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Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist Farming Today Farming Today BBC Radio 4 Das Universum Das Universum Florian Freistetter, Ruth Grützbauch, Evi Pech StarTalk Radio StarTalk Radio Neil deGrasse Tyson Bacteriófagos Bacteriófagos Carmela García Doval Pharma and BioTech Daily Pharma and BioTech Daily Pharma and BioTech News Digimasters Shorts Digimasters Shorts Adam Nagus, Carly Wilson Ogami Station Ogami Station RatedPower Engines of Our Ingenuity Engines of Our Ingenuity Houston Public Media Chronicles of Aetherius Chronicles of Aetherius Robert Bower Qiological Podcast Qiological Podcast Michael Max Il Risveglio del Sogno Podcast Il Risveglio del Sogno Podcast Michele Battuello WeedSmart Podcast WeedSmart Podcast WeedSmart The Incubator The Incubator Ben Courchia & Daphna Yasova Barbeau OYSTER-ology OYSTER-ology Kevin Cox Urban Radar Urban Radar Tom Goodfellow and Beth Perry Bigfoot Society Bigfoot Society Jeremiah Byron Transmission Transmission Ysabelle Swan Relatos 3roticos En Español ORIGINAL Relatos 3roticos En Español ORIGINAL Eric PBS Space Time PBS Space Time PBS Adventure Sports Podcast Adventure Sports Podcast Curt Linville Nature's Archive Nature's Archive Michael Hawk The Jordan Harbinger Show The Jordan Harbinger Show Jordan Harbinger The Constant: A History of Getting Things Wrong The Constant: A History of Getting Things Wrong Mark Chrisler BJGP Interviews BJGP Interviews The British Journal of General Practice Earthlings 2.0 Podcast Earthlings 2.0 Podcast Lisa Ann Pinkerton Human Factors Minute Human Factors Minute Human Factors Cast Three Do Who Three Do Who Mike Beagen, Eric Stevens, James Hadwen-Bennett Today's Creation Moment Today's Creation Moment Creation Moments Flooba Flooba A Sensory Sound Space for Neurodivergent Minds सद्गुरु हिन्दी सद्गुरु हिन्दी Sadhguru Hindi Space News and Weather Today – Auroras, Rocket Launches & Night Sky Viewing Space News and Weather Today – Auroras, Rocket Launches & Night Sky Viewing Caloroga Labs Space News and Weather New Books in Anthropology New Books in Anthropology New Books Network The Archaeology Podcast Network Feed The Archaeology Podcast Network Feed The Archaeology Podcast Network The Chemical Show: Where Leaders Talk Business The Chemical Show: Where Leaders Talk Business Victoria Meyer Modern Math Teacher- Teaching Strategies for High School and Middle School Math Teachers Modern Math Teacher- Teaching Strategies for High School and Middle School Math Teachers Kristen Moore- High School Algebra Teacher + AI Educator + PBL Coach Long Covid Doctor Long Covid Doctor Dr Tim Robinson
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

Science

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist

265: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 1

June 29, 2026 10:00pm 22 min

What if the simple act of opening an incubator could undermine the consistency of your cell therapy manufacturing process? Unlike traditional biologics, the moment cells leave their incubator, subtle shifts in temperatur...

264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 2

June 24, 2026 10:00pm 15 min

Digital transformation in biotech is no longer just about adopting new tools, it's about building a foundation where automation, data standardization, and AI integration actually lead to real value and long-term success....

263: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 1

June 22, 2026 10:00pm 16 min

Despite cutting-edge equipment and brilliant minds, biotech labs often find half their data trapped in difficult-to-access spreadsheets or isolated in silos, making true digital transformation a major, industry-wide hurd...

262: How to Stop Defaulting to CHO: An Evidence-Based Host Selection Framework for Biologics

June 17, 2026 10:00pm 15 min

Host David Brühlmann returns for a focused solo episode to provide an honest, data-driven perspective on the evolving landscape of host selection for biologics manufacturing. Building on part one, David reviews five alte...

261: Why CHO Is Still Winning (and the 5 Platforms That Beat It in Specific Contexts)

June 15, 2026 10:00pm 20 min

In this solo episode, David Brühlmann explores the evolving landscape of biologic manufacturing platforms beyond CHO (Chinese hamster ovary) cells. Drawing from previous interviews with platform pioneers and rigorous dat...

260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 2

June 10, 2026 11:00pm 21 min

Funding novel therapeutics isn’t just “harder than ever”—the rules have changed entirely. The wild rush of capital into early-stage biotech during 2020–2021 gave way to a drought, making investor priorities sharper and s...

259: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 1

June 08, 2026 10:00pm 25 min

Strong science alone won’t get your biotech startup funded—investors are sizing up much more than just your molecule.Michael Rome, who leads therapeutics investing at Foresite Capital, brings a rare dual lens as both sci...

258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2

June 03, 2026 10:00pm 24 min

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 ...

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

June 01, 2026 10:00pm 23 min

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, execut...

256: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 2

May 27, 2026 10:00pm 18 min

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 t...

255: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 1

May 25, 2026 10:00pm 25 min

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 Bio...

254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee - Part 2

May 20, 2026 10:00pm 22 min

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 biol...

253: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee - Part 1

May 18, 2026 10:00pm 23 min

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...

252: How to Use Media Supplements to Tailor Biosimilar Glycan Quality to Your Reference Product in Two Rounds

May 13, 2026 10:00pm 18 min

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 Pod...

251: Why a Single Large DoE Fails Biosimilar Glycan Optimization — And the Parallel Screening Method That Actually Works

May 11, 2026 10:00pm 18 min

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 ...

250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez - Part 2

May 06, 2026 10:00pm 20 min

When every batch belongs to a single patient, a single centralized facility cannot serve the world. In Part 2, Chantale Bernatchez moves from process development into the broader consequences of that reality: the manufac...

249: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez - Part 1

May 04, 2026 10:00pm 29 min

The most underappreciated parameter in cell therapy process development is not your bioreactor, your media, or your activation protocol. It is the patient. Chantale Bernatchez has spent 20 years learning that lesson the ...

248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 2

April 29, 2026 10:00pm 19 min

Getting an NDA signed shouldn't take weeks. If your CRO needs more than 48 hours to start the paperwork, your project timeline is already moving in the wrong direction.Ron Najafi knows what rigorous analytical work actua...

247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1

April 27, 2026 10:00pm 32 min

When drug safety fails, patients and entire markets pay the price. Understanding your CMC isn't just compliance — it's the line between therapeutic promise and product recall.Ron Najafi has lived that reality firsthand. ...

246: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 2

April 22, 2026 10:00pm 22 min

Shear sensitivity is the silent challenge behind many advanced biomanufacturing modalities. Orbital-shaken bioreactors—often underestimated—may be a key enabler your CMC development is missing.Tibor Anderlei, CSO at Kühn...

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