Shows
Smart 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 R&D leader at Sani Membranes. With two decades of experience implementing...
2025-08-2115 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...
2025-08-0720 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...
2025-07-2418 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...
2025-07-2221 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...
2025-07-1022 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...
2025-07-0826 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...
2025-07-0113 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...
2025-06-1919 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...
2025-04-1528 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 Innovation142: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor - Part 2What 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...
2025-04-0317 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.
2025-03-2526 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation138: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint - Part 2In 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...
2025-03-2020 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 Innovation132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 2Artificial Intelligence (AI) is transforming industries worldwide, and biotechnology is no exception. In bioprocess development, AI is proving to be a game-changer, accelerating workflows, optimizing processes, and driving innovation. On the Smart Biotech Scientist Podcast, Reza Farahani, founder and CEO of Catalyze AI, shares his insights on how AI is reshaping biomanufacturing and the future of the industry.As AI continues to integrate into bioprocessing, the role of scientists is evolving. Farahani envisions a future where scientists collaborate with AI to enhance efficiency. One of Catalyze AI’s exciting innovations is an agentic root cause analysis tool, de...
2025-02-2714 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...
2024-11-2127 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 Innovation104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa - Part 2Want to peek behind the curtain of a leading Contract Development and Manufacturing Organization (CDMO)? In this inspiring episode, KBI Biopharma's Chief Scientific Officer Sigma Mostafa reveals the intricate world of bioprocess development and manufacturing.Sigma shares game-changing insights into accelerating biologics development without compromising quality. She also unveils how KBI is leveraging AI and machine learning to revolutionize everything from protein sequence analysis to formulation development.Key Takeaways:Learn how to master the art of seamless tech transferDiscover how to slash development timelines using innovative cell line technology and parallel processingLearn...
2024-11-0717 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...
2024-10-1525 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 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 Innovation72: Effective Outsourcing: How Small Biotech Companies Can Thrive w/ Mark Melville - Part 2How do small biotech companies make strategic decisions with limited resources? This episode dives deep into the art of prioritization and outsourcing to achieve success.Join us as we speak with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, a seasoned biotech scientist with years of experience in both large and small biotech companies. Mark shares his invaluable insights on navigating the complexities of bioprocess development and outsourcing.In this episode, we explore:Discover the secrets to prioritizing projects for maximum impactLeverage outsourcing for flexibility and expertiseLearn to build strong relationships with...
2024-07-1821 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation71: Effective Outsourcing: How Small Biotech Companies Can Thrive w/ Mark Melville - Part 1Are you navigating the complex world of bioprocess CMC development and manufacturing in a small biotech company?Our latest episode is a must-listen! Join us as we sit down with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, who shares invaluable insights on overcoming the unique challenges faced by small biotech firms.In this episode, we explore:The critical communication strategies needed for successful outsourcing to CDMOs.How small biotechs can leverage their agility to make fast, impactful decisions.The surprising benefits of wearing multiple hats and fostering cross-functional expertise.Tune...
2024-07-1618 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 Innovation49: Decode Bioprocess Success: The Art of Stakeholder Management - Part 1In this episode, we embark on a journey to uncover the essential strategies for navigating stakeholder relationships in bioprocess CMC development projects.We delve into the critical role of stakeholders in bioprocess development and how their engagement can determine the success or failure of a project. Drawing from real-life experiences and insights, we explore the importance of understanding stakeholder needs, interests, and power dynamics.Discover why stakeholder management is not just a skill but an art form essential for unlocking bioprocess success. Join us as we unravel the complexities of stakeholder engagement and provide actionable...
2024-04-3017 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation42: Revealing the Disciplined Pursuit of Less in Bioprocessing - Part 2Hey, fellow scientists! Do you find yourself buried under an avalanche of tasks, unsure which one truly matters? If you're tired of the chaos and want to reclaim control of your time and energy, stick around.Today, we're unlocking the secrets of Essentialism, tailor-made for busy biotech scientists like you. We discuss the importance of focusing on the vital few tasks that contribute significantly to your goals, celebrating small wins, and protecting your time.We also share a powerful story that illustrates the potential of Essentialism. Discover how Essentialism is not about doing more, but...
2024-04-0413 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation41: Revealing the Disciplined Pursuit of Less in Bioprocessing - Part 1Hey, fellow scientists! Do you find yourself buried under an avalanche of tasks, unsure which one truly matters? If you're tired of the chaos and want to reclaim control of your time and energy, stick around.Today, we're unlocking the secrets of Essentialism, tailor-made for busy biotech scientists like you. We discuss the importance of focusing on the vital few tasks that contribute significantly to your goals, celebrating small wins, and protecting your time.We also share a powerful story that illustrates the potential of Essentialism. Discover how Essentialism is not about doing more, but...
