Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist

205 episodes

6 hours ago

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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All content for Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation is the property of David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.

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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Episodes (20/205)

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 2

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...

2 days ago

20 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

203: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 1

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...

4 days ago

28 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

202: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 2

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...

1 week ago

24 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

201: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 1

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...

1 week ago

24 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 2

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 ...

2 weeks ago

20 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

199: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 1

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...

2 weeks ago

19 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

198: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 2

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...

3 weeks ago

21 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

197: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 1

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...

3 weeks ago

25 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

196: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 2

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...

1 month ago

25 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

195: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 1

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...

1 month ago

20 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

194: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 2

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...

1 month ago

19 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

193: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 1

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...

1 month ago

29 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

192: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 2

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...

1 month ago

19 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

191: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 1

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...

1 month ago

21 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 2

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...

1 month ago

17 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

189: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 1

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...

1 month ago

14 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 2

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)....

1 month ago

22 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

187: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 1

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 ...

2 months ago

19 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

186: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus - Part 2

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...

2 months ago

15 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

185: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus - Part 1

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...

2 months ago

22 minutes