
2025-07-1024 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation169: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 1What 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 p...
2025-07-0827 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 2The 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 reg...
2025-07-0326 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation167: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 1Ever 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 practic...
2025-07-0115 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 2Have 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...
2025-06-2617 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation165: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 1Have 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-commu...
2025-06-2418 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 2From 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 Ele...
2025-06-1921 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation163: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 1What 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 o...
2025-06-1725 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 2The 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 exten...
2025-06-1215 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation156: The Hidden Economics of Continuous Processing That Most Biotech Companies OverlookThe 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: T...
2025-05-2227 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes EverythingIn 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 c...
2025-05-2025 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation152: Is an Indian CDMO the Right Move for Your Biologics Pipeline? with Abdelaziz Toumi - Part 2Is 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...
2025-05-0821 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation151: Is an Indian CDMO the Right Move for Your Biologics Pipeline? with Abdelaziz Toumi - Part 1Is 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 p...
2025-05-0628 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation150: How to Leverage AI in Media Development Without Sacrificing Process Understanding with Tom Fletcher - Part 2As 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 s...
2025-05-0125 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation149: How to Leverage AI in Media Development Without Sacrificing Process Understanding with Tom Fletcher - Part 1From 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 o...
2025-04-2918 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation145: Beyond ELISA: The 10-Minute Immunoassay Enabling Real-Time Bioprocess Control with Bruno Oesch - Part 1Tired 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...
2025-04-1529 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation144: The Future of Biotech: Making Biotherapeutics More Accessible FasterImagine 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-m...
2025-04-1012 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation143: Bioprocess Breakthroughs: How Smart Bioprocessing Is Democratizing Life-Saving TreatmentsIn 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 b...
2025-04-0815 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation141: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor - Part 1The 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...
2025-04-0126 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 2In 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...
2025-03-2720 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation139: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 1In 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.
2025-03-2527 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation137: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint - Part 1The 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 Y...
2025-03-1821 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)Sickle cell disease affects thousands with severe daily pain. While FDA-approved gene therapies exist, their $2.2 million cost per treatment makes them largely inaccessible.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann explores five key challenges facing the bioprocessing industry in making these therapies more accessible:Moving Away from Platform TechnologiesTraditional bioprocessing relies on platform technologies for antibody production. However, new therapies require more flexible, adaptable systems that can accommodate novel modalities.Increased Personalization and Smaller Batch SizesPersonalized medicine, especially a...
2025-03-1313 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation135: Beyond Breakthroughs: Making Biotherapeutics Affordable for AllIn 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 rev...
2025-03-1112 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation134: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 2The 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.Her...
2025-03-0616 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation131: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 1The real-world applications of AI in biomanufacturing are transformative. From reducing drug development timelines to optimizing production yields, AI is making biomanufacturing more efficient and cost-effective. This, in turn, enhances global access to life-saving therapies. As AI continues to evolve, its potential to drive even greater innovations in biologics manufacturing becomes increasingly promising.In the latest episode of the Smart Biotech Scientist Podcast, David Brühlmann speaks with Reza Farahani, founder and CEO of Catalyze AI, about the profound impact of AI on biomanufacturing. They discuss how AI is reshaping drug development, reducing costs, and simplifying complex b...
2025-02-2528 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 2The intricacies of tech transfer and the challenges of scaling manufacturing processes are often underestimated in the biotechnology industry. Understanding these complexities is crucial for translating innovative scientific breakthroughs into commercially viable products.In the second part of the conversation with Jason Foster, CEO of Ori Biotech, host David Brühlmann explores the complexities of cell therapy manufacturing. Their discussion highlights key challenges, including tech transfer, scale-out strategies, and the crucial role of commercial strategy alongside scientific excellence.Jason also revealed a groundbreaking approach in the cell therapy space. He detailed how Ori's IRO® platform ca...
