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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

25:18

181: Innovating Continuous Bioprocessing with...

Smart Biotech Scientist | The CMC and... ·

2025/08/19

What if one of biotech’s biggest production breakthroughs was hiding in plain sight? Not in a new gene or a wonder drug, but in the way we process and purify biologics. Perfusion technology, once dismissed as a pipedream in top biopharma boardrooms, is now quietly powering some of the industry’s most efficient and productive manufacturing platforms. Yet, transforming perfusion from controversial buzzword to gold standard required timing, vision, and a willingness to break from tradition. In t...

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26:25

180: How Mesenchymal Stromal Cells Are Transforming...

Smart Biotech Scientist | The CMC and... ·

2025/08/14

The promise of advanced cell therapies is undeniable, but as demand skyrockets, the challenges of taking a living drug from bench to bedside have never been greater. Each batch brings variability, each jurisdiction adds regulatory hurdles, and every strategic decision can determine whether a lifesaving therapy reaches patients or fizzles out behind clinical barriers. Lindsay Davies is a leading figure in the cell and gene therapy field, serving as Vice President-Elect for Europe at the Intern...

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23:06

179: How Mesenchymal Stromal Cells Are Transforming...

Smart Biotech Scientist | The CMC and... ·

2025/08/12

The key to conquering autoimmune diseases and type 1 diabetes may lie not in replacing lost cells, but in retraining the immune system using cells already within the body. Biotech is increasingly exploring stem cell therapies, but a quieter revolution is brewing: stromal cell therapy. These master “coordinators” aren’t about rebuilding tissues molecule by molecule - instead, they orchestrate an anti-inflammatory response, offering new hope for conditions once considered incurable. In this epi...

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20:38

178: Rethinking Cultivated Meat Production: Scale and...

Smart Biotech Scientist | The CMC and... ·

2025/08/07

The promise of cultured food is undeniable: delicious, sustainable meat and fish grown without the need for traditional farming. But the journey from lab bench to supermarket shelf is filled with complex regulatory, technological, and consumer acceptance challenges. The big question: how do we transform small-scale breakthroughs into global food production realities? In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann sits down with Richard Alldread, CTO of The Cultur...

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22:14

177: Rethinking Cultivated Meat Production: Scale and...

Smart Biotech Scientist | The CMC and... ·

2025/08/05

What if the secrets to feeding the planet - and democratizing access to future protein - were hiding in the core toolkit of biopharma? The worlds of biopharmaceuticals and cultured food may seem galaxies apart, but at their heart, both rely on remarkably similar technology: media, bioreactors, and cell processing. Yet, as demand grows for sustainable, affordable protein for the masses, innovators are confronting a challenge bigger than scale. This week, host David Brühlmann welcomes Richard A...

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14:29

176: How Virtual Reality Training Solves Europe's...

Smart Biotech Scientist | The CMC and... ·

2025/07/31

What if the missing link to resilient European bioproduction is not just another breakthrough technology, but the ability to continuously learn, adapt, and collaborate? In a rapidly shifting biotech landscape, innovation isn’t only driven by technical prowess. Behind every robust production process and every cutting-edge therapy, there’s a team empowered with both technical expertise and the soft skills necessary to thrive. In this episode, host David Brühlmann explores the human side of biop...

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19:40

175: How Virtual Reality Training Solves Europe's...

Smart Biotech Scientist | The CMC and... ·

2025/07/29

What if the road to bioproduction mastery started not in the lab, but with how you train your people? Traditional biotech education often ends at theory, leaving graduates unprepared for the fast-paced world of manufacturing. But what if the key to faster, safer, and more scalable bioprocessing is digital immersion, letting scientists train in a virtual facility before they ever enter a real one? This week, David Brühlmann welcomes Sandrine Lemoine, CEO of Immerscio.bio, to the Smart Biotech ...

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18:49

174: Mastering Hybrid Model Digital Twins: From Lab...

Smart Biotech Scientist | The CMC and... ·

2025/07/24

How do you transform hybrid model digital twins from promising lab concepts into commercial bioprocessing game-changers that actually deliver ROI? As biotech companies race to implement Industry 4.0 technologies, the critical challenge isn't just developing sophisticated hybrid models - it's deploying them strategically to create user-friendly, cost-effective solutions that genuinely accelerate your path to commercial bioprocessing success. In Part 2 of this essential conversation, David Brüh...

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21:04

173: Mastering Hybrid Model Digital Twins: From Lab...

Smart Biotech Scientist | The CMC and... ·

2025/07/22

Are you struggling to bridge the gap between lab-scale models and commercial bioprocessing reality? For many biotech innovators, the promise of digital twins meets harsh industrial constraints - where hybrid models that excel in controlled lab environments must prove themselves in the complexity of large-scale manufacturing. This week on the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Krist Gernaey, Professor of Industrial Fermentation Technology at the Technical University...

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19:43

172: Reimagining Chromatography for Advanced...

Smart Biotech Scientist | The CMC and... ·

2025/07/17

Downstream processing remains one of the most complex and critical steps in biomanufacturing, especially as new therapeutic modalities like cell and gene therapies push current technologies to their limits. The industry faces ongoing pressure to innovate, reduce costs, and improve efficiency, while still ensuring robust and reliable results. In this practical, energetic episode, host David Brühlmann welcomes Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (...

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20:35

171: Reimagining Chromatography for Advanced...

