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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

21:07

233: Why Most Bioprocess Automation Projects Fail...

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

2026/03/10

Many bioprocess automation projects fail, not because the technology is wrong, but because no one clearly defined the problem before buying the robot. In this episode, David Brühlmann sits down with Anthony Catacchio, CEO of Product Insight, to explore why rigorous system design and honest problem definition matter more than any individual technology, and how industrial robotics expertise translates directly into smarter lab automation. Highlights from the episode: Why biotech's "special case...

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18:16

232: From IND to BLA: The Biologics CMC Decisions...

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

2026/03/05

How solid is your CMC foundation—and what happens if it cracks under pressure? David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His “house building” approach demystifies CMC...

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19:39

231: From IND to BLA: The Biologics CMC Decisions...

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

2026/03/03

Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later. Henri Kornmann has spent two decades making those decisions the right way. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has crossed between CMC development, GMP manufacturing, and due diligence across som...

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19:00

230: Cyanobacteria Biomanufacturing: Achieving...

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

2026/02/26

What if the future of sustainable manufacturing required no sugar feedstocks, generated minimal waste, and operated carbon-neutral from day one? Ocean-derived cyanobacteria are making this possible—but the path from promising strain to profitable business is littered with synthetic biology casualties. This episode reveals the strategic decisions that separate winners from failures. In Part 2, Tim Corcoran, CEO and Co-Founder of Deep Blue Biotech, exposes the hard truths about commercializing ...

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25:11

229: Cyanobacteria Biomanufacturing: Achieving...

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

2026/02/24

The chemicals industry remains locked into carbon-intensive, fossil-based manufacturing. Even engineered microbes like yeast or E. coli depend on expensive sugar feedstocks while generating significant waste. What if a photosynthetic organism could eliminate those constraints entirely—while commanding premium pricing as "ocean-derived"? On the Smart Biotech Scientist Podcast, Tim Corcoran, CEO and Co-Founder of Deep Blue Biotech, reveals how a recently discovered fast-growing marine cyanobact...

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15:52

228: Media-Based Glycan Engineering for Biosimilars:...

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

2026/02/17

How early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity from initial process characterization. Deferring glycosylation characterization until after titer targets are met introduces risk: quality attribute gaps discovered late in development force process re-optimization, extended timelines, and potential cell line reselection. Media supplementation enables earlier intervention—tuning glycan distribut...

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16:34

227: Media-Based Glycan Engineering for Biosimilars:...

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

2026/02/10

When your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperature shifts that compromise titer, kifunensine supplementation that requires extensive regulatory justification, or 12-18 months to reclone and revalidate. Media supplementation offers an alternative pathway—tuning glycan profiles through formulation adjustments rather than cell line or process re-engineering. In this episode, David Brühlmann pres...

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16:00

226: Mastering Radiopharmaceutical Development:...

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

2026/02/05

Hard-to-treat cancers like pancreatic ductal adenocarcinoma (PDAC) have long defied conventional therapies. Radiopharmaceuticals, combining targeted therapy with diagnostic power, are creating new opportunities in precision oncology. Host David Brühlmann speaks with Bryan Miller of Crown Bioscience, who explains how Crown's strategic partnerships, rigorous quality standards, and adaptive study design are shaping radiopharmaceutical development—delivering speed, safety, and real clinical impac...

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17:55

225: Mastering Radiopharmaceutical Development:...

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

2026/02/03

Imagine treating cancer with the precision of a guided missile—delivering radioactive payloads directly to tumor cells. Radiopharmaceuticals are reshaping cancer diagnostics and therapy by pairing tumor-targeting molecules with radioisotopes for diagnosis or therapy. But what does it really take to develop these therapies, and why is interest from scientists, biotech companies, and pharma accelerating? In this episode, we're joined by Bryan Miller, Director of Scientific and Technical Operati...

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16:40

224: From Cultivated Meat to Chocolate: Rethinking...

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

2026/01/29

The cultivated meat industry has captured headlines and struggled with economics. Meanwhile, plant cell biomanufacturing is quietly solving the cost equation and approaching commercial launch. The question isn't whether cellular agriculture can work at scale. It's which applications will get there first, and what bioprocessing innovations will make it possible. In Part 2, we dive into the commercialization challenges that separate laboratory curiosity from market-ready products. Steven Lang t...

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27:50

223: From Cultivated Meat to Chocolate: Rethinking...

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

2026/01/27

What if the chocolate industry's reliance on equatorial farms—and the deforestation that comes with it—could be eliminated entirely? Plant cell bioreactors are doing that, producing real cacao without a single tree. But this isn't just about chocolate. It's about fundamentally rethinking how we manufacture food at scale, and the bioprocessing innovations emerging from this shift have implications far beyond the food industry. Steven Lang, Head of R&D at California Cultured, spent two deca...