2025-02-2020 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation127: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily - Part 1In the fast-paced and highly regulated world of biotech development, maintaining an innovative spirit can sometimes feel like a Herculean task. Between optimizing cell culture processes and navigating strict regulatory requirements, it’s no wonder many scientists feel the weight of daily operations pressing down on their creativity. However, fostering innovation is crucial for breakthroughs in our field.David Brühlmann shares practices that have transformed how scientists approach complex challenges in our field.Here are the first four habits that can reshape your approach to bioprocess development.Cultivate Deep Curiosity: Curiosity is...
2025-02-1115 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei - Part 2As biotechnology rapidly evolves, cell therapies are emerging as a groundbreaking frontier with the potential to transform medicine. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Armon Sharei, founder and CEO of Portal Bio, about the complexities, challenges, and future of cell therapies.Cell therapies could revolutionize medicine in ways similar to antibiotics and vaccines. However, the current manufacturing process is costly and time-consuming.Armon Sharei envisions a future where point-of-care production makes these therapies more accessible, even at the patient's bedside. This approach could not only benefit d...
2025-02-0620 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation125: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei - Part 1Intracellular delivery is essential for advancing research and clinical applications, yet it presents unique challenges when working with different cell types and biomolecules.In a recent episode of the Smart Biotech Scientist podcast, David Brühlmann spoke with Armon Sharei, the founder and CEO of Portal Bio, about the future of cell therapy, the hurdles of intracellular delivery, and groundbreaking innovations in drug screening.Armon’s journey began at MIT, where his initial focus on chemical engineering evolved into a passion for cell engineering. While exploring innovative methods for introducing materials into cells, he discovered a n...
2025-02-0421 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 2In the second part of this conversation on digital solutions in bioprocessing, David Brühlmann and Simon Wieninger, Business Manager Digital Solutions at Eppendorf Group, discuss real-world examples of labs revolutionizing their workflows through smart digitalization. From real-time data monitoring to intercontinental data sharing, Simon highlights the practical benefits and exciting future potential of digital technologies in bioprocessing.Missed Part 1? In the previous episode, Simon Wieninger from Eppendorf Group addressed data silos, cloud technology, and security in biotech. Catch up on that episode before diving into Part 2!Key highlights from the episode:Choosing t...
2025-01-2317 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation121: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger - Part 1Digital transformation is reshaping industries worldwide, and biotech is no exception. With the integration of cloud technologies, AI, and data harmonization, bioprocessing is becoming smarter, more efficient, and more innovative. Catching up with digital revolutions in other sectors, biotech now stands at the threshold of tremendous change.In this episode of the Smart Biotech Scientist Podcast, David Brühlmann sat down with Simon Wieninger, Business Manager Digital Solutions at Eppendorf Group, to discuss the digital revolution sweeping through bioprocessing labs. From bioreactors to data lakes, Simon sheds light on the urgent need for a data-driven approach in b...
2025-01-2124 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo - Part 2In the ever-evolving world of biotechnology, the integration of artificial intelligence (AI) and synthetic biology is driving unprecedented advancements. This transformative power was the focus of this podcast episode of the Smart Biotech Scientist, where host David Brühlmann engaged in a thought-provoking conversation with Haotian Guo, CEO and Founder of Ailurus on the role of AI in bioprocessing, the significance of wet lab validation, and the exciting future of programmable biology.The conversation with Haotian Guo sheds light on the profound impact AI is having on the field of biotechnology. AI's role as a "co-pilot" in s...
2025-01-1621 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation119: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo - Part 1Biotechnology is rapidly evolving as innovation addresses real-world needs. At the cutting edge of this evolution, synthetic biology and AI-driven protein design are revolutionizing our approach to complex processes like protein purification.In this episode of the Smart Biotech Scientist podcast, host David Brühlmann talks with Haotian Guo, CEO and Founder of Ailurus, about the modern advancements in synthetic organelles and their transformative impact on protein purification.Haotian Guo introduces a groundbreaking approach inspired by nature’s processes. Instead of relying solely on chromatography, synthetic biology mimics how organelles in cells, like beta cells pur...
