Couverture de 244: Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMC

244: Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMC

244: Prevent the Delays That Derail Biologics Tech Transfer: 12-Week Protocol for CMC

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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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