Podcast Episodes
Back to Search231: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 1
Episode 231
Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions …
3 months, 2 weeks ago
230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 2
Episode 230
What if the future of sustainable manufacturing required no sugar feedstocks, generated minimal waste, and operated carbon-neutral from day one? Ocea…
3 months, 3 weeks ago
229: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 1
Episode 229
The chemicals industry remains locked into carbon-intensive, fossil-based manufacturing. Even engineered microbes like yeast or E. coli depend on exp…
3 months, 3 weeks ago
228: Media-Based Glycan Engineering for Biosimilars: Your Rapid Implementation Guide
Episode 228
How early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity…
4 months ago
227: Media-Based Glycan Engineering for Biosimilars: Achieving Reference Product Match
Episode 227
When your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperat…
4 months, 1 week ago
226: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 2
Episode 226
Hard-to-treat cancers like pancreatic ductal adenocarcinoma (PDAC) have long defied conventional therapies. Radiopharmaceuticals, combining targeted …
4 months, 1 week ago
225: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 1
Episode 225
Imagine treating cancer with the precision of a guided missile—delivering radioactive payloads directly to tumor cells. Radiopharmaceuticals are resh…
4 months, 2 weeks ago
224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 2
Episode 224
The cultivated meat industry has captured headlines and struggled with economics. Meanwhile, plant cell biomanufacturing is quietly solving the cost …
4 months, 2 weeks ago
223: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 1
Episode 223
What if the chocolate industry's reliance on equatorial farms—and the deforestation that comes with it—could be eliminated entirely? Plant cell biore…
4 months, 3 weeks ago
222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito - Part 2
Episode 222
What happens when we move beyond oversimplified cell cultures and truly embrace the complexity of human biology? In this episode of the Smart Biotech…
4 months, 3 weeks ago