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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

20:47

273: Engineering iPSC Neurons for Parkinson's: From...

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

2026/07/28

Transplant iPSC-derived neurons into a Parkinson's brain and 97% die before they can restore function. Of the 3% that survive, most face the same pathogenic environment that killed the original neurons. This is the compounded biology and CMC problem defining CNS cell therapy today. Bilal Fares, neuroscience entrepreneur and co-founder of AzureCell, is translating a University of Geneva discovery into a genetically engineered iPSC platform built to solve it: neurons that don't just replace wha...

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15:51

272: From Static Scaffolds to Dynamic Matrices:...

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

2026/07/23

How much of your research lives and dies on the bench? Not because the idea isn’t sound, but because building reproducible, scalable biomaterials remains an unsolved puzzle. Jan Hunik and Matt Baker from MosaMatrix discuss the practical challenges and lessons learned from spinning out a biomaterials company from academia. They explore the importance of quality standards in biotech startups, building a team with complementary skills, and the realities of developing reproducible 3D culture syst...

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20:08

271: From Static Scaffolds to Dynamic Matrices:...

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

2026/07/21

What if the real obstacle in 3D cell culture and tissue engineering isn't the cells, but the very ground they grow on? For years, cell culture has relied on flat plastic and passive scaffolds. But biology doesn't happen on a petri dish—cells live in three dimensions, surrounded by a dynamic environment that talks back, adapts, and shapes development in ways static gels simply cannot. That's the premise behind MosaMatrix, a novel hydrogel platform designed to transform how we grow cells, engin...

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16:54

270: How to Turn Mesenchymal Stem Cells into...

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

2026/07/16

In the biotech industry, advancing cell-based therapies is not just about innovation. It's about solving real gaps where conventional treatments fall short, especially against complex, aggressive tumors. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Jun Yung Woo, Co-Founder of AGEM Bio, who offers an in-depth look at the science and strategy behind engineered mesenchymal stem cells (MSCs), with a focus on why glioblastoma is the right proving ground for...

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25:20

269: How to Turn Mesenchymal Stem Cells into...

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

2026/07/14

What if the answer to solid tumor therapy isn’t about making immune cells smarter—but about rethinking what a therapeutic cell can do For years, mesenchymal stem cells (MSCs) have turned heads for their ability to home in on damaged tissue, yet their clinical utility has lagged behind the hype. What would it take to transform MSCs from passive healers into precision vehicles for next-generation cancer treatment? This week, David Brühlmann sits down with Jun Yung Woo, Co-Founder of AGEM Bio, w...

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20:46

268: Why Affordable Insulin Is a Money Problem, Not a...

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

2026/07/09

Why does life-saving insulin cost hundreds of dollars a month for patients, when manufacturing costs are just a fraction of that price? What if the nonprofit model could change everything for affordable access? In the pharmaceutical industry, affordability and access remain two of the biggest hurdles for patients, especially when the economics of essential medicines seem stacked against them. Eric Moyal, founder of Project Insulin, is rewriting the rules of biosimilar development. Coming from...

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18:32

267: Why Affordable Insulin Is a Money Problem, Not a...

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

2026/07/07

Insulin was first discovered over a century ago—yet in the United States, 1 in 5 insulin-dependent patients still ration their lifesaving supply. Why is a molecule so essential, and so well understood, still so out of reach for so many? Eric Moyal, founder of Project Insulin, decided to challenge not just the science, but the business model itself. With a background in nonprofit fundraising—not drug development—he’s building a biosimilar insulin glargine and promising to sell it directly to p...

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21:10

266: From Human Variability to Automated Precision:...

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

2026/07/02

The cell and gene therapy industry faces massive hurdles—cost, scalability, and the need for highly skilled operators have historically limited the reach of these transformative treatments. advanced therapy medicinal products manufacturing innovation is urgently needed to overcome these challenges and unlock broader global access. Farlan Veraitch, founder and Chief Scientific Officer at Ori Biotech, is leading the way in reimagining manufacturing platforms using automation, modularity, and di...

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22:26

265: From Human Variability to Automated Precision:...

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

2026/06/30

What if the simple act of opening an incubator could undermine the consistency of your cell therapy manufacturing process? Unlike traditional biologics, the moment cells leave their incubator, subtle shifts in temperature, CO₂, and pH can spiral into mission-critical variability, jeopardizing everything from product yield to therapeutic potency. This episode features Farlan Veraitch, founder and Chief Scientific Officer of Ori Biotech. Trained at UCL’s Department of Biochemical Engineering, F...

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15:09

264: Why AI and Automation Tools Won't Deliver Until...

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

2026/06/25

Digital transformation in biotech is no longer just about adopting new tools, it's about building a foundation where automation, data standardization, and AI integration actually lead to real value and long-term success. For today’s episode, David Brühlmann is joined by David Hardy, a leader at Thermo Fisher Scientific. With years spent guiding automation and digital lab transformation projects around the globe, David’s perspective is equal parts pragmatic and visionary. He’s watched automati...

