Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders
The go-to CMC and bioprocessing podcast for process development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics.
Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.
This podcast is for you if:
- You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership
- You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness
- You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny
- You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources
What you will learn:
CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling and manufacturing economics, continuous manufacturing and Industry 4.0 in biopharma, biologics modalities including mAbs, ADCs, and cell and gene therapies.
Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.
New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.
Next Steps:
Book a free assessment to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/assessment
Fast-track bioprocess development with expert guidance: https://bruehlmann-consulting.com
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Episodes
239 episodes
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 under...
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Episode 238
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13:59
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 optimizatio...
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Episode 237
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19:42
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 bring ...
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Episode 236
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18:50
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 C...
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Episode 235
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26:35
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. Thi...
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Episode 234
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22:06
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 Insig...
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Episode 233
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21:07
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 F...
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Episode 232
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18:16
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 ...
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Episode 231
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19:39
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 profitab...
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Episode 230
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19:00
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 organism c...
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Episode 229
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25:11
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 after ti...
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Episode 228
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15:52
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 regulator...
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Episode 227
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16:34
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...
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Episode 226
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16:00
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 radioisotopes fo...
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Episode 225
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17:55
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 can...
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Episode 224
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16:40
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 about ch...
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Episode 223
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27:50
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 research—r...
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Episode 222
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15:23
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 ...
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Episode 221
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19:45
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 ...
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Episode 220
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17:43
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-throughpu...
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Episode 219
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26:55
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 convent...
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Episode 218
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17:56
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 complex...
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Episode 217
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25:29
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 of ...
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Episode 216
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18:33
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 informa...
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Episode 215
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21:34
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 how...
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Episode 214
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14:49