All Episodes

287: Why the Cell Line Is the CMC Decision You Don't Get to Undo with Sigma Mostafa - Part 1

286: Why Your Dormant Omics Data Is Worth More Than the Data You'll Generate Next with Nathan Lewis - Part 2

285: Why Your Dormant Omics Data Is Worth More Than the Data You'll Generate Next with Nathan Lewis - Part 1

284: Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection with Kent Rapp - Part 2

283: Detecting 1 in 100,000 Cells: DNA Barcoding for Smarter Clone Selection with Kent Rapp - Part 1

282: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra Kumar - Part 2

281: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra Kumar - Part 1

280: Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines with Christopher Locher - Part 2

279: Why Nanovesicles Outperform Exosomes: Scalable Drug Delivery Beyond Injectable Vaccines with Christopher Locher - Part 1

278: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 2

277: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 1

276: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 2

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

274: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 2

273: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 1

272: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 2

271: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 1

270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 2

269: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 1

268: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 2

267: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 1

266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 2

265: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 1

264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 2

263: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 1

262: How to Stop Defaulting to CHO: An Evidence-Based Host Selection Framework for Biologics

261: Why CHO Is Still Winning (and the 5 Platforms That Beat It in Specific Contexts)

260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 2

259: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 1

258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2

257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

256: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 2

255: Is Bioprocess Education Keeping Up With New Tech? The Training Gap Industry Cannot Afford to Ignore with Steffen Kreye - Part 1

254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee - Part 2

253: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee - Part 1

252: How to Use Media Supplements to Tailor Biosimilar Glycan Quality to Your Reference Product in Two Rounds

251: Why a Single Large DoE Fails Biosimilar Glycan Optimization — And the Parallel Screening Method That Actually Works

250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez - Part 2

249: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez - Part 1

248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 2

247: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi - Part 1

246: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 2

245: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 1

244: Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMC

243: Turn Tech Transfer from a Gamble into a Managed Process: The 6-Pillar Biologics Scale-Up Framework

242: DMSO in Cell Therapy: Why Viability Scores Hide the Real Toxicity with Steve Oh - Part 2

241: DMSO in Cell Therapy: Why Viability Scores Hide the Real Toxicity with Steve Oh - Part 1

240: Continuous Microbial Manufacturing: From Genetic Instability to 40-Day E. coli Processes with Juergen Mairhofer - Part 2

239: Continuous Microbial Manufacturing: From Genetic Instability to 40-Day E. coli Processes with Juergen Mairhofer - Part 1

238: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 2

237: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 1

236: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen - Part 2

235: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen - Part 1

234: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 2

233: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 1

232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 2

231: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 1

230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 2

229: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 1

228: Media-Based Glycan Engineering for Biosimilars: Your Rapid Implementation Guide

227: Media-Based Glycan Engineering for Biosimilars: Achieving Reference Product Match

226: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 2

225: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 1

224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 2

223: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 1

222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito - Part 2

221: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito - Part 1

220: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy Lionberger - Part 2

219: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy Lionberger - Part 1

218: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa - Part 2

217: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa - Part 1

216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov - Part 2

215: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov - Part 1

214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari - Part 2

213: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari - Part 1

212: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo - Part 2

211: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo - Part 1

210: From Batch to Continuous: Building Innovation Culture in Conservative Biotech Environments with Irina Ramos - Part 2

209: From Batch to Continuous: Building Innovation Culture in Conservative Biotech Environments with Irina Ramos - Part 1

208: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom Rizzo - Part 2

207: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom Rizzo - Part 1

206: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 2

205: Process Economics Decoded: How to Model Biomanufacturing Costs From Clinical to Commercial Scale with Niklas Jungnelius - Part 1

204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 2

203: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel Galbraith - Part 1

202: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 2

201: Fighting Antimicrobial Resistance: How AI Cuts Phage Therapy Access from 6 Months to 5 Days with José Bila - Part 1

200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 2

199: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development - Part 1

198: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 2

197: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda Hoertz - Part 1

196: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 2

195: Monolithic Chromatography Innovations: Solving High-Capacity Purification for Gene Therapy Vectors with Alois Jungbauer - Part 1

194: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 2

193: Viral Vector CDMO Mastery: Singapore's Answer to Cell and Gene Therapy Supply Shortages with Lucas Chan - Part 1

192: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 2

191: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas Castan - Part 1

190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 2

189: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 1

188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 2