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 partnership
- You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness
- You 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 scrutiny
- You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources
What 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.com
Email us: hello@bruehlmann-consulting.com
Episodes
267 episodes
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 inno...
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 spira...
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 episo...
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...
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 platf...
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 examin...
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 higher th...
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 invest...
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,...
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 tha...
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 manuf...
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 Ber...
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 sour...
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. Hu...
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...
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 cri...
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 aroun...
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 the s...
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 un...
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 Nov...
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...
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...
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 play...
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 missi...
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 ce...