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16:35

263: Why AI and Automation Tools Won't Deliver Until...

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

2026/06/23

Despite cutting-edge equipment and brilliant minds, biotech labs often find half their data trapped in difficult-to-access spreadsheets or isolated in silos, making true digital transformation a major, industry-wide hurdle. David Hardy, a leading market and innovation strategist at Thermo Fisher Scientific with 25 years of experience at the intersection of data, automation, and laboratory science, is helping organizations bridge the gap between data chaos and actionable insight. Topics discus...

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15:38

262: How to Stop Defaulting to CHO: An Evidence-Based...

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

2026/06/18

Host David Brühlmann returns for a focused solo episode to provide an honest, data-driven perspective on the evolving landscape of host selection for biologics manufacturing. Building on part one, David reviews five alternative expression platforms and offers a clear, practical framework for scientists navigating host cell decisions today. David Brühlmann moves past simplistic "replacement" narratives to instead examine where each technology, from plant farming to cell-free systems, fits in t...

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20:23

261: Why CHO Is Still Winning (and the 5 Platforms...

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

2026/06/16

In this solo episode, David Brühlmann explores the evolving landscape of biologic manufacturing platforms beyond CHO (Chinese hamster ovary) cells. Drawing from previous interviews with platform pioneers and rigorous data analysis, David examines where established and emerging hosts find their strengths—and their limits—in today’s biomanufacturing environment. Topics Discussed The historical dominance of CHO cells and what’s changed in the last decade (00:08)Three critical areas where alterna...

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21:40

260: Why Strong Science Isn't Enough to Get Funded:...

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

2026/06/11

Funding novel therapeutics isn’t just “harder than ever”—the rules have changed entirely. The wild rush of capital into early-stage biotech during 2020–2021 gave way to a drought, making investor priorities sharper and startup hurdles higher than most founders realize. Michael Rome, Managing Director at Foresite Capital, joined the Smart Biotech Scientist Podcast to dissect what’s really driving funding decisions today, and what early-stage founders must do to stand out. Key topics discussed:...

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25:12

259: Why Strong Science Isn't Enough to Get Funded:...

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

2026/06/09

Strong science alone won’t get your biotech startup funded—investors are sizing up much more than just your molecule. Michael Rome, who leads therapeutics investing at Foresite Capital, brings a rare dual lens as both scientist and investor. Having trained as a Caltech biochemist and incubated dozens of biotech companies, he’s seen first-hand how world-class discoveries become market-ready solutions—or get left behind. Topics discussed: Why strong science isn't always enough to secure funding...

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24:37

258: Why Regulatory Affairs Belongs in Drug Design:...

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

2026/06/04

What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushed, or under-resourced. This episode features Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefense initiatives with hundreds of millions in US government support. Milan’s focus lies in streaml...

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23:34

257: Why Regulatory Affairs Belongs in Drug Design:...

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

2026/06/02

The gap between a “drug” and a true “product” is where many therapies fail. Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actually reach patients. His experience spans everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams align scientific innovation with the operational and regulatory realities needed for successful comm...

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18:29

256: Is Bioprocess Education Keeping Up With New...

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

2026/05/28

The "data lake" that was supposed to unify bioprocessing intelligence has, in most companies, become something else entirely: a data swamp, where information goes in and insight rarely comes back out. For anyone trying to deploy AI in GMP manufacturing, that is not a technical problem. It is the problem. Steffen Kreye has seen it from both sides. As former upstream development lead at Bayer and now Professor of Industrial Biotechnology at Berliner Hochschule für Technik, he brings an unusuall...

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25:42

255: Is Bioprocess Education Keeping Up With New...

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

2026/05/26

When AI can draft a literature review in minutes, the question bioprocess educators can no longer avoid is this: what does a student actually need to learn? Steffen Kreye has a clear answer. As Professor of Industrial Biotechnology at Berliner Hochschule für Technik, he trains engineers who step into industry ready to run a bioreactor, not just describe one. His argument is direct: hands-on lab competence is the one thing AI cannot replicate, and it is exactly what underfunding is quietly ero...

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22:27

254: How to Source, Manufacture, and Scale the...

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

2026/05/21

Can aging be fundamentally slowed or even reversed—not by science fiction, but by harnessing the unassuming power of super-early stem cells? In Part 1, Yuta Lee, Founder and CEO of Accelerated Bio, walked through the biology, ethical sourcing, and manufacturing profile of human trophoblast stem cells. In Part 2, the conversation shifts to the larger ambition: using those cells not just to treat disease, but to slow, stop, or reverse biological aging itself. The evidence starts with a striking...

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261 results

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