Loading...

PODCAST

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

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

science life sciences

All Episodes

22:25

292: The Fool's Game That Became Standard Practice:...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/10/01

Biotech founders often pour everything into building the “perfect” product only to realize their real customers have walked out the door. Chasing perfection can burn money and stall even the most promising CMC innovations. In this episode, David Brühlmann continues his conversation with biotech entrepreneur and investor John Bonham-Carter. John shares his insights on the realities of building and scaling successful biotools companies, from the challenges of fundraising and the importance of a...

en-us

30:36

291: The Fool's Game That Became Standard Practice:...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/29

Biotech loves talk of disruptive technology, but few have repeatedly shifted the industry's direction. This episode of the Smart Biotech Scientist Podcast focuses on an idea once dismissed as a fool's game: process intensification through perfusion—now the backbone of leading biomanufacturing platforms. Meet John Bonham-Carter, a serial entrepreneur whose fingerprints are on some of biotech's most transformative tools. From putting the once-ignored ATF system and perfusion on the global stage...

en-us

20:04

290: Batch-to-Batch Variability Is a Design Failure,...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/24

What if building a world-class biotech company didn’t require owning a single piece of manufacturing equipment or even a lab of your own? Most startups obsess over bricks, mortar, and stainless steel. Not Sandra Núñez. She’s challenging the status quo as CEO of Amela Biosciences by running a “virtual plant” model: zero in-house production, everything outsourced, and agility baked into every decision. It’s a bold experiment in redefining what a biotech company can look like. One that’s already...

en-us

19:26

289: Batch-to-Batch Variability Is a Design Failure,...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/22

Batch-to-batch variability isn’t just a minor annoyance in bioprocess development; it’s often a systemic design flaw hiding in plain sight. That’s the challenge Sandra Núñez, CEO of Amela Biosciences, set out to eliminate. Drawing on 15 years across Lonza, Medinova, Baxalta, and Biogen, she’s engineered a new generation of animal-free, recombinant protein matrices that promise researchers experimental consistency on demand. Topics discussed: The widespread issue of batch-to-batch variability ...

en-us

21:45

288: Why the Cell Line Is the CMC Decision You Don't...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/17

Manufacturability challenges in biotech are becoming more complex as therapies become more potent, formats diversify, and timelines compress across the industry. On this episode, David Brühlmann sits down with Sigma Mostafa, Chief Scientific and Technology Officer at KBI Biopharma. Sigma brings deep expertise in early-stage CMC decision-making and has guided countless programs—from upstart startups to established pipelines—through the traps and trade-offs of process development. Her ground-fl...

en-us

18:10

287: Why the Cell Line Is the CMC Decision You Don't...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/15

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 Brühlmann spoke with Sigma Mostafa, Chief Scientific and Technology Officer at KBI Biopharma. She’s spent 25+ years converting early-stage discoveries into commercial biomanufacturing success and she’...

en-us

17:39

286: Why Your Dormant Omics Data Is Worth More Than...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/10

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 unpredictability of post-translational modifications. Nathan Lewis, GRA Eminent Scholar at the Center for Molecular Medicine, Complex Carbohydrate Research Center, and Department of Biochemistry and Molecular Biolo...

en-us

30:26

285: Why Your Dormant Omics Data Is Worth More Than...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/08

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 Research Center, and Department of Biochemistry and Molecular Biology at the University of Georgia, has a clear message: actionable data is now within reach thanks to hybrid modeling, advanced study design, ...

en-us

20:47

284: Detecting 1 in 100,000 Cells: DNA Barcoding for...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/03

“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 Podcast to address that skepticism head-on, unpack how subclone variability and bispecific antibody purity concerns shape customer trust, and share what it actually took to move Biolinco from a Johns Ho...

en-us

21:53

283: Detecting 1 in 100,000 Cells: DNA Barcoding for...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/09/01

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 a 96-well plate turns into a dud when it reaches the bioreactor. That disconnect costs time, money, and promising therapies. This week, host David Brühlmann welcomes Kent Rapp, Co-founder and CEO of B...

en-us

19:20

282: When Your Delivery Vehicle Contains a Membrane...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/27

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 the agency's problem regardless of what you call it. Proteolipid vehicles (PLVs), the platform Jitendra Kumar works on as Lead Scientist for Chemistry and Process Development at Entos Pharmaceuticals,...

en-us

19:22

281: When Your Delivery Vehicle Contains a Membrane...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/25

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 degraded. Endosomal escape is where a large share of the dose is lost, and it is why delivery, not the genetic construct, is usually the thing that limits the therapy. Lipid nanoparticles carry a second const...

en-us

16:21

280: Why Nanovesicles Outperform Exosomes: Scalable...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/20

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, and even global vaccine delivery. This week, David Brühlmann welcomes Christopher Locher, CEO and Co-founder of Versatope Therapeutics. Christopher has shaped the translation of novel vesicle technol...

en-us

22:16

279: Why Nanovesicles Outperform Exosomes: Scalable...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/18

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 where oral vaccines and modular, on-demand manufacturing aren’t just possibilities, but standard practice. Christopher Locher, CEO and Co-founder of Versatope Therapeutics, brings decades of experience i...

en-us

18:44

278: Your Bioprocess Data Already Holds 35% More...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/13

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 process you run today is already governed by a mathematical model, fitted once at small scale during process characterization and then left untouched for years, even as the process shifts. Part 1 sep...

en-us

26:50

277: Your Bioprocess Data Already Holds 35% More...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/11

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 Scientist and CMC Consultant at Körber Pharma, breaks down what a digital twin actually is, where modeling pays back fastest across the product lifecycle, and how to tell a real business case from an expe...

en-us

17:54

276: From Lab-Scale Molding to GMP: Manufacturing a...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/06

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 Brühlmann welcomes back Eva-Maria Balet, whose journey spans tissue engineering research at EPFL to leading Regenosca through first-in-human trials, fundraising, and an executive MBA completed while running...

en-us

16:39

275: From Lab-Scale Molding to GMP: Manufacturing a...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/08/04

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 of Regenosca. Trained at EPFL, Eva-Maria brought her fascination with cellular "factories" from academia straight into entrepreneurship. Rather than chasing elegant science for its own sake, she ...

en-us

16:55

274: Engineering iPSC Neurons for Parkinson's: From...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/07/30

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 constraint Bilal Fares faces as CEO and co-founder of AzureCell, the University of Geneva spin-off engineering neuroprotective iPSC neurons for Parkinson's disease. In Part 2, he walks through how hi...

en-us

20:47

273: Engineering iPSC Neurons for Parkinson's: From...

Smart Biotech Scientist | The CMC and Bioprocessing... ·

2026/07/28

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, neuroscience entrepreneur and co-founder of AzureCell, is translating a University of Geneva discovery into a genetically engineered iPSC platform built to solve it: neurons that don't just replace wha...

en-us

260 results

Similar Podcasts

Beyond the Divide

Koala Moon

The SCP Experience

Dr. NoSleep Studios

John Michael Godier"s Event Horizon

John Michael Godier

La Science CQFD

France Culture

A Moment of Science

Indiana Public Media