Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.
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, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.
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:
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
245: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor Anderlei - Part 1
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Why do small-scale bioprocess experiments often fail to translate in scale-up despite “perfect” results on paper?
Tibor Anderlei, Chief Scientific Officer and leader of customer support at Kühner Shaker, has spent three decades solving an issue that frustrates CMC leaders and biomanufacturing teams worldwide. He pioneered online monitoring in shake flasks, co-founded AC Biotec, and now helps organizations avoid costly trial-and-error with high-throughput screening and orbital shaken bioreactors.
Topics discussed:
- Why orbital shaken bioreactors are fundamental to successful bioprocess development (03:11)
- The gap between educational practices and real-world bioreactor expertise (04:00)
- Tibor Anderlei’s journey from the Technical University of Aachen to pioneering online monitoring technology in shake flasks (04:27)
- Reasons why published shake flask and microtiter plate experiments often fail to be reproduced in other labs (09:47)
- Key parameters frequently omitted from publications—including shaking diameter—and their impact on experiment reproducibility (13:10)
- Practical considerations for using microtiter plates and tubes, including automation compatibility and critical shaking speeds (14:13)
- Common scale-up failures due to oxygen limitation and mismatched aeration rates between small-scale and bioreactor systems (22:22)
- The effect of bioreactor geometry, such as neck shape, on process ventilation and performance (24:49)
Smart insight: If scientists want scalable, reproducible success, the path starts with getting the details right—and keeping a sharp eye on both automation trends and the fundamentals of shaken cultures.
Listen to the full episode with Tibor Anderlei to unpack the real “missing links” in bioprocess reproducibility and how to bridge small-scale insight to CMC scale-up.
Building a robust scale-up strategy requires looking at the process from multiple angles—regulatory, digital, and operational. Listen to those previous episodes:
- Episode 03 - 04: How to Master Biotech Scale-up Without Guesswork with Leonardo Sibilio
- Episode 25-26: 9 Critical Steps for a Seamless Transition to Large-Scale Production
- Episode 231-232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann
- Episode 233-234: Why Most Bioprocess Automation Projects Fail with Anthony Catacchio
- Episode 237-238: High-Throughput Microbial Screening with Sebastian Blum
Connect with Tibor Anderlei:
LinkedIn: www.linkedin.com/in/tibor-anderlei-66342411/
Kühner Shaker website: www.kuhner.com
Shaking Technology Forum: www.shakingtechnology.com