2025-01-1419 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation115: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti - Part 1Bioprocess development is transforming the biotech industry, driving innovations in life-changing therapies. Success hinges on simplifying complex mechanisms and adopting advanced technologies. By integrating high-throughput screening and artificial intelligence, we can streamline workflows, reduce trial-and-error, and speed up biologics development. Embracing cutting-edge tools empowers scientists to maximize biology's potential, delivering efficient and impactful biotech solutions.In this episode of The Smart Biotech Scientist Podcast, host David Brühlmann explores these transformative methodologies with Jeremy Agresti, CTO and founder of Triplebar.Jeremy highlights the future of bioprocessing at the intersection of high-throughput screening, miniaturization, and AI. W...
2024-12-1719 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer - Part 2In this captivating episode, we dive deep into the groundbreaking intersection of artificial intelligence and enzyme engineering with David Schönauer, founder and CEO of Aminoverse.From university lab benches to pioneering AI-driven enzyme discovery, David shares how his startup is transforming the biotech landscape by making enzyme development faster, more predictable, and increasingly efficient.Highlights:Discover how AI is revolutionizing enzyme prediction and design, potentially reducing development time from years to weeksLearn why high-quality wet lab data remains crucial for AI success in biotech, and how Aminoverse's unique approach combines both worldsGain insights i...
2024-11-2128 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation107: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer - Part 1Ever wondered how scientists find the perfect enzyme among billions of possibilities? In this fascinating episode of the Smart Biotech Scientist podcast, host David Brühlmann sits down with David Schönauer, CEO of Aminoverse, who's revolutionizing enzyme engineering through artificial intelligence.As a biotech entrepreneur who transformed his academic passion into a groundbreaking startup, Schönauer shares how his company is solving one of biotechnology's biggest challenges: efficiently identifying the right enzyme for specific applications, from pharmaceutical manufacturing to sustainable consumer products.Key Takeaways:Discover how Aminoverse's innovative platform navigates through mor...
2024-11-1919 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation103: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa - Part 1In this insightful episode, we're joined by Sigma Mostafa, Chief Scientific Officer at KBI Biopharma, who shares crucial insights on selecting the right CDMO partner for biotech development.Sigma brings a unique blend of scientific rigor and practical experience to the discussion, having worked on both sides of the CDMO relationship.Key Takeaways:Why harvest steps deserve more attention in bioprocess developmentThe truth about one-stop-shop CDMOs versus specialized partnersCritical factors in cell line and media selection that impact long-term successSigma emphasizes that successful CDMO partnerships hinge on transparent communication and cultural alignment...
2024-11-0525 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation101: PAT Revolution: Decoding Your Bioprocess Like Never Before with Katharina Dahlmann - Part 1Unlock the hidden potential of your bioprocess! In this eye-opening episode, David Brühlmann sits down with Katharina Dahlmann, Application and PAT Expert at Hamilton, to explore the game-changing world of Process Analytical Technology (PAT).Discover how PAT is revolutionizing biotech by providing unprecedented insights into cell behavior and process dynamics. Katharina challenges conventional wisdom, revealing that what we think we know about our processes may just be the tip of the iceberg. Learn how combining multiple PAT signals can extract meaningful knowledge, leading to more reproducible and efficient processes.You will gain valuable insights o...
2024-10-2924 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation97: The Biomanufacturing Revolution: Bringing Game-changing Products to Market with James Ryall - Part 1In this captivating episode, host David Brühlmann welcomes James Ryall, a strategic consultant with over two decades of experience in cell biology and regenerative medicine. From his groundbreaking work in skeletal muscle research to revolutionizing cultured meat production, James shares his fascinating journey through academia and industry.Discover how he's now helping biotech startups align their technical strategies with commercial outcomes, accelerating their path to market.You will gain invaluable insights on:Navigating the transition from academia to industryScaling cell production from lab quantities to industrial volumesIdentifying and pivoting to the right target m...
