PODCAST · science
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
by David Brühlmann - CMC Development Leader, Bioprocess Expert, 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 partnership You are a
Episodes
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287: Why the Cell Line Is the CMC Decision You Don't Get to Undo with Sigma Mostafa - Part 1
A breakthrough in drug discovery can be derailed in an instant if manufacturability is left as an afterthought. Too many biotech programs hit bottlenecks at scale-up because key decisions in cell line and process development get kicked down the road. On the Smart Biotech Scientist Podcast, David...
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286: Why Your Dormant Omics Data Is Worth More Than the Data You'll Generate Next with Nathan Lewis - Part 2
What does it take to crack the code of protein production and why do some proteins stubbornly refuse to cooperate, despite the best efforts of scientists and engineers? Biotech’s ambitions are often limited not by vision, but by the real-world bottlenecks of host cell lines and the…
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285: Why Your Dormant Omics Data Is Worth More Than the Data You'll Generate Next with Nathan Lewis - Part 1
Dormant omics data are a goldmine for CMC innovation waiting to be unlocked. But legacy structures, poor annotation, and spreadsheet chaos hold most biotech teams back from the real breakthroughs. Nathan Lewis, GRA Eminent Scholar at the Center for Molecular Medicine, Complex Carbohydrate…
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284: Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection with Kent Rapp - Part 2
“Does DNA barcoding actually work?” It's the first question Kent Rapp hears from prospective customers when he pitches Biolinco's DNA barcoding platform. By his own admission, the technology can sound too good to be true. In Part 2 of this conversation, Kent rejoins the Smart Biotech Scientist...
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283: Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection with Kent Rapp - Part 1
What if the bottleneck in cell line development isn’t how many clones you screen, but how you track them? Cloning workflows have long relied on brute force: screen more cells, automate harder, and hope that small-scale performance predicts manufacturability. But too often, the “perfect” clone in…
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282: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra Kumar - Part 2
Your active ingredient is the nucleic acid. So why does a proteolipid vehicle filing include viral clearance studies, stability data and full characterisation of a membrane protein that is not the drug? Because that protein sits on the particle surface, and a component nobody has filed before is...
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281: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra Kumar - Part 1
Gene therapy only works if the cargo reaches the right cells intact. Adeno-associated viruses (AAV) and lipid nanoparticles have carried the field this far, but both share a constraint: the particle is taken up into an endosome, and the payload has to escape that compartment before it is…
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280: Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines with Christopher Locher - Part 2
For decades, drug development has been saddled with costly manufacturing, stringent biosafety requirements, and the limits of conventional carriers. But a new approach—born from cell-derived nanovesicles—could democratize access to advanced therapies and open entirely new doors for oral, topical,...
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279: Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines with Christopher Locher - Part 1
What if the best way to unlock durable, broad-spectrum immunity is to rethink the very vessels delivering our vaccines? While much of the industry focuses on refining existing delivery systems, Christopher Locher is charting a new course—one inspired by nature’s own couriers. Imagine a future…
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278: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 2
How do you take a model that works in process development and get it accepted for use in GMP manufacturing? That question stalls most bioprocess modeling projects before they start. Ignasi Bofarull-Manzano, Senior Data Scientist and CMC Consultant at Körber Pharma, pushes back on the premise: the...
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277: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 1
Most bioprocess teams believe a digital twin demands vast datasets and sophisticated models. Ignasi Bofarull-Manzano argues both assumptions are wrong, and that the data already sitting in your Excel files, historians and ELNs is probably enough to start. Ignasi Bofarull-Manzano, Senior Data...
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276: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 2
How do you turn a lab-born regenerative medical device into a solution that surgeons actually want to use and investors want to back? The path from academic innovation to clinical adoption is full of practical hurdles and strategic pivots, where compelling science alone isn’t enough. David...
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275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1
Imagine a wound too large for the body to close on its own. That's the problem Eva-Maria Balet set out to solve, not with living cells, but with a structural bridge that lets the body's own healing mechanisms do the rest. In this episode, David Brühlmann welcomes Eva-Maria Balet, Co-Founder & CEO...
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274: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 2
Building a cell therapy company is hard. Building a genetically engineered iPSC therapy for the brain, on a preclinical budget, is one of the hardest translational problems in biotech. Every experiment has to move the program closer to an IND, or it's motion without progress. That's the operating...
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273: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 1
Transplant iPSC-derived neurons into a Parkinson's brain and 97% die before they can restore function. Of the 3% that survive, most face the same pathogenic environment that killed the original neurons. This is the compounded biology and CMC problem defining CNS cell therapy today. Bilal Fares,...
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272: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 2
How much of your research lives and dies on the bench? Not because the idea isn’t sound, but because building reproducible, scalable biomaterials remains an unsolved puzzle. Jan Hunik and Matt Baker from MosaMatrix discuss the practical challenges and lessons learned from spinning out a...
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271: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 1
What if the real obstacle in 3D cell culture and tissue engineering isn't the cells, but the very ground they grow on? For years, cell culture has relied on flat plastic and passive scaffolds. But biology doesn't happen on a petri dish—cells live in three dimensions, surrounded by a dynamic...
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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 Scientist Podcast, host David Brühlmann welcomes Jun…
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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, yet their clinical utility has lagged behind the hype....
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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 industry, affordability and access remain two of the biggest...
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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? Eric Moyal, founder of Project Insulin, decided to challenge...
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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 innovation is urgently needed to overcome these…
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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 spiral into mission-critical variability, jeopardizing...
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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, David Brühlmann is joined by David Hardy, a leader at...
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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 leading market and innovation strategist at Thermo Fisher...
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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 platforms and offers a clear, practical framework for...
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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 examines where established and emerging hosts find their...
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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 than most founders realize. Michael Rome, Managing...
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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. Having trained as a Caltech biochemist and incubated...
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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...
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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...
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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...
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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, he trains engineers who step...
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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...
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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...
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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...
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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...
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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 around clinical proximity, the global alliance bringing…
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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 same manufacturing process succeed brilliantly with…
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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 under pressure. As founder and CEO of Emery Pharma, he led…
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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 NovaBay Pharmaceuticals and Emery Pharma, he spent decades...
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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 David Brühlmann on the Smart Biotech Scientist Podcast to...
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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 issue that frustrates CMC leaders and biomanufacturing…
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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 playbook. In this episode, David Brühlmann explores the...
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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 critical parameters. In this episode, David Brühlmann...
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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 biology, process engineering, and clinical translation....
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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 now showing performance data that DMSO cannot match.…
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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 industry for two decades is under pressure from every...
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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 biology and bioprocess engineering. He's not just optimizing…
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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 understanding of microbial physiology to avoid mistakes…
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ABOUT THIS SHOW
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
HOSTED BY
David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist
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Frequently Asked Questions
How many episodes does Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders have?
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders currently has 293 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders about?
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...
How often does Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders release new episodes?
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders publishes regularly with 293 episodes available. Check the episode list for the typical release schedule.
Where can I listen to Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders?
You can listen to Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.
Who hosts 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 is created and hosted by David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist.
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