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:
Get the 5-day CMC email course: https://smartbiotechscientist.com/#cmc
Visit the website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Episodes
280 episodes
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—...
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 Consult...
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 enoug...
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, wher...
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,...
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, ...
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 pr...
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 c...
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—ce...
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 Biote...
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...
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 indus...
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?E...
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...