Shear sensitivity is the silent challenge behind many advanced biomanufacturing modalities. Orbital-shaken bioreactors—often underestimated—may be a key enabler your CMC development is missing.

Tibor Anderlei, CSO at Kühner Shaker, joined David Brühlmann on the Smart Biotech Scientist Podcast to unpack the hidden physics behind bioprocess reproducibility and next-generation shaking technology. He has seen firsthand how overlooking fundamental parameters can derail scale-up and delay development timelines. In his role, Tibor is responsible for the customer interface—spanning sales, service, support, GMP topics, troubleshooting, marketing, and applied technology—with a focus on orbital shaking technology and small-scale cultivation support.

Topics discussed:

• The importance of measuring oxygen transfer rate (OTR) and carbon dioxide transfer rate (CTR) for reproducible bioprocesses—why DO is not sufficient (02:55)
• Real-time process analytical technology (PAT) for small-scale bioreactors, including microtiter plates and shake flasks (06:47)
• Pre-culture reproducibility: transferring at the right OTR and its impact on main cultures (07:56)
• Price sensitivity and scale-up challenges in cultivated meat—implications for media and equipment selection (10:36)
• Expansion of shaking technology to fields such as mixing, storage, and thawing, including applications in liquid crystal production (12:10)
• Leadership lessons from competing with bigger players: how smaller companies stay innovative, agile, and close to their customers (14:20)
• The significance of strong business partner relationships and trusting gut feeling in decision-making (16:32)
• Key advice for smart biotech scientists: careful definition of screening conditions and the use of online measurement tools at small scale (18:09)
• Accessible resources for mastering shaken bioreactor techniques, including webinars and direct contact with Tibor Anderlei (19:38)

Smart insight:

Treat small-scale shaken systems as real bioreactors and define screening conditions carefully from the start. Using online measurement tools even at early stages provides critical visibility and helps ensure that results are reproducible and scalable.

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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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

One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

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When a single mismanaged tech transfer threatens an entire development program, pressure on CMC leaders and bioprocess teams is intense. The truth? Tech transfers aren’t a black box. They’re complex, but solvable with the right mindset and playbook.

In this episode, David Brühlmann explores the practical side of tech transfer and scale-up within the biotech industry. With more than 15 years of experience, he shares personal stories and industry-tested frameworks that help demystify the complexities of transferring technologies between sites or organizations. Instead of focusing solely on technical details, he emphasizes the crucial human and organizational factors that often decide project success or failure.

Key topics discussed:

• How mapping and managing stakeholders can resolve hidden issues and accelerate projects (01:55)
• Case studies highlighting the importance of environmental factors — like light exposure — in process performance and troubleshooting (05:50)
• A mass transfer checklist for bioprocess scale-up, with specific focus on equipment-related parameters (07:09)
• The build vs. outsource dilemma: how to choose what to keep in-house and what to partner out, depending on company strategy and project phase (08:05)
• A 12-week tech transfer preparation protocol, covering foundations, risk mitigation, and execution readiness (10:16)
• Lessons on leadership, prioritization, and effective delegation to avoid personal and organizational bottlenecks (13:28)

Whether you're overseeing a complex CMC program, navigating CDMO relationships, or planning your next scale-up, this episode offers concrete steps to cut through confusion and deliver results.

If you’re interested in the ideas discussed, here are some of the guests David referenced in this episode.

• Episodes 91 - 92: Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik Volger
• Episodes 79 - 80: Think Before You Build: Holistic Approaches to Biotech Facility Design with Alfredo Martínez Mogarra
• Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
• Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene Lee

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