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PODCAST

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist

The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD

science life sciences

All Episodes

29:11

193: Viral Vector CDMO Mastery: Singapore's Answer to...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/30

Viral vectors are the backbone of cutting-edge cell and gene therapies, delivering life-altering treatments to patients with genetic diseases. But making these biological delivery vehicles is a high-wire act: unpredictable, complex, and fraught with hurdles that traditional biologics manufacturers have never faced. While the world races toward next-generation therapies, the challenge of producing viral vectors at clinical and commercial scale threatens to leave patients waiting on the sidelin...

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19:43

192: Process Intensification Secrets: A Process...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/25

Is continuous manufacturing delivering the transformative results everyone promised, or are you being sold an expensive solution to the wrong problem? While industry headlines tout revolutionary productivity gains, the economic reality behind continuous bioprocessing tells a more nuanced story that every process engineer needs to understand before making capital investment decisions. In this episode, host David Brühlmann continues his conversation with Andreas Castan, Strategic Technology and...

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21:16

191: Process Intensification Secrets: A Process...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/23

What if process intensification could transform your bioprocessing economics without the complexity most engineers fear? Getting 3x productivity gains and 30-150% titer increases once seemed reserved for Big Pharma's endless R&D budgets, but a strategic approach to technology selection is making these results achievable for companies of any size. In this episode, David Brühlmann speaks with Andreas Castan, a bioprocess veteran with over 25 years of industry experience who provides leaders...

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18:47

190: Why Smart Biotech Founders Plan CMC First (While...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/18

Still think you can "figure out CMC later"? Your competitors just implemented a systematic framework that cuts their IND timeline in half while you're still debating whether CMC matters. The founders who file INDs predictably aren't smarter than you. They just stopped gambling with ad-hoc CMC approaches and started executing proven systems. While you're wrestling with technical details in crisis mode, they built systematic advantages that turn regulatory complexity into competitive weapons. I...

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14:20

189: Why Smart Biotech Founders Plan CMC First (While...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/16

Think you can crack the science first and worry about CMC when you "need it"? That's exactly how promising therapies die in regulatory limbo while patients keep waiting. Your breakthrough discovery means nothing if it's trapped in CMC chaos. While you're perfecting your molecular mechanism, competitors with inferior science but superior CMC strategy are racing past you to IND filing and ultimately, to patients. In this episode, I, David Brühlmann, your usual host, expose the dangerous delusio...

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22:56

188: From Biology Is Messy to Designable: The Smart...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/11

For too long, biotech innovators have viewed biological systems as inherently messy, unpredictable, and full of “black box” mysteries. But what if, armed with the latest digital tools, AI, and cross-disciplinary thinking, you could transform bioprocessing from a series of trial-and-error experiments to a streamlined, proactive design process? Carmen Jungo Rhême is Full Professor at the University of Applied Sciences in Fribourg (HEIA-FR) and Director of the Biofactory Competence Center (BCC)....

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19:35

187: From Biology Is Messy to Designable: The Smart...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/09

Almost every corner of modern medicine and sustainable food production today is facing a massive challenge: how do we outpace drug-resistant “superbugs” and create food for a growing population using fewer resources? The answer, it turns out, may come down to how well we understand and control the biomanufacturing processes underpinning these biomaterials and biomolecules. In this episode, David Brühlmann speaks with Carmen Jungo Rhême, Full Professor at the University of Applied Sciences in ...

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15:49

186: How Generative AI Accelerates Protein Design for...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/04

Imagine unlocking a world where designing custom proteins is not only feasible - but faster, smarter, and more powerful than ever before, thanks to artificial intelligence. As the promise of programmable biology takes center stage, AI-driven protein engineering is rapidly moving from theoretical dream to industry standard. In this episode, David Brühlmann sits down with Elise de Reus, co-founder of Cradle, whose ground-breaking platform has become a go-to for luminaries at pharma giants, as w...

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22:51

185: How Generative AI Accelerates Protein Design for...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/09/02

For decades, protein design has hinged on painstaking rounds of wet lab mutagenesis and trial-and-error, a process limited not by human ingenuity, but by time and complexity. Yet as the biotech field seeks faster, greener, and more effective solutions for therapeutics and industrial applications, the next leap might not come solely from the lab bench. In this episode, host David Brühlmann explores the frontiers of AI-driven protein engineering with Elise de Reus, co-founder of Cradle. Elise’s...

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17:37

184: From Lab to Market: Secrets to Commercializing...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/28

What’s the secret to turning a cutting-edge scientific breakthrough into a commercial biotech success? For every inspiring lab discovery, countless prototypes stall before ever reaching the market. The barriers? Securing the right beta testers, outmanoeuvring industry giants, and building teams who understand not just the science, but the user experience from bench to bedside. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann welcomes Chervee Ho, CEO & Co-Founder of ...

