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PODCAST

Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders

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

The go-to CMC and bioprocessing podcast for process development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.Practical, execution-focused guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics.Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech

science life sciences

All Episodes

21:57

198: Mastering ADC Development: CDMO Strategies for...

Smart Biotech Scientist | The CMC and... ·

2025/10/16

What happens when the most complex molecules in biotech meet the organizational challenge of managing 300+ analytical scientists? The answer lies not just in the science, but in building systems that turn technical complexity into reliable delivery. In Part 2 of our deep dive with Amanda Hoertz, VP of Analytical and Formulation Sciences at KBI Biopharma, we shift focus from the molecular intricacies of ADCs to the operational mastery required to scale analytical development across multiple si...

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25:58

197: Mastering ADC Development: CDMO Strategies for...

Smart Biotech Scientist | The CMC and... ·

2025/10/14

What if the key to unlocking ADC manufacturing success lies in abandoning the platform mindset entirely? Antibody-drug conjugates represent biotech's most promising weapon against cancer: precision-targeted therapeutics that deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. But beneath the clinical promise lies a manufacturing reality that's rewriting the rules of bioprocess development, demanding analytical strategies that most CDMOs simply aren't equipped to h...

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25:04

196: Monolithic Chromatography Innovations: Solving...

Smart Biotech Scientist | The CMC and... ·

2025/10/09

What if solving tomorrow’s bioprocessing challenges meant questioning the very physics of chromatography and reimagining downstream processing from the ground up? For years, large biomolecules like viral vectors and exosomes have squeezed through the limitations of traditional chromatography, leaving scientists to wrestle with capacity trade-offs and slow mass transfer. But what if a fundamental shift could unlock breakthroughs for gene therapies, vaccines, and advanced biologics? In this tho...

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20:48

195: Monolithic Chromatography Innovations: Solving...

Smart Biotech Scientist | The CMC and... ·

2025/10/07

In this episode, host David Brühlmann is joined by Alois Jungbauer, Professor Emeritus at BOKU University, Vienna, and Scientific Advisor at BioChromatographix International. With over 40 years in bioprocess engineering and more than 400 published papers, Jungbauer offers a unique perspective on how downstream processing and purification technologies have evolved and where they’re headed next. Alois shares his unconventional journey into the world of biotech, starting from humble beginnings o...

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19:18

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

Smart Biotech Scientist | The CMC and... ·

2025/10/02

What if the future of affordable, life-changing cell and gene therapies comes down to one critical yet often overlooked factor: manufacturing efficiency? In advanced therapy medicinal products (ATMPs), groundbreaking science abounds, but the path to the clinic is still strewn with bottlenecks, especially when it comes to cost, complexity, and safety. While the promise is enormous, most therapies remain out of reach for many patients due to high cost of goods and logistical hurdles. What can a...

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29:11

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

Smart Biotech Scientist | The CMC and... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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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206 results

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