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

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