Weekly CMC and biomanufacturing insights for process development scientists and biotech founders — from people who have done it at scale.
2,500+ monthly downloads
Weekly CMC and biomanufacturing insights for process development scientists and biotech founders — from people who have done it at scale.
2,500+ monthly downloads
Biotech founders and CMC leaders make high-stakes CMC development and manufacturing decisions without the frameworks they need. Most content out there is too academic to apply or too superficial to trust.
70% of FDA Complete Response Letters trace back to CMC failures. Regulatory rejection is not a rare event; it is the most common failure mode in biologics development.
A single CDMO mistake can compound into $2M+ in lost time, rework, and delayed revenue — and most founders don’t see it coming until it’s too late.
Programs routinely lose 6–18 months to avoidable tech transfer failures, batch deviations, and misaligned CDMO expectations.
70% of FDA Complete Response Letters trace back to CMC failures. Regulatory rejection is not a rare event; it is the most common failure mode in biologics development.
A single CDMO mistake can compound into $2M+ in lost time, rework, and delayed revenue — and most founders don’t see it coming until it’s too late.
Programs routinely lose 6–18 months to avoidable tech transfer failures, batch deviations, and misaligned CDMO expectations.
Decision frameworks for process development, scale-up, technology innovation, CDMO management, and process validation.
Deep dives into mAbs, ADCs, cell and gene therapies, biosimilars — each with distinct CMC challenges.
AI-driven bioprocessing, digital twins, continuous manufacturing, and predictive scale-up — where the field is heading.
Dr. David Brühlmann brings 20 yrs of biomanufacturing experience, a PhD in glycoengineering, and deep industry knowledge.
Every guest has navigated these decisions at scale — not in theory.
Deep dives into mAbs, ADCs, cell and gene therapies, biosimilars — each with distinct CMC challenges.
AI-driven bioprocessing, digital twins, continuous manufacturing, and predictive scale-up — where the field is heading.
Dr. David Brühlmann brings 20 yrs of biomanufacturing experience, a PhD in glycoengineering, and deep industry knowledge.
Every guest has navigated these decisions at scale — not in theory.
Join hundreds of biotech executives, CMC leads, and research scientists who rely on our dialogues to navigate the complexities of modern drug development.
"The depth of discussion on CMC regulations and manufacturing scalability is unparalleled. This podcast has become an essential briefing for our entire technical team."
QA Manager
"I've been listening to your 'Smart Biotech Scientist' podcast on morning dog walks recently and have to say I really enjoy it. Guests are always very engaging, and the two-part episodes are really well structured."
This is a must-listen podcast to learn about Biotech and Biopharma. It quickly became my top 3 playlist.
Lead Research Analyst
"The depth of discussion on CMC regulations and manufacturing scalability is unparalleled. This podcast has become an essential briefing for our entire technical team."
QA Manager
"I've been listening to your 'Smart Biotech Scientist' podcast on morning dog walks recently and have to say I really enjoy it. Guests are always very engaging, and the two-part episodes are really well structured."
This is a must-listen podcast to learn about Biotech and Biopharma. It quickly became my top 3 playlist.
Lead Research Analyst
"I like the depth of the conversations and also that the episodes have the perfect length for my commute to work."
Apple Podcast Review
"As someone involved in bio process development, I appreciate the quality of this podcast. David has done an excellent job organizing the content, framing the topics and sharing his personal enthusiasm. The overall result is an inspiring resource for the community of people involved in the bio processing industry."
R&D Director
Dr. David Brühlmann is a bioprocess innovator who specializes in transforming high-potential biotech discovery into scalable, investor-ready manufacturing reality. With over 15 years of experience, he has led global technology transfers and scaled processes up to 15,000 L for commercial production across Europe, North America, and Asia.
David’s work ensures that life-saving therapies don’t just succeed in the lab, but reach patients through precision-engineered, large-scale execution.
As the host of the Smart Biotech Scientist podcast, David has interviewed over 200 industry leaders, maintaining a strategic network that bridges the gap between complex CMC strategy and capital partners. He focuses on de-risking the path to Series A/B funding by aligning scientific innovation with rigorous, globally accessible manufacturing roadmaps.
Dr. David Brühlmann is a bioprocess innovator who specializes in transforming high-potential biotech discovery into scalable, investor-ready manufacturing reality. With over 15 years of experience, he has led global technology transfers and scaled processes up to 15,000 L for commercial production across Europe, North America, and Asia.
David’s work ensures that life-saving therapies don’t just succeed in the lab, but reach patients through precision-engineered, large-scale execution.
As the host of the Smart Biotech Scientist podcast, David has interviewed over 200 industry leaders, maintaining a strategic network that bridges the gap between complex CMC strategy and capital partners. He focuses on de-risking the path to Series A/B funding by aligning scientific innovation with rigorous, globally accessible manufacturing roadmaps.
Sign up for the free 5-day CMC email series. Each day, you’ll get one actionable framework to avoid the most common — and most expensive — CMC mistakes.
Explore 200+ podcast episodes featuring real CMC and biomanufacturing leaders sharing how they’ve navigated scale-up, tech transfer, and regulatory challenges.
Walk into your next CMC review, board meeting, or CDMO negotiation with the frameworks and confidence to make the right call.
Sign up for the free 5-day CMC email series. Each day, you’ll get one actionable framework to avoid the most common — and most expensive — CMC mistakes.
Explore 200+ podcast episodes featuring real CMC and biomanufacturing leaders sharing how they’ve navigated scale-up, tech transfer, and regulatory challenges.
Walk into your next CMC review, board meeting, or CDMO negotiation with the frameworks and confidence to make the right call.
Smart Biotech Scientist is the only podcast anchored specifically on CMC and biomanufacturing execution — the hard, expensive, high-stakes work of turning a promising molecule into a scalable, GMP-ready, regulatory-approved therapy.
Every week, host Dr. David Brühlmann speaks with process development scientists, CMC leads, manufacturing executives, and biotech founders who share practical frameworks for scale-up, technology transfer, CDMO selection and management, process validation, upstream and downstream development, and cost of goods optimization.
Whether you are preparing your first IND, navigating a CDMO relationship, or trying to reduce manufacturing risk before your Series A, Smart Biotech Scientist delivers the peer-level insight you need to move faster with less risk.
