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

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

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

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

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

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

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 proble

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 environm