2024-04-0215 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation33: The 7 Habits of Highly Successful Innovators - Part 1Uncover the secrets of successful innovators, including Steve Jobs, Elon Musk, and Thomas Edison, in this enlightening episode of our podcast. We dive deep into the habits that set these trailblazers apart and fuel their innovative spirit.Key learnings include:The power of curiosity and how it leads to groundbreaking ideas and improvements.The importance of connecting the dots to gain new insights and see invisible relationships.The role of risk-taking in pushing boundaries and experimenting with new ideas.These insights provide a roadmap to developing your own innovative mindset and achieving success. Don't miss...
2024-03-0511 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation32: The Future of Glycoengineering: Trends Unveiled w/ Thomas Rexer - Part 2Discover the hurdles and breakthroughs in glycoengineering, including the high costs of activated sugars.Thomas Rexer, CTO of eversyn, a spin-off of the Max Planck Institute Magdeburg, unveils eversyn's multi-step biocatalysis process, designed to significantly drive down costs and make in vitro glycoengineering more accessible on a large scale.Key Insights:Uncover the power of multistep biocatalysis in driving down costs and making in vitro glycoengineering more accessible.Bridge the Gap between academia and industry in glycoengineering and thus ensure a smoother integration of groundbreaking glycoengineering technologies into the industrial landscape.Gain valuable insights...
2024-02-2917 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation31: The Future of Glycoengineering: Trends Unveiled w/ Thomas Rexer - Part 1Get ready for a crash course in glycoengineering as Thomas Rexer, CTO of eversyn, a spin-off of the Max Planck Institute Magdeburg, breaks down the significance of modifying glycans in biopharmaceuticals.Explore the science behind glycoengineering and its potential to enhance the properties of therapeutic proteins.Key Insights:Unlock new frontiers in glycoengineeringExplore the potential of glycoengineering to revolutionize biopharmaceuticalsEnsure seamless integration of glycoengineering into production processesDon't miss this episode as Thomas unveils the trends that will shape the future of glycoengineering, offering actionable insights for scientists, entrepreneurs, and biotech enthusiasts alike.
2024-02-2718 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation30: From Monoclonals to Gene Therapy: Tips for Biopharma Process Development w/ Neil Templeton - Part 2In our insightful second part of the conversation, we broaden our perspective to delve into the various modalities within the biotech industry, highlighting the unique and shared aspects of process development and scale-up.Neil Templeton, the Director of Upstream Process Development at Solid Biosciences, passionately articulates his commitment towards making gene therapy more accessible. He does this by outlining strategic solutions to reduce the costs of development and manufacturing.You will gain:A comprehensive understanding of process development's similarities and differences across biologics, vaccines, and cell and gene therapy manufacturing.Effective strategies aimed at...
2024-02-2214 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...
2024-02-2024 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation28: How to Simplify Project Management in Bioprocess Development - Part 2Tackling bioprocess development and scale-up can be complex. While the science might be challenging, project management within biotech doesn't have to be.In this engaging episode, we'll guide you on how to streamline your CMC development, demystifying the complexities of project planning and execution.Here's what you'll gain:Discover the secret to 'Successful Planning,' - a strategy to ensure your projects are well-organised, resource-smart, and timely delivered.Understand the crucial role of 'Assessing Scalability Potential,' and why it's a game-changer for your project's long-term success.Unleash the 'Power of a High-Performance Team...
2024-02-1512 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation27: How to Simplify Project Management in Bioprocess Development - Part 1Bioprocess development and scale-up are complex. Science may give you headaches, but biotech project management should not.In this riveting episode, you'll learn how to simplify your CMC development, guiding you through the maze of project planning and execution.Key Takeaways:Uncover how to "Plan for Success," ensuring your projects are well-structured, resource-efficient, and delivered on time.Learn the importance of "Evaluating the Scalability Potential," and why it's crucial for the long-term success of your project.Discover the power of "Building a High-Performing Team," and how the right leadership can empower your team and...
