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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

20:26

241: DMSO in Cell Therapy: Why Viability Scores Hide...

Smart Biotech Scientist | The CMC and... ·

2026/04/07

Arctic fish survive in waters that would freeze most life solid. Not because they tolerate ice, but because their biology prevents crystals from forming in the first place. That same principle, translated into synthetic peptide chemistry, is now showing performance data that DMSO cannot match. Part 2 is where the science becomes practical. Steve Oh spent 22 years at Singapore's A*STAR accumulating 43 patents across stem cell bioprocessing, microcarrier technologies, and serum-free media. He n...

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18:47

240: Continuous Microbial Manufacturing: From Genetic...

Smart Biotech Scientist | The CMC and... ·

2026/04/02

Why do CDMOs keep building bigger stainless-steel facilities while their margins erode and Asian competitors undercut them on price? And what happens when big pharma decides to stop outsourcing altogether? The business model that sustained the industry for two decades is under pressure from every direction, and for many CDMOs, standing still is no longer a neutral position. In Part 2, Juergen Mairhofer, CEO of enGenes Biotech, shifts from the science to the stakes. Having spent over a decade ...

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27:21

239: Continuous Microbial Manufacturing: From Genetic...

Smart Biotech Scientist | The CMC and... ·

2026/03/31

What if continuous microbial manufacturing wasn't a pipe dream, but a reality quietly reshaping the foundations of bioprocessing? Meet Juergen Mairhofer, CEO of enGenes Biotech GmbH and a scientist with a rare dual fluency in molecular biology and bioprocess engineering. He's not just optimizing at the margins. He's devised a proprietary E. coli platform that radically stabilizes genetic stability and splits cell growth from protein production. Instead of stretching out fermentation for a few...

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13:59

238: High-Throughput Microbial Screening: Avoiding...

Smart Biotech Scientist | The CMC and... ·

2026/03/26

For many biotech innovators, high-throughput screening platforms promise faster discoveries and streamlined workflows. Yet beneath the surface, the reality is more demanding, requiring hands-on expertise, careful assay design, and a sharp understanding of microbial physiology to avoid mistakes that become expensive to fix downstream. David Brühlmann continues his conversation with Sebastian Blum, Market Development Manager in Europe at Beckman Coulter Life Sciences, who brings a practical, un...

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19:42

237: High-Throughput Microbial Screening: Avoiding...

Smart Biotech Scientist | The CMC and... ·

2026/03/24

Why do so many promising biotech ideas stall long before they reach the clinic or marketplace? For many, the answer lies hidden in the earliest phase of bioprocess development: upstream processing. It’s where strain selection, media optimization, and culture conditions set the stage for everything that follows. Yet, the smallest missteps here can snowball into expensive roadblocks downstream. This episode of Smart Biotech Scientist Podcast zeros in on why smart screening strategies and the ri...

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18:50

236: Plant-Based Biomanufacturing: How Molecular...

Smart Biotech Scientist | The CMC and... ·

2026/03/19

For years, mammalian cells and microbial systems have dominated the biotech landscape, shaping the economics and access to life-saving biologics. Yet, in countries where capital and infrastructure are limited, those gold-standard systems bring hefty price tags and daunting complexity. The answer isn't bigger bioreactors; it's alternative biomanufacturing approaches, such as molecular farming. Imagine medicines grown like crops, ready for harvest in days, not months. Meet Waranyoo Phoolcharoen...

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26:35

235: Plant-Based Biomanufacturing: How Molecular...

Smart Biotech Scientist | The CMC and... ·

2026/03/17

Imagine producing life-saving antibodies or vaccines not in sprawling stainless steel facilities, but in sunlit greenhouses, inside living, breathing plants. Waranyoo Phoolcharoen, Co-Founder and CTO of Baiya Phytopharm and Professor at Chulalongkorn University in Bangkok, leads the charge in molecular farming in Thailand, pioneering a shift from traditional biomanufacturing toward using whole plants as responsive biofactories. With a unique background in both pharmaceutical sciences and plan...

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22:06

234: Why Most Bioprocess Automation Projects Fail...

Smart Biotech Scientist | The CMC and... ·

2026/03/12

Picture a new bioprocess automation project: ambitious, expensive, and packed with promise. But after months of development, your team discovers a flaw that could have been caught with a simple mockup and a few sticky notes on a whiteboard. This episode confronts the real cost of skipping discovery, premature automation, and the myth that faster engineering always means faster solutions. Anthony Catacchio, CEO of Product Insight, continues his conversation with David Brühlmann to untangle the...

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21:07

233: Why Most Bioprocess Automation Projects Fail...

Smart Biotech Scientist | The CMC and... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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... ·

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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209 results

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