2024-10-1526 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma Alispahic - Part 2Are you ready to revolutionize your bioprocess development? Join David Brühlmann as he interviews Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode, who unveils the game-changing potential of AI in biopharma.Discover how AI is transforming the industry, from drug discovery to manufacturing, and learn why it's no longer optional but essential for success.Key takeaways:Leverage AI to streamline experiments, reduce costs, and accelerate your path to marketGain insights into emerging AI technologies reshaping biopharma's futureLearn practical steps to integrate AI into your workflow, even with limited resourcesDon't miss t...
2024-10-1019 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation93: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer - Part 1Discover how a failed optometry dream led Benjamin McLeod to become a leading voice in cell and gene therapy. In this eye-opening episode, Ben, who is a Cell & Gene Therapy Segment Lead at NanoMosaic, shares his unconventional path from lab work to LinkedIn stardom, revealing how he bridges the gap between R&D and marketing in biotech.Learn how Ben's weekly science memes evolved into valuable content that attracts both lab techs and CEOs alike.Key takeaways:Gain insider tips on communicating complex science effectivelyLearn how to leverage social media to build industry credibilityDiscover...
2024-10-0125 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation90: Scale-Up Secrets: Cracking the Code of AAV Production with Ahmed Youssef - Part 2Dive into the cutting-edge world of gene therapy as we unravel the complexities of AAV production. In this insightful episode, Ahmed Youssef, a seasoned AAV expert and Senior Process Development Manager at Ascend, explains how you can navigate the complex world of AAV scale-up and learn why thinking outside the box is crucial for success.Key takeaways:Leverage early expert advice to ensure your therapeutic's long-term viabilityExplore innovative technologies like doggy bone DNA to reduce impuritiesGain insights from industry pioneers to revolutionize your AAV production processFrom plasmid alternatives to cutting-edge CDMO strategies, this episode...
2024-09-1926 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation88: The Swiss Army Knife of Biotech: Unleashing the Power of Fractional ExpertiseUnlock the secret weapon of biotech success! In this eye-opening episode, host David Brühlmann reveals how fractional CTOs are revolutionizing drug development, inspired by Michael Jordan's approach to greatness. Learn how this innovative strategy can slash timelines, mitigate risks, and give your biotech company a competitive edge.Discover the game-changing benefits of fractional expertise:Gain rapid access to broad biotech knowledge, navigating complex challenges with ease.Slash costs while tapping into C-level strategic guidance for critical growth phases.Accelerate business development through valuable industry connections and insights.Ready to transform your biotech journey? Tune i...
2024-09-1216 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation87: The Hidden Pitfalls of Bioprocess Development: Lessons from the TrenchesUnlock the secrets of successful bioprocess development with host David Brühlmann as he shares hard-won lessons from his 15+ years of experience leading technology transfers and technology innovation projects.Discover why prioritizing process development is crucial for transforming groundbreaking science into life-changing therapies. In this eye-opening episode, you'll learn:How to avoid costly mistakes in technology transfer and scale-up, saving you time and resourcesStrategies for balancing investor expectations with regulatory hurdles, keeping your project on trackTips for building a robust risk management strategy that impresses investors and navigates challengesFrom selecting the right cell lines t...
2024-09-1016 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli - Part 2What if your biomanufacturing facility could run itself, optimize its own processes, and operate non-stop? This isn't science fiction – it's the cutting-edge reality Professor Massimo Morbidelli is helping to create.In this captivating episode, the bioprocessing pioneer unveils how AI, continuous manufacturing, and revolutionary machine learning techniques are transforming the industry landscape.As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bi...
2024-09-0524 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation85: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli - Part 1Imagine a world where biologic drugs are produced faster, cheaper, and with unprecedented precision.In this episode, we dive into that future with Professor Massimo Morbidelli, a trailblazer in bioprocessing innovation. As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bioprocesses (CoDiBio) at the Aristotle University of Thessaloniki.From his groundbreaking work in continuous chromatography to spearheading AI-driven manufacturing, Morbidelli's 25-year...