2024-02-1315 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation26: 9 Critical Steps for a Seamless Transition to Large-Scale Production - Part 2In this riveting episode of the Smart Biotech Scientist podcast, we navigate the intricate labyrinth of biotech scale-ups. We distill the process down to 9 essential steps for a smooth transition from laboratory to large-scale production.Key Insights:Acquire Comprehensive Process Understanding: Bolster your decision-making and problem-solving skills with an in-depth understanding of your process, molecule, and expertise at your disposal.Span the Technology Gaps: Tackle obstacles and boost efficiency by utilizing appropriate technology and strategic risk mitigation techniques.Develop a Detailed, Sequential Roadmap: Alleviate confusion and ensure a fluid scale-up process with a precise, well-defined roadmap.
2024-02-0812 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation25: 9 Critical Steps for a Seamless Transition to Large-Scale Production - Part 1In this enlightening episode of the Smart Biotech Scientist podcast, we delve into the complex world of biotech scale-ups. We break down the 9 crucial steps to ensure a seamless transition from lab to large-scale production.Top 3 Takeaways:Gain Comprehensive Process Understanding: Enhance your decision-making and problem-solving abilities by thoroughly understanding your process, molecule, and available expertise.Bridge the Technology Gaps: Overcome challenges and increase efficiency by leveraging suitable technology and strategic risk mitigation methodologies.Create a Clear, Step-by-Step Roadmap: Reduce confusion and facilitate a smooth scale-up process with a clear, detailed roadmap.You will be...
2024-02-0618 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 Innovation22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin Kawamata - Part 2Are you looking for advanced strategies to enhance the quality and efficiency of cell therapy manufacturing processes?In this episode with Shin Kawamata, CEO of Cyto-Facto Inc., we dive into the transformative power of digitization in cell therapy manufacturing and explore strategies to enhance efficiency and reduce costs.Actionable Takeaways:Initiate Digital Transformation: Take the first step toward transforming your manufacturing processes by incorporating robust data business practices, ensuring a maturation of the cell therapy industry.Leverage AI and Metabolome Sensors: Discover actionable insights into harnessing the power of AI for navigating cell therapy...
2024-01-2518 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation21: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin Kawamata - Part 1Are the escalating costs and intricate technical hurdles of cell therapy development causing you stress?Tune into this insightful podcast episode featuring Shin Kawamata, CEO of Cyto-Facto Inc. in Kobe, Japan, who shares his expertise and innovative solutions to these pressing issues in the cell therapy industry.Discover how to streamline your manufacturing processes, reduce costs, and enhance product quality, transforming the way you approach cell therapy development.Key Takeaways:Revolutionize Cell Manufacturing: Shin outlines how Cyto-Facto is pioneering a new business model, merging public sector support with commercial viability. Learn how...
2024-01-2322 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation20: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 2Welcome to Part 2 of our conversation with Bernardo Estupiñán Gaisbauer, Principal at Drug Biologics Consulting.In this insightful episode, we dive into the complex world of taking a molecule from the lab to clinical trials. Our guest shares invaluable insights into outsourcing strategies for biotech companies.Key Learnings:Strategic Outsourcing: Discover when and why outsourcing is crucial for biotech companies, particularly in areas like analytical work and process development. Learn how it can be a game-changer for companies of all sizes.Critical Outsourcing Steps: Understand the pivotal role of analytics in confirming lab re...
2024-01-1817 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation19: How to Take Your Molecule From the Lab to Clinical Trials w/ Bernardo Estupiñán Gaisbauer - Part 1Are you ready to unlock the secrets of taking your molecule from the lab to clinical trials?Join us in an exclusive interview with Bernardo Estupiñán Gaisbauer, a seasoned expert and principal at Drug Biologics Consulting, as he reveals the crucial steps and strategies necessary for a successful journey in CMC development.Biotech scientists often underestimate the challenges of transitioning a molecule from the lab into large-scale production. Bernardo emphasizes the critical importance of addressing Developability and Manufacturability early on.Key Learnings:Consider Developability and Manufacturability: The success of your biotech as...
2024-01-1619 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation18: How Extracting Gold From Your Data Accelerates Process Development w/ Ioscani Jiménez del Val - Part 2In part 2 of this interview with Ioscani, Assistant Professor at the School of Chemical & Bioprocess Engineering, University College Dublin, we delve into the art and science of accelerating process development through the strategic extraction of valuable insights from data.Our guest, a seasoned expert in computational modeling, unfolds the intricate dance between quality by design principles and data-driven approaches.Key takeaways from this insightful conversation include:Optimizing with Confidence: Understand the input-output relationships qualitatively and quantitatively. Frame confidence spaces and align them with the design space for robust models.Strategic Experimentation
2024-01-1113 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation17: How Extracting Gold From Your Data Accelerates Process Development w/ Ioscani Jiménez del Val - Part 1Join us as we unravel the complexities of computational methods in bioprocessing, featuring cutting-edge research on glycosylation and process development.Ioscani Jiménez del Val, Assistant Professor at the School of Chemical & Bioprocess Engineering, University College Dublin, explores the intricacies of creating computational models, closing the loop, and optimizing with numerical methods.Discover the two broad flavors of modeling – kinetic and metabolic models – and how they contribute to understanding cellular processes in bioreactors.Key Learnings:Closed Loop Optimization: Learn how closing the computational loop enhances model robustness, generating experimental data to refine kinet...
