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Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders: Daily Summaries Delivered
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
Latest Episodes
The most recent episodes — sign up to get AI-powered summaries of each one.
- Yesterday24 min
258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2
What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushed, or under-resourced. This episode features Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefense initiatives with hundreds of millions in US government support. Milan’s focus lies in streaml...
- 3 days ago23 min
257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1
The gap between a “drug” and a true “product” is where many therapies fail. Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actually reach patients. His experience spans everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams align scientific innovation with the operational and regulatory realities needed for successful comm...
- 1 weeks ago18 min
256: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 2
The "data lake" that was supposed to unify bioprocessing intelligence has, in most companies, become something else entirely: a data swamp, where information goes in and insight rarely comes back out. For anyone trying to deploy AI in GMP manufacturing, that is not a technical problem. It is the problem. Steffen Kreye has seen it from both sides. As former upstream development lead at Bayer and now Professor of Industrial Biotechnology at Berliner Hochschule für Technik, he brings an unusuall...
- 1 weeks ago25 min
255: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 1
When AI can draft a literature review in minutes, the question bioprocess educators can no longer avoid is this: what does a student actually need to learn? Steffen Kreye has a clear answer. As Professor of Industrial Biotechnology at Berliner Hochschule für Technik and former upstream development lead at Bayer, he trains engineers who step into industry ready to run a bioreactor, not just describe one. His argument is direct: hands-on lab competence is the one thing AI cannot replicate, and ...
- 2 weeks ago22 min
254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee - Part 2
Can aging be fundamentally slowed or even reversed—not by science fiction, but by harnessing the unassuming power of super-early stem cells? In Part 1, Yuta Lee, Founder and CEO of Accelerated Bio, walked through the biology, ethical sourcing, and manufacturing profile of human trophoblast stem cells. In Part 2, the conversation shifts to the larger ambition: using those cells not just to treat disease, but to slow, stop, or reverse biological aging itself. The evidence starts with a striking...
- 2 weeks ago23 min
253: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee - Part 1
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...
- 3 weeks ago18 min
252: How to Use Media Supplements to Tailor Biosimilar Glycan Quality to Your Reference Product in Two Rounds
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...
- 3 weeks ago18 min
251: Why a Single Large DoE Fails Biosimilar Glycan Optimization — And the Parallel Screening Method That Actually Works
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...
About Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
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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