2024-09-0325 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation84: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens Bayer - Part 2Are your shake flasks holding back your bioprocess development? Discover how to transform them into smart bioreactors! In this game-changing episode, we talk with Jens Bayer about the groundbreaking DOTS platform. He is a deep tech entrepreneur and seasoned commercial leader, currently serving as Chief Commercial Officer at Scientific Bioprocessing.Jens reveals how this cutting-edge technology is bridging the gap between simple shake flasks and complex bioreactors, offering scientists unprecedented control and data insights.Learn how to:Generate real-time growth curves and monitor key parameters without invasive samplingRun fed-batch experiments in shake flasks, mimicking...
2024-08-2925 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation79: Think Before You Build: Holistic Approaches to Biotech Facility Design with Alfredo Martínez Mogarra - Part 1Ever wondered what it takes to build a large-scale biotech manufacturing facility? Alfredo Martínez Mogarra, a seasoned Bioprocess Engineer with over 30 years of experience and Chief Operations Manager at VIVEbiotech, reveals the secrets behind successful biotech facility design and scale-up. He has been at the forefront of transforming bench processes into industrial realities.In this eye-opening episode, Alfredo shares critical insights on navigating the complex world of biotech manufacturing. Listeners will gain:A deep understanding of the key factors in designing efficient biotech facilitiesStrategies to mitigate risks when scaling up processesTips for fostering successful interdisciplinary c...
2024-08-1326 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation76: Transforming Single-Cell Analysis With Impedance Flow Cytometry w/ Furkan Gökçe - Part 2Curious about the latest innovations in cell analysis technology? Join us in this episode with Furkan Gökçe, New Business Development Manager at Amphasys, as we delve into the fascinating world of Impedance Flow Cytometry (IFC).Furkan shares how IFC is revolutionizing single-cell analysis by providing faster, more precise, and high-resolution data.Key Takeaways:Real-Time Precision: Discover how IFC allows for real-time, label-free assessments of cells, providing detailed insights into their natural state.Enhanced Process Control: Learn how IFC can detect early signs of nutrient deficiencies and contaminants, leading to timely interventions and im...
2024-08-0125 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation68: How Process Mapping Transforms Knowledge Management in Biotech w/ Irwin Hirsh - Part 2Join us as we explore the pivotal role of process mapping in biotech knowledge management. Our guest, Irwin Hirsh, a seasoned biotech consultant concentrating on enhancing business efficiency and effectiveness, shares invaluable insights into leveraging technology to streamline operations.Key Insights:Identifying Critical Process Knowledge: Learn strategies to identify and manage vital process knowledge essential for optimal performance.Transitioning from Implicit to Explicit Knowledge: Discover why converting hidden, tribal wisdom into structured, accessible information is crucial for scalability and continuity.Harnessing Digital Tools: Explore effective approaches to digital transformation, ensuring seamless integration and collaboration across teams...
2024-07-0430 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation65: Freezing and Thawing Cells: the Science Behind Cryopreservation w/ Mark Davison - Part 1Picture a world where we can freeze cells and bring them back to life perfectly intact.In this episode, we're joined by Mark Davison, a leading expert in cryopreservation and CEO of Grant Instruments to uncover the intricate science of freezing and thawing cells. From basic principles to advanced techniques, we delve into how cryopreservation is revolutionizing biotechnology and cell therapies.Key Takeaways:Cell Survival Secrets: Discover why water is both a friend and foe in preserving cell viability, and how precise control over freezing rates can prevent cell damage.Advanced Techniques: Learn about...
2024-06-2525 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation63: Why Sound Waves Are the Future of Gene Therapy Bioreactors w/ Gabriel Dumy - Part 1Are sound waves the key to revolutionizing gene therapy? In this groundbreaking episode, we sit down with Gabriel Dumy, CTO and Co-founder at Kolibri, a company revolutionizing the way we grow and engineer cells at scale using acoustic waves.Gabriel shares the challenges facing modern bioproduction and unveils an exciting solution that's setting the stage for the future of gene therapy.Key Takeaways:Enhanced Cell Productivity: Discover how acoustic waves minimize shear stress, significantly boosting mammalian cell productivity and density.Versatile Bioreactor Design: Learn about a cell-agnostic technology that seamlessly adapts to various cell...