Smart Biotech Scientist | The CMC and... ·

2025/07/15

For decades, chromatographic purification has made use of bead-based diffusion - a reliable but limiting approach, especially as new modalities like gene therapies, mRNA, and viral vectors push the boundaries of what’s possible. But what if the future of downstream processing lies not in incremental improvement, but in a dramatic reimagining - from slow diffusion to rapid convection? In this episode, David Brühlmann meets Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix I...

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22:40

170: Why Your DNA Is a Terrible Disease Predictor...

Smart Biotech Scientist | The CMC and... ·

2025/07/10

For years, disease diagnosis and treatment have focused on a few biomarkers, overlooking thousands of vital biological signals. Despite biotech advances, most therapies are still based on limited data, missing countless breakthroughs. Multiomics changes that. By analyzing tens of thousands of proteins, metabolites, and lipids, it reveals hidden insights, paving the way for smarter, faster, and more effective medical discoveries. In this must-listen episode, David Brühlmann welcomes Mo Jain, f...

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25:33

169: Why Your DNA Is a Terrible Disease Predictor...

Smart Biotech Scientist | The CMC and... ·

2025/07/08

What if the secret to truly personalized precision medicine lies not in your genetic code, but in your zip code? For years, biotech has focused on genomics to explain disease and drug response, but DNA only accounts for a fraction of the story. The real breakthrough? Multi-omics: the large-scale analysis of proteins, metabolites, and lipids, powered by advanced mass spectrometry and AI, offering a fuller picture of human health. In this episode, David Brühlmann meets Mo Jain, founder and CSO ...

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24:51

168: How Generative AI Is Revolutionizing Biotech...

Smart Biotech Scientist | The CMC and... ·

2025/07/03

The promise of generative AI in pharma and biotech is huge, but it's also fraught with complexity, especially when it comes to integrating these systems into highly regulated environments. From monitoring evolving guidelines to balancing operational efficiency and data integrity, the journey from hype to real-world impact is filled with both opportunity and skepticism. In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck Healthcare’s Global Analytical...

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13:30

167: How Generative AI Is Revolutionizing Biotech...

Smart Biotech Scientist | The CMC and... ·

2025/07/01

Ever feel like you’re drowning in an ocean of constantly shifting regulatory guidelines? The world of biotech is a whirlwind of evolving standards, making compliance not just a headache, but sometimes the stumbling block between life-changing therapies and the patients who need them. But what if artificial intelligence could turn regulatory chaos into your biggest competitive advantage? In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck KGaA’s Globa...

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17:02

166: Why Your Funding Pitches Fail Despite Brilliant...

Smart Biotech Scientist | The CMC and... ·

2025/06/26

Have you ever presented a major scientific breakthrough, only to be met with blank stares and distracted executives? You're not alone. In this episode, David Brühlmann shares how he went from drowning in data to winning an innovation contest, not through better tech, but through the power of scientific storytelling. Many scientists default to methods and data, but as David notes, “it’s like being fluent in a language nobody else in the room speaks.” Without a clear link to human impact, even ...

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18:44

165: Why Your Funding Pitches Fail Despite Brilliant...

Smart Biotech Scientist | The CMC and... ·

2025/06/24

Have you ever poured months of research into a brilliant innovation, only to watch executives’ eyes glaze over during your presentation? You’re not alone. In this episode, host David Brühlmann describes a familiar frustration: scientists are trained to perfect data, not to sell ideas. But in today’s fast-paced biotech landscape, even the most groundbreaking technology risks fading into obscurity if it isn’t communicated effectively. Here’s what you’ll learn in this episode: Why Good Science N...

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19:17

164: How Moss Enables Production of Unproducible...

Smart Biotech Scientist | The CMC and... ·

2025/06/19

From lab curiosity to commercial reality. Here's what happens when moss meets the brutal economics of bioprocessing. In Part 1, you've heard the science behind moss-based protein production. Now comes the real test: Can it survive the gauntlet of regulatory scrutiny, cost pressures, and manufacturing scale-up that crushes most biotech innovations? In Part 2 of this groundbreaking conversation, David Brühlmann and Andreas Schaaf, Managing Director and CSO of Eleva, dive into the nuts and bolts...

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23:48

163: How Moss Enables Production of Unproducible...

Smart Biotech Scientist | The CMC and... ·

2025/06/17

What if the future of "impossible" protein therapeutics is hiding in your backyard? For decades, CHO cells have ruled the biotech kingdom as the undisputed champions of complex protein production. But here's the uncomfortable truth: countless breakthrough therapies are gathering dust on laboratory shelves—not because the science failed, but because traditional hosts can’t produce them. Enter moss. Yes, moss. That humble green organism clinging to rocks and trees might just be the biotech indu...

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15:35

162: How to Achieve 85%+ Cell Recovery Without DMSO's...

Smart Biotech Scientist | The CMC and... ·

2025/06/12

The world of cell therapy is changing rapidly, with revolutionary advancements in cryopreservation and bioprocessing protocols leading the way. In a recent episode of the Smart Biotech Scientist Podcast, host David Brühlmann sat down with Jeffrey Allen, Chairman and CEO of Evia Bio, to dive deep into the “how” of implementing cutting-edge techniques in the lab and the strategic mindset needed to move therapies from concept to clinic successfully. Jeffrey Allen is a passionate leader with a di...

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209 results

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