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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

17:45

206: Process Economics Decoded: How to Model...

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

2025/11/13

Carbon neutrality goals are everywhere in biopharma. But how do you actually measure and reduce your true environmental impact when data gaps and baseline differences make comparisons so tough? In this episode, David Brühlmann talks with Niklas Jungnelius, Cytiva’s expert in process modeling and sustainability, who’s spent years uncovering what really drives emissions and how small process tweaks can deliver big results. Niklas goes beyond the numbers, challenging assumptions and showing how ...

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25:35

205: Process Economics Decoded: How to Model...

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

2025/11/11

Your Manufacturing Decisions Are Costing You More Than You Think Every bioreactor decision. Every scale-up choice. Every facility investment. They're all silently writing checks your process might not be able to cash. The difference between a profitable biologics program and one that bleeds capital? Process economic modeling, the analytical framework that reveals exactly where your money goes and why. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann talks with Niklas Ju...

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20:13

204: Mastering CRO Selection: Essential Questions for...

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

2025/11/06

Cell and gene therapies are transforming modern medicine, but their path to market is fast and complex. They often jump from small trials to global launch at record speed, putting pressure on analytics, supply chains, and partnerships. Success depends on making smart choices about what to build in-house and what to entrust to expert partners. Daniel Galbraith knows these challenges intimately. With decades of hands-on experience and as Chief Scientific Officer at Solvias, Daniel has witnessed...

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28:40

203: Mastering CRO Selection: Essential Questions for...

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

2025/11/04

Finding an analytical CRO that's truly invested in your success, not just processing samples, makes all the difference in CMC development. In this episode, host David Brühlmann talks with Daniel Galbraith, Chief Scientific Officer at Solvias, about the essential questions and mindset that lead to breakthrough CRO partnerships. With nearly three decades in analytical development, spanning monoclonal antibodies, biosimilars, and cell and gene therapies, Daniel reveals what separates CROs who be...

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24:00

202: Fighting Antimicrobial Resistance: How AI Cuts...

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

2025/10/30

What if the answer to battling antibiotic-resistant infections isn’t a new antibiotic, but harnessing viruses that have been quietly dominating bacterial populations? Bacteriophages, viruses that target and kill bacteria, have been saving lives for a century, but their true potential is only now being unlocked by modern machine learning. The race isn’t just about discovering effective phages; it’s about deploying the right therapy, personalized to the patient, before time runs out. On this ep...

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24:46

201: Fighting Antimicrobial Resistance: How AI Cuts...

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

2025/10/28

Antibiotic resistance isn’t just a looming problem. It’s a global crisis. Every year, more than one million people die directly from resistant infections, and another 5 million die indirectly. Routine infections are becoming life-threatening, and healthcare systems worldwide are under pressure. Despite decades of warnings, pharmaceutical solutions are falling behind, while “superbugs” continue to outpace new drug development. If trends continue, by 2050, antibiotic resistance could claim 10 m...

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20:32

200: Mastering Quality by Design: From Product...

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

2025/10/23

Your process works perfectly at two-liter bench scale. Then you hit fifty liters and titer drops 20%. By two hundred liters, aggregation appears and charge variants shift. Your management team asks: "How long to fix this?" The honest answer? Three to twelve month, because you're flying blind. In Part 2 of this Quality by Design Master Class, David Brühlmann reveals why scale-up chaos isn't inevitable. It's a solvable engineering problem. Drawing on experience leading bioprocess innovation at ...

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19:44

199: Mastering Quality by Design: From Product...

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

2025/10/21

Over 40% of biotherapeutic failures during clinical development stem from stability problems—and most trace back to protein aggregation that could have been prevented. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann exposes the hidden manufacturing crisis that derails promising biologics programs and delivers the systematic Quality by Design framework that elite biotech companies use to build quality into every process step. David brings two decades of bioprocess exper...

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21:57

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

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

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 Bioprocessing... ·

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 Bioprocessing... ·

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 Bioprocessing... ·

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 Bioprocessing... ·

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 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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214 results

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