2024-01-0919 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation16: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat Thalmann - Part 2In part 2, we explore the details of cost reduction in cultivated meat manufacturing, with a focus on two important factors: media and simplified bioreactors.Beat Thalmann, a passionate innovator and serial entrepreneur specializing in the development of animal-free cell culture systems, highlights the strategic importance of selecting the right cells and advocates for a streamlined process that incorporates plant-based structures. This approach offers a cost-effective entry point for supermarkets.Key Learnings:Discover the challenges of adapting adherent media for meat cells in suspension culture.Find out the most cost-effective approach that enables competitive pricing...
2023-12-2119 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation15: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat Thalmann - Part 1Is bacon without pigs the future? In this episode, join us as Beat Thalmann, a passionate innovator and serial entrepreneur specializing in the development of animal-free cell culture systems, unveils the exciting possibilities.Discover how he overcomes the challenges of production and envisions a future where cultivated steak competes on price. Beat Thalmann provides an insider's perspective on the complexities of cell lines and production processes, exploring the intersection of biopharmaceuticals and cultivated meat.Explore the innovative techniques companies are adopting, from rethinking bioreactors to recycling media, in their quest to bring affordable and sustainable...
2023-12-1918 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation14: Digital Transformation in Biomanufacturing: A Rapidly Moving Tech Frontier w/ Abhijeet Satwekar - Part 2Are you struggling to unlock the full potential of Process Analytical Technology (PAT) in biomanufacturing?Look no further!Join us for a game-changing conversation with Abhijeet Satwekar, an Innovation Manager at Merck Guidonia-Rome, Italy.Discover how PAT can revolutionize your decision-making, accelerate development timelines, and propel your biotech company to new heights.Key Learnings:Decoding PAT's Impact: Abhijeet provides unprecedented insights into how PAT technologies revolutionize decision-making in real-time, ensuring unparalleled control over manufacturing processes. Discover the race towards achieving real-time release and initiatives...
2023-12-1417 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation13: Digital Transformation in Biomanufacturing: A Rapidly Moving Tech Frontier w/ Abhijeet Satwekar - Part 1Wondering how you can leverage the immense potential of the rapidly evolving world of digital transformation in biomanufacturing?Join us as we explore the frontiers of technology and innovation with Abhijeet Satwekar, Innovation Manager at Merck Healthcare.Discover how cutting-edge digital technologies are revolutionizing bioprocesses, optimizing efficiency, and ensuring consistent product quality.Key Learnings:Process Optimization: Discover the transformative impact of digital technologies on optimizing processes from small-scale studies to large-scale manufacturing, ensuring robustness and consistent product quality.Digital Twin and Efficiency: Explore the realm of digital twins, simulations, and business intelligence...
2023-12-1217 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation12: From Lab to Patient: Steve Oh’s Guide to Mastering Cell Therapy Process Development - Part 2Welcome back to the second part of our exclusive interview 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.In this episode, Steve dives deep into the challenges of manufacturing different cell types, sharing insights gained from his groundbreaking research. From preventing spontaneous differentiation to optimizing multi-stage processes, Steve unveils the complexities of mastering cell therapy development.Key Takeaways:Controlled Differentiation: Learn how Steve tackled the challenge of directed differentiation in a dynamic environment...
2023-12-0717 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...
2023-12-0526 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation10: Revolutionizing Cell-Line Development: Unleashing the Power of Nanopens and Microenvironments w/ Tanner Nevill - Part 2Unlock the secrets of cell-line development with Tanner Nevill, the SVP of Applications at Bruker Cellular Analysis and one of the primary inventors and developers of the Beacon Optofluidic Platform.In this interview, Tanner delves into the transformative power of nanopens and microenvironments in cell-line development.Key Takeaways:Nanopens Redefining Norms: Tanner introduces the game-changing nanopens, disrupting traditional cell line development. Learn how these innovative tools are reshaping the landscape and ushering in a new era of efficiency.AI's Impact on In Silico Discovery: Explore the future of...