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15:23

222: From 2D Cultures to Advanced 3D Cell Models for...

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

2026/01/22

What happens when we move beyond oversimplified cell cultures and truly embrace the complexity of human biology? In this episode of the Smart Biotech Scientist Podcast, we explore how advanced 3D cell models are reshaping preclinical research—recreating human tissue microenvironments to better understand tumors, immunotherapies, and gene and cell therapies. David’s guest is Catarina Brito, Principal Investigator at ITQB NOVA and Head of the Advanced Cell Models Laboratory at iBET and ITQB NOV...

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19:45

221: From 2D Cultures to Advanced 3D Cell Models for...

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

2026/01/20

What if the failure rate in clinical trials isn't about picking the wrong drug candidates—but about testing them in the wrong models? When you move cells from a 2D culture plate into a bioreactor, you're not simply scaling volume. You're fundamentally changing the biological context. Cell density shifts. Mass transfer dynamics evolve. Mechanical cues emerge. The cells sense these changes and respond—often in ways that derail strategies built on oversimplified assumptions. Most preclinical res...

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17:43

220: From 10,000 Structures to 1.8 Billion...

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

2026/01/15

The biotech industry stands on the verge of a radical transformation thanks to artificial intelligence (AI) and machine learning (ML). But even the most sophisticated algorithms are only as smart as the data feeding them. David Brühlmann sits down with Troy Lionberger, Chief Business Officer at A-Alpha Bio, whose team has quietly shattered the data ceiling by measuring and curating more than 1.8 billion protein interactions. Troy Lionberger brings an insider’s perspective from the frontlines ...

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26:55

219: From 10,000 Structures to 1.8 Billion...

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

2026/01/13

Antibody therapeutics have transformed modern medicine, but for many scientists, developing new candidates still feels like searching for a needle in a haystack—a slow, expensive, and unpredictable process. Structural biology and high-throughput data generation are now collapsing that haystack, offering unprecedented visibility into the molecular handshake that drives life: protein-protein interactions. In this episode, David Brühlmann sits down with Troy Lionberger, Chief Business Officer at...

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17:56

218: Silkworm Biomanufacturing: From Ancient Silk...

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

2026/01/08

For generations, silkworm pupae were discarded as waste from silk production. Now, KAICO is proving these organisms can function as highly efficient protein factories—producing complex vaccine antigens at yields and costs that challenge conventional bioreactor-based manufacturing. With a PCV2 oral vaccine already registered in Vietnam and a human norovirus vaccine preparing for Phase I clinical trials, the silkworm platform is moving from proof-of-concept to commercial reality. In Part 2, Mas...

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25:29

217: Silkworm Biomanufacturing: From Ancient Silk...

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

2026/01/06

For over 4,000 years, silkworms have connected civilizations through ancient trade routes. Now, KAICO Ltd., a Japanese biotech spin-off from Kyushu University, is transforming these creatures into living bioreactors capable of producing complex recombinant proteins and vaccine antigens—without the bioreactors, expensive media, or massive water consumption of conventional platforms. Masafumi Osawa, Business Development Lead at KAICO, brings an unconventional path to biotech. Trained in cultura...

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18:33

216: From Data Silos to Autonomous Biomanufacturing:...

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

2025/12/18

Biomanufacturing has always dealt with the challenge of turning vast, complex datasets and intricate production steps into life-changing therapies. But when batch records multiply and process deviations loom, how do biotech teams make sense of it all? In this episode, we move beyond theory to the nuts and bolts of how AI - when thoughtfully deployed - can turn bioprocessing chaos into actionable intelligence, paving the way for the factory of the future. Our guest, Ilya Burkov, Global Head of...

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21:34

215: From Data Silos to Autonomous Biomanufacturing:...

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

2025/12/16

Across biotech labs, researchers swim in oceans of process data: sensor streams, run records, engineering logs, and still, crucial decisions get stuck in spreadsheets or scribbled into fading notebooks. The challenge isn’t having enough information, it's knowing which actions actually move the needle in cell culture productivity, process stability, and faster timelines. This episode, David Brühlmann brings on Ilya Burkov, Global Head of Healthcare and Life Sciences Growth at Nebius AI. With a...

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14:49

214: From Developability to Formulation: How In...

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

2025/12/11

Computational methods can predict stability issues before the lab. But how do you actually implement these approaches in your formulation workflow? From excipient selection to long-term stability prediction, in silico tools are transforming how biotech teams develop robust formulations while reducing costly trial-and-error cycles. In Part 2, Giuseppe Licari, Principal Scientist in Computational Structural Biology at Merck KGaA, returns to share practical implementation strategies for integrat...

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261 results

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