Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
von David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist
- wöchentlichErscheinungsrhythmus
- 22 mintypische Länge
- vor 3 Tagenletzte Folge
Folgenzu den neuesten
240: Continuous Microbial Manufacturing: From Genetic Instability to 40-Day E. coli Processes with Juergen Mairhofer - Part 2
Why do CDMOs keep building bigger stainless-steel facilities while their margins erode and Asian competitors undercut them on price? And what happens when big pharma decides to stop outsourcing altogether? The business model that sustained
239: Continuous Microbial Manufacturing: From Genetic Instability to 40-Day E. coli Processes with Juergen Mairhofer - Part 1
What if continuous microbial manufacturing wasn't a pipe dream, but a reality quietly reshaping the foundations of bioprocessing? Meet Juergen Mairhofer, CEO of enGenes Biotech GmbH and a scientist with a rare dual fluency in molecular biol
238: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 2
For many biotech innovators, high-throughput screening platforms promise faster discoveries and streamlined workflows. Yet beneath the surface, the reality is more demanding, requiring hands-on expertise, careful assay design, and a sharp u
237: High-Throughput Microbial Screening: Avoiding Early Mistakes That Derail Scale-Up with Sebastian Blum - Part 1
Why do so many promising biotech ideas stall long before they reach the clinic or marketplace? For many, the answer lies hidden in the earliest phase of bioprocess development: upstream processing. It’s where strain selection, media optimiz
236: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen - Part 2
For years, mammalian cells and microbial systems have dominated the biotech landscape, shaping the economics and access to life-saving biologics. Yet, in countries where capital and infrastructure are limited, those gold-standard systems br
235: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen - Part 1
Imagine producing life-saving antibodies or vaccines not in sprawling stainless steel facilities, but in sunlit greenhouses, inside living, breathing plants. Waranyoo Phoolcharoen, Co-Founder and CTO of Baiya Phytopharm and Professor at Chu
234: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 2
Picture a new bioprocess automation project: ambitious, expensive, and packed with promise. But after months of development, your team discovers a flaw that could have been caught with a simple mockup and a few sticky notes on a whiteboard.
233: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio - Part 1
Many bioprocess automation projects fail, not because the technology is wrong, but because no one clearly defined the problem before buying the robot. In this episode, David Brühlmann sits down with Anthony Catacchio, CEO of Product Insight
232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 2
How solid is your CMC foundation—and what happens if it cracks under pressure? David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Fer
231: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 1
Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later. Henri Kornmann has spent tw
230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 2
What if the future of sustainable manufacturing required no sugar feedstocks, generated minimal waste, and operated carbon-neutral from day one? Ocean-derived cyanobacteria are making this possible—but the path from promising strain to prof
229: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran - Part 1
The chemicals industry remains locked into carbon-intensive, fossil-based manufacturing. Even engineered microbes like yeast or E. coli depend on expensive sugar feedstocks while generating significant waste. What if a photosynthetic organi
228: Media-Based Glycan Engineering for Biosimilars: Your Rapid Implementation Guide
How early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity from initial process characterization. Deferring glycosylation characterization until afte
227: Media-Based Glycan Engineering for Biosimilars: Achieving Reference Product Match
When your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperature shifts that compromise titer, kifunensine supplementation that requires extensive regul
226: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 2
Hard-to-treat cancers like pancreatic ductal adenocarcinoma (PDAC) have long defied conventional therapies. Radiopharmaceuticals, combining targeted therapy with diagnostic power, are creating new opportunities in precision oncology. Host D
225: Mastering Radiopharmaceutical Development: Preclinical Model Selection for Clinical Success with Bryan Miller - Part 1
Imagine treating cancer with the precision of a guided missile—delivering radioactive payloads directly to tumor cells. Radiopharmaceuticals are reshaping cancer diagnostics and therapy by pairing tumor-targeting molecules with radioisotope
224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 2
The cultivated meat industry has captured headlines and struggled with economics. Meanwhile, plant cell biomanufacturing is quietly solving the cost equation and approaching commercial launch. The question isn't whether cellular agriculture
223: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang - Part 1
What if the chocolate industry's reliance on equatorial farms—and the deforestation that comes with it—could be eliminated entirely? Plant cell bioreactors are doing that, producing real cacao without a single tree. But this isn't just abou
222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito - Part 2
What happens when we move beyond oversimplified cell cultures and truly embrace the complexity of human biology? In this episode of the Smart Biotech Scientist Podcast, we explore how advanced 3D cell models are reshaping preclinical resear
221: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito - Part 1
What if the failure rate in clinical trials isn't about picking the wrong drug candidates—but about testing them in the wrong models? When you move cells from a 2D culture plate into a bioreactor, you're not simply scaling volume. You're fu
220: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy Lionberger - Part 2
The biotech industry stands on the verge of a radical transformation thanks to artificial intelligence (AI) and machine learning (ML). But even the most sophisticated algorithms are only as smart as the data feeding them. David Brühlmann si
219: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy Lionberger - Part 1
Antibody therapeutics have transformed modern medicine, but for many scientists, developing new candidates still feels like searching for a needle in a haystack—a slow, expensive, and unpredictable process. Structural biology and high-throu
218: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa - Part 2
For generations, silkworm pupae were discarded as waste from silk production. Now, KAICO is proving these organisms can function as highly efficient protein factories—producing complex vaccine antigens at yields and costs that challenge con
217: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa - Part 1
For over 4,000 years, silkworms have connected civilizations through ancient trade routes. Now, KAICO Ltd., a Japanese biotech spin-off from Kyushu University, is transforming these creatures into living bioreactors capable of producing com
216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov - Part 2
Biomanufacturing has always dealt with the challenge of turning vast, complex datasets and intricate production steps into life-changing therapies. But when batch records multiply and process deviations loom, how do biotech teams make sense
215: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov - Part 1
Across biotech labs, researchers swim in oceans of process data: sensor streams, run records, engineering logs, and still, crucial decisions get stuck in spreadsheets or scribbled into fading notebooks. The challenge isn’t having enough inf
214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari - Part 2
Computational methods can predict stability issues before the lab. But how do you actually implement these approaches in your formulation workflow? From excipient selection to long-term stability prediction, in silico tools are transforming
213: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari - Part 1
What if you could predict formulation failures before ever touching a pipette? Computational approaches are revolutionizing biologics development, replacing trial-and-error experimentation with predictive intelligence that catches stability
212: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo - Part 2
What happens when cell therapy innovation meets real patient urgency? In this conversation, the barriers between scientist and patient all but vanish, bringing clarity—and a new sense of mission—to some of the biggest problems facing advanc
211: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo - Part 1
Real progress in cell and gene therapy shouldn’t be measured solely by scientific innovation, but by whether those innovations actually reach the patients who need them most. In this episode, David Brühlmann sits down with Jesús Zurdo, a sc