2023-11-3015 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation09: Revolutionizing Cell-Line Development: Unleashing the Power of Nanopens and Microenvironments w/ Tanner Nevill - Part 1In this episode, Tanner Nevill, the SVP of Applications at Bruker Cellular Analysis and one of the primary inventors and developers of the Beacon Optofluidic Platform, shares insights into revolutionizing cell-line development through nanopens and microenvironments.Key Takeaways:Challenging the Status Quo: Tanner challenges conventional thinking, highlighting the limitations of planar cell cultures and the shortcomings of traditional approaches in the field. His perspective sparks a conversation about the need for innovative thinking in bioprocess development.The Multidisciplinary Nature of Cell-Line Development: Tanner emphasizes the importance of multidisciplinary collaboration in the industry. He stresses that success...
2023-11-2814 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation08: Unveiling the Power of Microcarriers: Scaling Up Adherent Cell Cultures in Bioprocessing w/ Payar Radfar - Part 2In the second part of our insightful interview with Payar Radfar, CEO of Smart MCs, we delve into the practical steps of developing adherence cell cultures for bioprocessing scalability.Payar emphasizes the critical need for patience and a methodical approach, recounting how many clients rush into large-scale cultures prematurely. The key takeaways include:1. Start Small, Stay Patient: Begin with small cultures and test various microcarriers. Patience is crucial; rushing can lead to ambiguous results and hinder long-term success. 2. Role of Modeling: Payar discusses the potential of AI modeling in...
2023-11-2313 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation07: Unveiling the Power of Microcarriers: Scaling Up Adherent Cell Cultures in Bioprocessing w/ Payar Radfar - Part 1In this episode, we explore the world of adherent cell cultures with Payar Radfar, CEO of Smart MCs. Smart MCs specializes in customized biomaterials and microfluidic solutions. Payar shares his unique journey in the biotech industry, driven by his passion for improving people's health.Key Takeaways:1. Revolutionizing Bioprocessing: Payar discusses the challenges scientists face when transitioning from lab-scale to industrial-scale production. He emphasizes the importance of a multidisciplinary approach and envisions his company playing a crucial role in simplifying and enhancing bioprocessing technologies.2. Cost Challenges in Cellular Therapies: Payar addresses the high costs...
2023-11-2116 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation06: Hybrid Modeling: The Key to Smarter Bioprocessing w/ Michael Sokolov - Part 2In the second part of our conversation with Michael Sokolov, the co-founder and COO of DataHow, we dive into practical insights on leveraging hybrid modeling in bioprocessing.You will discover:1. Starting Small, Dreaming Big: Even in smaller companies, you can start with a minimal number of reactors and still leverage hybrid modeling effectively. Whether it's just a few shakers or a handful of bioreactors, you can begin the journey to process improvement.2. The Power of Digital Twins: Michael sheds light on the concept of digital twins, which involves creating...
2023-11-1619 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation05: Hybrid Modeling: The Key to Smarter Bioprocessing w/ Michael Sokolov - Part 1In this insightful conversation, we explore how to accelerate bioprocess development and enhance manufacturing using hybrid modeling. Our guest, Michael Sokolov, COO of DataHow (a spin-off company from ETH Zurich), shares valuable insights.Discover the three major takeaways that could transform the bioprocessing industry:1. Unlocking the Power of Hybrid Modeling: Michael Sokolov introduces the revolutionary concept of hybrid modeling, which combines mechanistic knowledge with machine learning to expedite bioprocess development.2. Accelerating Process Development: Learn how hybrid modeling can speed up your bioprocessing efforts, potentially allowing you to reduce the...
2023-11-1416 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...
2023-11-0913 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...
2023-11-0717 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.
2023-11-0716 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...
2023-11-0716 minSmart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture InnovationBiotech Simplified: Your Path to Bioprocess Mastery Unveiled (Trailer)Are you a busy biotech scientist, trying to navigate the complex world of bioprocessing while fueling your passion for science? Join us on the Smart Biotech Scientist Podcast, where we're about to unravel the secrets to bioprocess mastery.Hosted by a seasoned biotech leader and entrepreneur with over 15 years in the industry, this podcast is your compass through the maze of challenges. Picture yourself in the lab, deadlines looming, feeling like you're solving a puzzle with missing pieces. We've been there, too.In this podcast, we simplify the journey to bioprocess mastery, providing practical solutions...
2023-10-3102 min