Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist

183 episodes

13 hours ago

What if the secret to making continuous bioprocessing practical, sustainable, and far simpler has been shaking - literally - just beneath our feet? For years, the industry has grappled with the complexities of continuous manufacturing, with technologies like ATF (alternating tangential flow) steadily dominating the perfusion landscape. But what if there's a game-changer right around the corner - a technology that vibrates membranes, not workflows, promising both higher performance and a green...

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What if the secret to making continuous bioprocessing practical, sustainable, and far simpler has been shaking - literally - just beneath our feet? For years, the industry has grappled with the complexities of continuous manufacturing, with technologies like ATF (alternating tangential flow) steadily dominating the perfusion landscape. But what if there's a game-changer right around the corner - a technology that vibrates membranes, not workflows, promising both higher performance and a green...

Show more...

Episodes (20/183)

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

171: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 1

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...

1 day ago

20 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

170: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 2

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...

6 days ago

22 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

169: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 1

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 ...

1 week ago

25 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 2

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...

1 week ago

24 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

167: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 1

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...

2 weeks ago

13 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 2

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 ...

2 weeks ago

17 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

165: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 1

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...

3 weeks ago

18 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 2

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...

3 weeks ago

19 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

163: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 1

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...

4 weeks ago

23 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 2

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...

1 month ago

15 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

161: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 1

If you’ve ever worked in a cell therapy lab or handled biologics, you’ve probably experienced the pitfalls of cryopreservation. We’ve all mourned the loss of precious samples after a freeze-thaw cycle gone wrong or watched viability figures plummet, wondering where it all went awry. In this episode of The Smart Biotech Scientist Podcast, Jeffrey Allen, Chairman and CEO of Evia Bio, shares how nature-inspired solutions are changing the cell preservation game. With a background spanning finance...

1 month ago

25 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

160: The Ultimate Guide to Accelerating Perfusion Process Development Using 96-Deep-Well Plates with Tom Valentin - Part 2

In this concluding episode of our deep dive into miniaturized perfusion systems, we tackle the most challenging aspect: implementing meaningful process analytical technology (PAT) at microscale while keeping costs realistic for high-throughput applications. Tom Valentin, group leader at CSEM for Automated Sample Handling, continues sharing CSEM's pioneering work in automated sample handling, revealing both the breakthrough opportunities and stubborn technical barriers that define the current ...

1 month ago

18 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

159: The Ultimate Guide to Accelerating Perfusion Process Development Using 96-Deep-Well Plates with Tom Valentin - Part 1

In bioprocess development, the ability to rapidly screen conditions and predict scale-up performance can mean the difference between a successful therapy launch and costly delays. Today's Smart Biotech Scientist episode features Tom Valentin from CSEM, who's pioneering revolutionary approaches to miniaturized perfusion systems that could transform how we develop biologics. Tom is a group leader at CSEM for Automated Sample Handling within the Life Sciences and Industry 4.0 business unit. As a...

1 month ago

22 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

158: How to Detect Endotoxins Without Bleeding a Single Horseshoe Crab with Anika Hoffmann - Part 2

In this concluding episode of our series on revolutionary endotoxin detection, we continue our conversation with Anika Hoffmann about transitioning from theory to practice in the quest for more reliable, sustainable testing methods. Anika is a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland. Having established why traditional LAL testing falls short in Part 1, we now explore how Anika's innovative KDO-based chemical analytical approach compares in real-wor...

1 month ago

16 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

157: How to Detect Endotoxins Without Bleeding a Single Horseshoe Crab with Anika Hoffmann - Part 1

Send us a text In biopharmaceutical manufacturing, endotoxins represent a silent but deadly threat – bacterial fragments capable of triggering severe immune responses at picogram levels, potentially leading to septic shock, organ failure, or even death in patients. In this eye-opening first episode, we speak with Anika Hoffmann, a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland, who's challenging the decades-old status quo of endotoxin testing. For nearly ...

1 month ago

22 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

156: The Hidden Economics of Continuous Processing That Most Biotech Companies Overlook

Send us a text The world of biologics manufacturing is undergoing a major transformation. Once dominated by traditional batch processes, the industry is now experiencing a marked shift toward continuous bioprocessing. But as companies contemplate this transition, two questions dominate strategic discussions: Will regulators accept continuous manufacturing? And, perhaps more pressingly, Does the business case justify making the switch? In this podcast episode of the Smart Biotech Scientist Pod...

1 month ago

25 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes Everything

Send us a text In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann dives into continuous bioprocessing - a major shift in biologics manufacturing that's turning traditional batch processes into streamlined, real-time operations. Imagine running your biologics process non-stop for 30 days, with smart monitoring and smaller, more efficient systems replacing massive reactors. It’s not just possible - it’s already happening across the industry, from Amgen’s 80% smaller fa...

1 month ago

24 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos - Part 2

Send us a text In this episode, Tiago Matos, Associate Principal Scientist/Associate Director in Bioprocess Drug Substance and Commercialization at Merck & Co., shares a critical insight: continuous manufacturing in biologics currently demands 2–3x more time and FTEs than traditional fed-batch approaches. This highlights both the complexity of the shift - and the urgency for smarter digital tools and cross-functional collaboration. With over a decade of experience and a strong track recor...

2 months ago

16 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

153: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos - Part 1

Send us a text As the biotechnology sector races toward digital transformation, the buzz around Industry 4.0 - with its promise of interconnected systems, automation, and data-driven operations - has never been louder. But is the industry truly ready? In this episode, we speak with Tiago Matos, Associate Principal Scientist/Associate Director in Bioprocess Drug Substance and Commercialization at Merck & Co., who brings a grounded, insider view. Despite the hype, he says most of biopharma ...

2 months ago

28 minutes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

152: Is an Indian CDMO the Right Move for Your Biologics Pipeline? with Abdelaziz Toumi - Part 2

Send us a text Is an Indian CDMO the right move for your biologics CMC development? Pulling back the curtain on what might be your next strategic manufacturing advantage, this episode reveals the hidden capabilities emerging from India that leading biotech companies are racing to access. As supply chain vulnerabilities continue to expose risks in traditional manufacturing models, could the solution lie halfway around the world? Joining us to reveal the inside story is Abdelaziz Toumi, CEO of ...

2 months ago

21 minutes