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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

25:52

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

Smart Biotech Scientist | The CMC and... ·

2025/06/10

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...

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18:19

160: The Ultimate Guide to Accelerating Perfusion...

Smart Biotech Scientist | The CMC and... ·

2025/06/05

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 ...

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22:30

159: The Ultimate Guide to Accelerating Perfusion...

Smart Biotech Scientist | The CMC and... ·

2025/06/03

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...

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16:25

158: How to Detect Endotoxins Without Bleeding a...

Smart Biotech Scientist | The CMC and... ·

2025/05/29

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...

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22:38

157: How to Detect Endotoxins Without Bleeding a...

Smart Biotech Scientist | The CMC and... ·

2025/05/27

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 ...

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25:45

156: The Hidden Economics of Continuous Processing...

Smart Biotech Scientist | The CMC and... ·

2025/05/22

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...

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24:09

155: From Process Bottlenecks to Seamless Production:...

Smart Biotech Scientist | The CMC and... ·

2025/05/20

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...

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16:16

154: The Future of Bioprocessing: Industry 4.0,...

Smart Biotech Scientist | The CMC and... ·

2025/05/15

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...

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28:58

153: The Future of Bioprocessing: Industry 4.0,...

Smart Biotech Scientist | The CMC and... ·

2025/05/13

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 ...

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21:21

152: Is an Indian CDMO the Right Move for Your...

Smart Biotech Scientist | The CMC and... ·

2025/05/08

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 ...

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26:57

151: Is an Indian CDMO the Right Move for Your...

Smart Biotech Scientist | The CMC and... ·

2025/05/06

Send us a text Is an Indian CDMO the right move for your biologics pipeline? As Western biotech companies seek new strategic advantages, one question keeps surfacing: Is India truly becoming the next biotech manufacturing powerhouse? And what hidden capabilities are emerging that leading companies are racing to access? In this episode of the Smart Biotech Scientist Podcast, Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck, and Lonza, ...

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24:04

150: How to Leverage AI in Media Development Without...

Smart Biotech Scientist | The CMC and... ·

2025/05/01

Send us a text As biotech labs rush to adopt AI tools for cell culture media development, a critical question emerges: Are we creating a generation of scientists who know which buttons to push but not why they're pushing them? The automation trap that once transformed laboratory workflows now threatens to fundamentally alter how we understand the complex dynamics of culture media composition and performance. In this second part of our conversation with Tom Fletcher, R&D Director at Fujifi...

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18:27

149: How to Leverage AI in Media Development Without...

Smart Biotech Scientist | The CMC and... ·

2025/04/29

Send us a text From closely-guarded secrets to complex chemical interactions, cell culture media development has transformed from an afterthought to a critical competitive advantage in modern bioprocessing. But as AI and automation revolutionize the field, are we at risk of gaining speed while losing understanding? In this eye-opening episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Tom Fletcher, R&D Director at Fujifilm Irvine Scientific, who brings over 3...

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16:17

148: Lab-Grown Blood: How Stem Cells Transform...

Smart Biotech Scientist | The CMC and... ·

2025/04/24

Send us a text In the wake of the COVID-19 pandemic, the fragility of global blood supply systems became undeniably clear. Recognizing the urgent need for a more reliable and universal solution, Ari Gargir and his team at RedC Biotech are leading an ambitious effort to transform blood supply as we know it. Their mission? To develop lab-grown red blood cells that not only address chronic shortages but also overcome blood type compatibility - an innovation with the potential to reshape modern m...

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22:01

147: Lab-Grown Blood: How Stem Cells Transform...

Smart Biotech Scientist | The CMC and... ·

2025/04/22

Send us a text Blood is critical to global healthcare - vital for surgeries, trauma care, cancer treatment, and maternal health. Yet despite 120 million donations each year, a 100 million unit shortfall means nearly half the world’s needs go unmet. One person who understands this crisis firsthand is Ari Gargir, CEO & Founder of RedC Biotech. After surviving a paragliding accident thanks to a life-saving transfusion, he set out to tackle the global blood shortage. His team is now developin...

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18:09

146: Beyond ELISA: The 10-Minute Immunoassay Enabling...

Smart Biotech Scientist | The CMC and... ·

2025/04/17

Send us a text Stuck with outdated analytics while trying to develop cutting-edge therapies? Part 2 of our conversation with Bruno Oesch, CEO and founder of Elionova, reveals how biotech scientists can finally break free from incremental improvements and embrace the revolutionary immunoassay technology that's transforming bioprocessing workflows worldwide. For years, ELISA (Enzyme-Linked Immunosorbent Assay) has been vital in biotechnology, but its time-consuming protocols and complex washing...

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27:19

145: Beyond ELISA: The 10-Minute Immunoassay Enabling...

Smart Biotech Scientist | The CMC and... ·

2025/04/15

Send us a text Tired of waiting overnight for ELISA results? Serial entrepreneur Bruno Oesch reveals how his groundbreaking 10-minute immunoassay technology is eliminating the biggest bottleneck in bioprocessing workflows. From contributing to Nobel Prize-winning prion research to founding Prionics (the first commercial BSE test) and now revolutionizing immunoassays with Elionova, Bruno transforms high-end science into practical solutions that work for everyday labs. Here are three takeaways ...

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12:55

144: The Future of Biotech: Making Biotherapeutics...

Smart Biotech Scientist | The CMC and... ·

2025/04/10

Send us a text Imagine a future where every patient can access life-saving therapies and sustainable, high-quality food is within everyone’s reach. In this episode of the Smart Biotech Scientist, David Brühlmann explores how innovative biotech developments are making this vision a reality. Here’s a sneak peek of the breakthroughs covered: AI-Powered Picoliter Scale Testing: Discover how companies like Triple Bar Bio are pushing the boundaries of what's possible with their innovative microflui...

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15:32

143: Bioprocess Breakthroughs: How Smart...

Smart Biotech Scientist | The CMC and... ·

2025/04/08

Send us a text In the rapidly evolving world of biotechnology, innovation is not just happening at the molecular level. Industry leaders are making groundbreaking advancements in bioprocessing - a crucial component in making life-saving therapies more accessible and affordable. The journey to affordable therapies starts with the production process itself. In this podcast episode, David Brühlmann sheds light on innovations in bioprocess design that are setting new standards in efficiency and e...

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17:06

142: How Microalgae Cuts Antibody Costs by 70% and...

Smart Biotech Scientist | The CMC and... ·

2025/04/03

Send us a text What if we could revolutionize biotechnology by slashing antibody production costs by 70%? In a world where traditional mammalian cell cultures struggle with scalability and cost-effectiveness, an unexpected hero emerges from the depths of our oceans - microalgae. The use of microalgae in biotechnology is not just a novelty but a necessity, given the current demands for more efficient and cost-effective production methods. Muriel Bardor, co-founder, CEO and CSO of Alga Biologic...

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209 results

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