Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
von David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist
- wöchentlichErscheinungsrhythmus
- 22 mintypische Länge
- vor 3 Tagenletzte Folge
Folgenzu den neuesten
270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 2
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
269: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 1
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,
268: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 2
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 industr
267: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 1
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? Eri
266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 2
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
265: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 1
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 temperature, CO₂, and pH can s
264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 2
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. For today’s episode
263: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 1
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 hurdle. David Hardy, a l
262: How to Stop Defaulting to CHO: An Evidence-Based Host Selection Framework for Biologics
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 alternative expression p
261: Why CHO Is Still Winning (and the 5 Platforms That Beat It in Specific Contexts)
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 data analysis, David ex
260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 2
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 startup hurdles highe
259: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 1
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 scientist and investor
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 overloo
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
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 m
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 Berli
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 sourci
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. Huma
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 t
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
250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez - Part 2
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 manufacturing model built a
249: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez - Part 1
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 hard way, watching t
248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 2
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 actually looks like unde
247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1
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. As founder of NovaB
246: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 2
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 Kühner Shaker, joined D
245: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 1
Why do small-scale bioprocess experiments often fail to translate in scale-up despite “perfect” results on paper? Tibor Anderlei, Chief Scientific Officer and leader of customer support at Kühner Shaker, has spent three decades solving an i
244: Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMC
When a single mismanaged tech transfer threatens an entire development program, pressure on CMC leaders and bioprocess teams is intense. The truth? Tech transfers aren’t a black box. They’re complex, but solvable with the right mindset and
243: Turn Tech Transfer from a Gamble into a Managed Process: The 6-Pillar Biologics Scale-Up Framework
What if the hidden cost of your bioprocess lies not in the technology, but in what you don’t document? Too often, biotech teams discover too late that their “proven” process is just an illusion, propped up by undocumented tricks and missing
242: DMSO in Cell Therapy: Why Viability Scores Hide the Real Toxicity with Steve Oh - Part 2
What if the solution to cell therapy’s biggest cold-chain challenge comes from the biology of Arctic fish? This conversation features Steve Oh, a leader in advanced bioprocessing, whose career has placed him at the intersection of stem cell
241: DMSO in Cell Therapy: Why Viability Scores Hide the Real Toxicity with Steve Oh - Part 1
Arctic fish survive in waters that would freeze most life solid. Not because they tolerate ice, but because their biology prevents crystals from forming in the first place. That same principle, translated into synthetic peptide chemistry, i
