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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

23:50

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

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

2026/05/19

What if the key to scalable, off-the-shelf cell therapy was hiding in tissue that surgeons discard every day? Yuta Lee, Founder and CEO of Accelerated Bio, has spent two decades building a cell therapy platform on exactly that insight. Human trophoblast stem cells, sourced from ectopic pregnancy tissue that is otherwise discarded, sit at a unique biological intersection: earlier than MSCs, free from the ethical barriers of embryonic stem cells, expandable to 85 population doublings, and natur...

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18:18

252: How to Use Media Supplements to Tailor...

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

2026/05/14

Are you still using one-factor-at-a-time experiments for biosimilar development, losing months, missing interactions, and risking costly dead-ends? In this episode, David Brühlmann, host of the Smart Biotech Scientist Podcast, reveals how traditional "one factor at a time" screening in biosimilar development can take over 12 months, while the parallel group design massively accelerates discovery by grouping up to five factors per experiment and applying a multivariate analysis pipeline. Topic...

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18:11

251: Why a Single Large DoE Fails Biosimilar Glycan...

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

2026/05/12

Are you stuck screening endless compounds in biosimilar development and still not hitting your quality targets? Efficient compound screening is one of the toughest bottlenecks in biopharma, with outdated methods slowing progress and risking critical quality attributes in monoclonal antibody development. David Brühlmann breaks down a practical, parallel framework for rapid compound screening that addresses interaction effects, masking, and data quality. Methods proven in challenging biosimilar...

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20:49

250: How T Cell Activation Redefines TIL and CAR-T...

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

2026/05/07

When every batch belongs to a single patient, a single centralized facility cannot serve the world. In Part 2, Chantale Bernatchez moves from process development into the broader consequences of that reality: the manufacturing model built around clinical proximity, the global alliance bringing TIL production to regions with no current access, and the next-generation engineered approaches redefining what these therapies can do. Chantale Bernatchez is Head of Process Development at CTMC, a join...

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29:11

249: How T Cell Activation Redefines TIL and CAR-T...

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

2026/05/05

The most underappreciated parameter in cell therapy process development is not your bioreactor, your media, or your activation protocol. It is the patient. Chantale Bernatchez has spent 20 years learning that lesson the hard way, watching the same manufacturing process succeed brilliantly with one donor and fail completely with the next. In this episode, she explains why starting material variability is the defining challenge of cell therapy manufacturing, and what it actually takes to build ...

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19:08

248: Nitrosamine Risk Assessment and CRO Selection:...

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

2026/04/30

Getting an NDA signed shouldn't take weeks. If your CRO needs more than 48 hours to start the paperwork, your project timeline is already moving in the wrong direction. Ron Najafi knows what rigorous analytical work actually looks like under pressure. As founder and CEO of Emery Pharma, he led the investigation that identified NDMA as a degradation product of ranitidine — findings the FDA formally validated and that reshaped how the industry approaches nitrosamine risk assessment. In Part 2, ...

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33:51

247: Nitrosamine Risk Assessment and CRO Selection:...

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

2026/04/28

When drug safety fails, patients and entire markets pay the price. Understanding your CMC isn't just compliance — it's the line between therapeutic promise and product recall. Ron Najafi has lived that reality firsthand. As founder of NovaBay Pharmaceuticals and Emery Pharma, he spent decades building companies at the intersection of analytical chemistry and drug development. His investigation into nitrosamine contamination in ranitidine — which led the FDA to formally validate Emery Pharma's...

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22:31

246: Why Your Shake Flask Culture Doesn't Scale: OTR,...

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

2026/04/23

Shear sensitivity is the silent challenge behind many advanced biomanufacturing modalities. Orbital-shaken bioreactors—often underestimated—may be a key enabler your CMC development is missing. Tibor Anderlei, CSO at Kühner Shaker, joined David Brühlmann on the Smart Biotech Scientist Podcast to unpack the hidden physics behind bioprocess reproducibility and next-generation shaking technology. He has seen firsthand how overlooking fundamental parameters can derail scale-up and delay developme...

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27:25

245: Why Your Shake Flask Culture Doesn't Scale: OTR,...

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

2026/04/21

Why do small-scale bioprocess experiments often fail to translate in scale-up despite “perfect” results on paper? Tibor Anderlei, Chief Scientific Officer and leader of customer support at Kühner Shaker, has spent three decades solving an issue that frustrates CMC leaders and biomanufacturing teams worldwide. He pioneered online monitoring in shake flasks, co-founded AC Biotec, and now helps organizations avoid costly trial-and-error with high-throughput screening and orbital shaken bioreacto...

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17:45

244: Prevent the Delays That Derail Biologics Tech...

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

2026/04/16

When a single mismanaged tech transfer threatens an entire development program, pressure on CMC leaders and bioprocess teams is intense. The truth? Tech transfers aren’t a black box. They’re complex, but solvable with the right mindset and playbook. In this episode, David Brühlmann explores the practical side of tech transfer and scale-up within the biotech industry. With more than 15 years of experience, he shares personal stories and industry-tested frameworks that help demystify the comple...

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14:47

243: Turn Tech Transfer from a Gamble into a Managed...

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

2026/04/14

What if the hidden cost of your bioprocess lies not in the technology, but in what you don’t document? Too often, biotech teams discover too late that their “proven” process is just an illusion, propped up by undocumented tricks and missing critical parameters. In this episode, David Brühlmann strips down the assumptions behind scale-up and tech transfer, exposing the silent risks that threaten CMC milestones and market launches alike. After 15 years guiding biotech projects from bench to cli...

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17:46

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

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

2026/04/09

What if the solution to cell therapy’s biggest cold-chain challenge comes from the biology of Arctic fish? This conversation features Steve Oh, a leader in advanced bioprocessing, whose career has placed him at the intersection of stem cell biology, process engineering, and clinical translation. Steve Oh joins David Brühlmann to share how XT Thrive®—a next-generation cryopreservation solution drawing from nature’s antifreeze proteins—lets cells survive, thrive, and simplify manufacturing from...

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20:26

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

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

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 Bioprocessing... ·

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 Bioprocessing... ·

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 Bioprocessing... ·

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 Bioprocessing... ·

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 Bioprocessing... ·

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 Bioprocessing... ·

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 Bioprocessing... ·

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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261 results

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