Shows
Smart 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...2025-06-1723 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...2025-05-2225 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...2025-05-2024 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...2025-05-0626 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...2025-05-0124 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...2025-04-1527 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...2025-04-0125 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.2025-03-2525 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...2025-02-2526 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 min