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

298: 10,000 Structures Are Not Enough: The Data Gap Limiting De Novo Antibody Design with David Younger - Part 2

The entire public record of antibody affinity data comes to about half a million measurements, and by David Younger's estimate, upwards of 75% of it is AlphaSeq data

297: 10,000 Structures Are Not Enough: The Data Gap Limiting De Novo Antibody Design with David Younger - Part 1

The Protein Data Bank holds about 10,000 antibody-antigen structures and grows by roughly 1,000 a year. David Younger's scaling work suggests that generalizable de n

296: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 2

Cardiovascular disease has long been managed by slowing its relentless progression. But Matthew O'Connor, CEO of Scientific Affairs at Cyclarity Therapeutics, is bet

295: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 1

Why does CMC development still expect every drug to be one molecule with one peak, when new therapeutics don't always fit neatly into existing regulatory or chemical

294: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 2

Scale-up doesn't fail because the science was wrong. It fails because a cell's environment in a shake flask has little in common with its environment in a biore

293: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 1

You've perfected your process at the bench. Now comes the part that keeps CMC scientists up at night: will it still work at 2,000L? Right now, most teams find out th

292: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 2

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 mone

291: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 1

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

290: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 2

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 brick

289: Batch-to-Batch Variability Is a Design Failure, Not the Norm with Sandra Núñez - Part 1

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 N

288: Why the Cell Line Is the CMC Decision You Don't Get to Undo with Sigma Mostafa - Part 2

Manufacturability challenges in biotech are becoming more complex as therapies become more potent, formats diversify, and timelines compress across the industry. On this

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 beca

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? B

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 fr

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

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

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 membra

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 shar

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—bo

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 ex