What if the hidden cost of your bioprocess lies not in the technology, but in what you don’t document?

Too often, biotech teams discover too late that their “proven” process is just an illusion, propped up by undocumented tricks and missing critical parameters. In this episode, David Brühlmann strips down the assumptions behind scale-up and tech transfer, exposing the silent risks that threaten CMC milestones and market launches alike. After 15 years guiding biotech projects from bench to clinic, he’s felt the pain of process gaps, regulatory curveballs, and million-dollar mistakes. Here, he turns that experience into a tactical guide designed to save you from the same pitfalls.

In this episode, you’ll learn about:

• The 6-pillar approach to turning tech transfer into a managed process, rather than a gamble (03:09)
• Why mass transfer physics and factors like kLA are critical—and how they can make or break a process at scale (05:12)
• The importance of analytical comparability, including the common blind spots in sampling plans and method validation (07:19)
• Establishing a solid Quality by Design (QbD) foundation and defining critical quality attributes before transfer, not after failures (08:33)
• Stakeholder management and why non-technical challenges often derail projects (with more on this in Part 2) (10:09)
• Evaluating CDMO partners: What selection criteria really matter for long-term success and risk mitigation (11:03)
• Strategic decision-making: Building core capabilities versus outsourcing, and how to avoid unnecessary costs and delays (12:22)

This episode sets the stage for Part 2, where David Brühlmann will share practical stories and detailed frameworks for real-world implementation. If you manage bioprocess scale-up, tech transfer, or CMC development, you’ll find plenty of actionable insights to apply in your own work.

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

Support the show