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24:27

183: From Lab to Market: Secrets to Commercializing...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/26

Every year, cutting-edge biomedical technologies are left stranded in the lab, not for lack of innovation, but because they miss the crucial leap from technical performance to genuine industry adoption. The gap between scientific brilliance and commercial success is deceptively simple: deeply understanding and building for your customer’s real-world pain points. In this episode, David Brühlmann welcomes Chervee Ho, CEO & Co-Founder of BioChromatographix International. With a background at...

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15:20

182: Innovating Continuous Bioprocessing with...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/21

What if the secret to making continuous bioprocessing practical, sustainable, and far simpler has been shaking - literally - just beneath our feet? For years, the industry has grappled with the complexities of continuous manufacturing, with technologies like ATF (alternating tangential flow) steadily dominating the perfusion landscape. But what if there's a game-changer right around the corner - a technology that vibrates membranes, not workflows, promising both higher performance and a green...

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25:18

181: Innovating Continuous Bioprocessing with...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/19

What if one of biotech’s biggest production breakthroughs was hiding in plain sight? Not in a new gene or a wonder drug, but in the way we process and purify biologics. Perfusion technology, once dismissed as a pipedream in top biopharma boardrooms, is now quietly powering some of the industry’s most efficient and productive manufacturing platforms. Yet, transforming perfusion from controversial buzzword to gold standard required timing, vision, and a willingness to break from tradition. In t...

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26:25

180: How Mesenchymal Stromal Cells Are Transforming...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/14

The promise of advanced cell therapies is undeniable, but as demand skyrockets, the challenges of taking a living drug from bench to bedside have never been greater. Each batch brings variability, each jurisdiction adds regulatory hurdles, and every strategic decision can determine whether a lifesaving therapy reaches patients or fizzles out behind clinical barriers. Lindsay Davies is a leading figure in the cell and gene therapy field, serving as Vice President-Elect for Europe at the Intern...

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23:06

179: How Mesenchymal Stromal Cells Are Transforming...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/12

The key to conquering autoimmune diseases and type 1 diabetes may lie not in replacing lost cells, but in retraining the immune system using cells already within the body. Biotech is increasingly exploring stem cell therapies, but a quieter revolution is brewing: stromal cell therapy. These master “coordinators” aren’t about rebuilding tissues molecule by molecule - instead, they orchestrate an anti-inflammatory response, offering new hope for conditions once considered incurable. In this epi...

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20:38

178: Rethinking Cultivated Meat Production: Scale and...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/07

The promise of cultured food is undeniable: delicious, sustainable meat and fish grown without the need for traditional farming. But the journey from lab bench to supermarket shelf is filled with complex regulatory, technological, and consumer acceptance challenges. The big question: how do we transform small-scale breakthroughs into global food production realities? In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann sits down with Richard Alldread, CTO of The Cultur...

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22:14

177: Rethinking Cultivated Meat Production: Scale and...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/08/05

What if the secrets to feeding the planet - and democratizing access to future protein - were hiding in the core toolkit of biopharma? The worlds of biopharmaceuticals and cultured food may seem galaxies apart, but at their heart, both rely on remarkably similar technology: media, bioreactors, and cell processing. Yet, as demand grows for sustainable, affordable protein for the masses, innovators are confronting a challenge bigger than scale. This week, host David Brühlmann welcomes Richard A...

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14:29

176: How Virtual Reality Training Solves Europe's...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/07/31

What if the missing link to resilient European bioproduction is not just another breakthrough technology, but the ability to continuously learn, adapt, and collaborate? In a rapidly shifting biotech landscape, innovation isn’t only driven by technical prowess. Behind every robust production process and every cutting-edge therapy, there’s a team empowered with both technical expertise and the soft skills necessary to thrive. In this episode, host David Brühlmann explores the human side of biop...

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19:40

175: How Virtual Reality Training Solves Europe's...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/07/29

What if the road to bioproduction mastery started not in the lab, but with how you train your people? Traditional biotech education often ends at theory, leaving graduates unprepared for the fast-paced world of manufacturing. But what if the key to faster, safer, and more scalable bioprocessing is digital immersion, letting scientists train in a virtual facility before they ever enter a real one? This week, David Brühlmann welcomes Sandrine Lemoine, CEO of Immerscio.bio, to the Smart Biotech ...

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18:49

174: Mastering Hybrid Model Digital Twins: From Lab...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2025/07/24

How do you transform hybrid model digital twins from promising lab concepts into commercial bioprocessing game-changers that actually deliver ROI? As biotech companies race to implement Industry 4.0 technologies, the critical challenge isn't just developing sophisticated hybrid models - it's deploying them strategically to create user-friendly, cost-effective solutions that genuinely accelerate your path to commercial bioprocessing success. In Part 2 of this essential conversation, David Brüh...

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261 results

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