2024-06-1827 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 2Dive into the realm of biotech with our latest episode as we unravel the enigma of Quality by Design (QbD) with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Discover how integrating QbD principles early in your development cycle can revolutionize your approach to producing safe, high-quality products consistently. From understanding critical quality attributes to designing robust manufacturing processes, we illuminate the transformative potential of QbD.Key Takeaways:Harnessing QbD principles empowers biotech companies to design quality into processes, fostering a deeper understanding of critical parameters and ensuring p...
2024-05-3019 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation57: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 1Join us for an insightful episode as we dive into the world of bioprocess CMC development strategies with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Matthias shares his wealth of knowledge on avoiding common pitfalls in developing robust Chemistry, Manufacturing, and Controls (CMC) strategies. He also emphasizes the critical elements that ensure your biotech product's success.Key Takeaways:Start Strong: Establishing a comprehensive CMC plan early can prevent costly and time-consuming issues later.Leverage Expertise: Bringing in external CMC consultants early o...
2024-05-2817 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation52: Unraveling the Complexity of Commercializing Cell and Gene Therapies w/ Wajiha Ali - Part 2Does the process of commercializing cell and gene therapies seem complex and unclear to you?Dive deep into the groundbreaking world of cell and gene therapies with our guest, Wajiha Ali, a strategy expert who believes in bridging the gap between research and commercialization with data, as we unravel the complexities of bringing life-saving therapies to patients.From cutting-edge technologies to innovative collaboration models, we explore the future landscape of these transformative treatments.You’ll get:An understanding of how partnerships between academic centers, pharma companies, and regulators can decrease development costs an...
2024-05-0927 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation46: From Lab to Table: The Science Behind Cultivated Meat w/ Petra Hanga - Part 2Dive into the future of food with our latest episode, "From Lab to Table: The Science Behind Cultivated Meat." With our guest, Petra Hanga, a Lecturer in Biochemical Engineering at University College London and Chief Scientific Officer of Quest Meat Ltd., we unravel the secrets behind this groundbreaking technology.Key highlights:1. Discover how stem cells revolutionize the production of cultivated meat, providing a scalable solution for creating muscle, fat, and connective tissues.2. Explore the intricate balance of nutrients, growth factors, and environmental conditions crucial for maximizing cell growth and quality.3. Understand...
2024-04-1827 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation39: Balancing Perfusion Process Development and Sustainability w/ Jochen Sieck - Part 1Explore perfusion processes and sustainability with our guest, Jochen Sieck, Director of Cell Culture Media and Process Development at Merck Life Science.Learn about the evolution of perfusion methodologies, its historical roots in addressing product stability, and its recent return to continuous and integrated manufacturing.Jochen discusses the economic and strategic reasons behind perfusion's resurgence, emphasizing the need for flexible, smaller-scale facilities.Key Learnings:Gain insight into the environmental impact of traditional facilities and the potential benefits of alternatives.Dive deep into the balance of cost, productivity, and sustainability in media consumption...
2024-03-2625 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation29: From Monoclonals to Gene Therapy: Tips for Biopharma Process Development w/ Neil Templeton - Part 1In this enlightening episode, we're joined by Neil Templeton, Director in Upstream Process Development at Solid Biosciences, who pulls back the curtain on the intricate world of bioprocess development and manufacturing.Neil delves into the shifting paradigms of the industry, sharing his expert insights on overcoming the unique challenges that surface when transitioning from R&D to GMP production. This episode is packed full of invaluable knowledge that's crucial for anyone looking to succeed in this field.Key points we discuss include:Strategies and solutions for overcoming the obstacles faced when transitioning from R...
2024-02-2025 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation24: Strategies for Success: Master CMC Development with Gene Lee - Part 2If you've ever wondered how to seamlessly transition from R&D to process development, this is your golden ticket. Uncover practical strategies and expert advice that can be your compass through the intricate landscape of mastering CMC development.Uncover the challenges and tactics to seamlessly navigate this critical phase.Conduct Early Developability Assessments: By assessing productivity, aggregation propensity, and manufacturability early on, you can strategically avoid future roadblocks.Use a Platform: A platform approach facilitates swift and cost-effective transitions to clinical trials, reducing pre-proof of concept investment.Bridge the R&D and Process Development Gap: Navigating...
