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by David Brühlmann - CMC Development Leader, Biotech C-level Advisor, 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 in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.This podcast is for you if:You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnershipYou are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readinessYou are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutinyYou are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resourcesWhat you will learn:CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.Next Steps:Visit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
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Transplant iPSC-derived neurons into a Parkinson's brain and 97% die before they can restore function. Of the 3% that survive, most face the same pathogenic environment that killed the original neurons. This is the compounded biology and CMC problem defining CNS cell therapy today. Bilal Fares, neuroscience entrepreneur and co-founder of AzureCell, is translating a University of Geneva discovery into a genetically engineered iPSC platform built to solve it: neurons that don't just replace wha...
How much of your research lives and dies on the bench? Not because the idea isn’t sound, but because building reproducible, scalable biomaterials remains an unsolved puzzle. Jan Hunik and Matt Baker from MosaMatrix discuss the practical challenges and lessons learned from spinning out a biomaterials company from academia. They explore the importance of quality standards in biotech startups, building a team with complementary skills, and the realities of developing reproducible 3D culture syst...
What if the real obstacle in 3D cell culture and tissue engineering isn't the cells, but the very ground they grow on? For years, cell culture has relied on flat plastic and passive scaffolds. But biology doesn't happen on a petri dish—cells live in three dimensions, surrounded by a dynamic environment that talks back, adapts, and shapes development in ways static gels simply cannot. That's the premise behind MosaMatrix, a novel hydrogel platform designed to transform how we grow cells, engin...
In the biotech industry, advancing cell-based therapies is not just about innovation. It's about solving real gaps where conventional treatments fall short, especially against complex, aggressive tumors. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Jun Yung Woo, Co-Founder of AGEM Bio, who offers an in-depth look at the science and strategy behind engineered mesenchymal stem cells (MSCs), with a focus on why glioblastoma is the right proving ground for...
What if the answer to solid tumor therapy isn’t about making immune cells smarter—but about rethinking what a therapeutic cell can do For years, mesenchymal stem cells (MSCs) have turned heads for their ability to home in on damaged tissue, yet their clinical utility has lagged behind the hype. What would it take to transform MSCs from passive healers into precision vehicles for next-generation cancer treatment? This week, David Brühlmann sits down with Jun Yung Woo, Co-Founder of AGEM Bio, w...
Why does life-saving insulin cost hundreds of dollars a month for patients, when manufacturing costs are just a fraction of that price? What if the nonprofit model could change everything for affordable access? In the pharmaceutical industry, affordability and access remain two of the biggest hurdles for patients, especially when the economics of essential medicines seem stacked against them. Eric Moyal, founder of Project Insulin, is rewriting the rules of biosimilar development. Coming from...
Insulin was first discovered over a century ago—yet in the United States, 1 in 5 insulin-dependent patients still ration their lifesaving supply. Why is a molecule so essential, and so well understood, still so out of reach for so many? Eric Moyal, founder of Project Insulin, decided to challenge not just the science, but the business model itself. With a background in nonprofit fundraising—not drug development—he’s building a biosimilar insulin glargine and promising to sell it directly to p...
The cell and gene therapy industry faces massive hurdles—cost, scalability, and the need for highly skilled operators have historically limited the reach of these transformative treatments. advanced therapy medicinal products manufacturing innovation is urgently needed to overcome these challenges and unlock broader global access. Farlan Veraitch, founder and Chief Scientific Officer at Ori Biotech, is leading the way in reimagining manufacturing platforms using automation, modularity, and di...
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 in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.This podcast is for you if:You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnershipYou are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readinessYou are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutinyYou are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resourcesWhat you will learn:CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.Next Steps:Visit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
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