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
253 episodes
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...
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, is no...
240: Continuous Microbial Manufacturing: From Genetic Instability to 40-Day E. coli Processes with Juergen Mairhofer - Part 2
Why do CDMOs keep building bigger stainless-steel facilities while their margins erode and Asian competitors undercut them on price? And what happens when big pharma decides to stop outsourcing altogether? The business model that sustained the ...
239: Continuous Microbial Manufacturing: From Genetic Instability to 40-Day E. coli Processes with Juergen Mairhofer - Part 1
What if continuous microbial manufacturing wasn't a pipe dream, but a reality quietly reshaping the foundations of bioprocessing?Meet Juergen Mairhofer, CEO of enGenes Biotech GmbH and a scientist with a rare dual fluency in molecular bi...
238: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 2
For many biotech innovators, high-throughput screening platforms promise faster discoveries and streamlined workflows. Yet beneath the surface, the reality is more demanding, requiring hands-on expertise, careful assay design, and a sharp under...
237: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 1
Why do so many promising biotech ideas stall long before they reach the clinic or marketplace? For many, the answer lies hidden in the earliest phase of bioprocess development: upstream processing. It’s where strain selection, media optimizatio...
236: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen - Part 2
For years, mammalian cells and microbial systems have dominated the biotech landscape, shaping the economics and access to life-saving biologics. Yet, in countries where capital and infrastructure are limited, those gold-standard systems bring ...
235: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen - Part 1
Imagine producing life-saving antibodies or vaccines not in sprawling stainless steel facilities, but in sunlit greenhouses, inside living, breathing plants.Waranyoo Phoolcharoen, Co-Founder and CTO of Baiya Phytopharm and Professor at C...
234: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 2
Picture a new bioprocess automation project: ambitious, expensive, and packed with promise. But after months of development, your team discovers a flaw that could have been caught with a simple mockup and a few sticky notes on a whiteboard. Thi...
233: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 1
Many bioprocess automation projects fail, not because the technology is wrong, but because no one clearly defined the problem before buying the robot.In this episode, David Brühlmann sits down with Anthony Catacchio, CEO of Product Insig...
232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 2
How solid is your CMC foundation—and what happens if it cracks under pressure?David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading F...
231: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 1
Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later.Henri Kornmann has spent ...
230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 2
What if the future of sustainable manufacturing required no sugar feedstocks, generated minimal waste, and operated carbon-neutral from day one? Ocean-derived cyanobacteria are making this possible—but the path from promising strain to profitab...
229: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 1
The chemicals industry remains locked into carbon-intensive, fossil-based manufacturing. Even engineered microbes like yeast or E. coli depend on expensive sugar feedstocks while generating significant waste. What if a photosynthetic organism c...
228: Media-Based Glycan Engineering for Biosimilars: Your Rapid Implementation Guide
How early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity from initial process characterization. Deferring glycosylation characterization until after ti...