2024-02-0122 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation23: Strategies for Success: Master CMC Development with Gene Lee - Part 1Embark on a journey into the intricate world of CMC development with our latest episode, unraveling the challenges that often baffle biotech scientists. The complexity of CMC development is a formidable hurdle, and in this insightful discussion, we delve into strategies to master this critical process.Key Takeaways:Start Early: Learn how starting CMC development early, even without a complete understanding of your drug, can reduce risks and prepare you better for clinical milestones.Collaborate: CMC development should not work in isolation but integrate insights from diverse teams for a comprehensive drug development strategy.Adopt a...
2024-01-3018 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation11: From Lab to Patient: Steve Oh’s Guide to Mastering Cell Therapy Process Development - Part 1Dive into the world of cell therapy process development with Steve Oh, former Institute Professor at the Bioprocessing Technology Institute (BTI) at the Agency for Science and Technology (A*STAR) and now Scientific Advisor to several international companies, as he shares thought-provoking perspectives and predictions on technologies that will impact the biotech industry.In this riveting conversation, Steve Oh unveils secrets to consistent bioproducts and forecasts the future of cell and gene therapy.Gain a deeper understanding of the evolving landscape and the challenges and opportunities it presents.Key Takeaways:The Power...
2023-12-0527 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation04: How to Master Biotech Scale-up Without Guesswork w/ Leonardo Sibilio - Part 2In today's episode, we continue our fascinating conversation with Leonardo Sibilio, CEO of Biotech Academy and CSO at BetaPro Consulting. We delve into the pivotal role of structured training in the dynamic biotech industry.In this episode, you'll discover:- Foundation of Success: Leonardo emphasizes the importance of a strong foundation in GMP and an understanding of biotech facility operations. Whether you're an aspiring employee or a seasoned professional, a solid knowledge base in these areas is the cornerstone of a successful career.- Broaden Your Horizons: Biotech is...
2023-11-0914 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation03: How to Master Biotech Scale-up Without Guesswork w/ Leonardo Sibilio - Part 1In this captivating episode, we delve into the world of biotech scale-up with the seasoned expert, Leonardo Sibilio, CSO at BetaPro Consulting and CEO of the Biotech Academy in Rome.Discover how mastering the art of biotech scale-up can transform your journey from doubt to dominance.Key Takeaways:1. Early Planning is Paramount: Leonardo emphasizes the importance of initiating the scale-up process as early as possible. Waiting until later phases can lead to challenges and hinder progress. Early planning, including characterizing the cell line and ensuring stability, is key to a seamless transition from...
2023-11-0718 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation01: Unlock the Power of Rational Media Design in Bioprocessing w/ Tom Fletcher - Part 1In this episode with Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific, we delve into the world of bioprocessing. Tom shares insights into the transformative power of rational media design.From the complexities of bioprocess development to the game-changing potential of AI, this interview is a treasure trove of knowledge for both scientists and engineers.You will learn:- Learn about the evolution of priorities during bioprocess development, from speed to reliability, and how scientists must adapt accordingly.- Discover the importance of a thoughtful, hypothesis-driven approach compared to...
2023-11-0719 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation02: Unlock the Power of Rational Media Design in Bioprocessing w/ Tom Fletcher - Part 2Welcome to a fascinating Smart Biotech Scientist episode! In this conversation, we dive deep into the nuts and bolts of rational media development with our guest, Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific.Together, we explore the immense potential of Rational Media Design and how it's transforming the industry.Here are three major takeaways from this episode:1. Define Your Goals: Tom emphasizes the importance of clearly defining your bioprocessing goals. Whether it's boosting cell growth or enhancing product quality, understanding your specific needs is the first crucial step.
2023-11-0718 min