Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

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 hurdles for patients, especially when the economics of essential medicines seem stacked against them. Eric...

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 not just the science, but the business model itself. With a background in nonprofit fundraising—not dr...

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 challenges and unlock broader global access. Farlan Veraitch, founder and Chief Scientific Officer at Ori Biotec...

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 everything from product yield to therapeutic potency. This episode features Farlan Veraitch, founder and C...

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 Thermo Fisher Scientific. With years spent guiding automation and digital lab transformation projec...

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 Scientific with 25 years of experience at the intersection of data, automation, and laboratory science,...

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 scientists navigating host cell decisions today. David Brühlmann moves past simplistic "replacement&qu...

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 strengths—and their limits—in today’s biomanufacturing environment. Topics Discussed The historical domin...

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 Director at Foresite Capital, joined the Smart Biotech Scientist Podcast to dissect what’s really driving f...

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 dozens of biotech companies, he’s seen first-hand how world-class discoveries become market-ready solutio...

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 Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefe...

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 everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams ali...

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 problem. Steffen Kreye has seen it from both sides. As former upstream development lead at Ba...

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 into industry ready to run a bioreactor, not just describe one. His argument is direct: hands-on lab co...

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 cells. In Part 2, the conversation shifts to the larger ambition: using those cells not just to treat di...

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 tissue that is otherwise discarded, sit at a unique biological intersection: earlier than MSCs, free fr...

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 development can take over 12 months, while the parallel group design massively accelerates d...

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 development. David Brühlmann breaks down a practical, parallel framework for rapid compound screening that a...

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 TIL production to regions with no current access, and the next-generation engineered approaches redefinin...

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 one donor and fail completely with the next. In this episode, she explains why starting material variabil...

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 the investigation that identified NDMA as a degradation product of ranitidine — findings the FDA for...

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 building companies at the intersection of analytical chemistry and drug development. His investi...

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 unpack the hidden physics behind bioprocess reproducibility and next-generation shaking technology. He...

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 teams worldwide. He pioneered online monitoring in shake flasks, co-founded AC Biotec, and now helps organ...

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 practical side of tech transfer and scale-up within the biotech industry. With more than 15 years of exp...