232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann - Part 2

How solid is your CMC foundation—and what happens if it cracks under pressure? David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His “house building” approach demystifies CMC’s complexity, showing why early diligence paired with regulatory fluency and scientific insight pays dividends for years. Tune in to hear Henri’s practical wisdom distilled through real-world analogies: Building a strong CMC foundation in early phases and why later fixes can be costly or impossible (02:45) Scaling up: supplying Phase 3 with the final commercial process, including robustness and supply chain strategies such as dual sourcing critical raw materials (03:23) Process validation explained: FDA’s three stages, from control strategy justification to continued verification (05:15) Process Performance Qualification (PPQ): what it is, how many batches are needed, and optimizing timing (07:43) Handling lifecycle changes: maintaining process control, adapting to deviations, and improving systems after regulatory approval (09:34) Managing teams, stakeholders, and cross-functional collaboration in CMC programs (11:49) Importance of good project management, access to scientific expertise, and interpreting guidelines for your specific program (12:27) The “half scientist, half lawyer” analogy for mastering both technical and regulatory aspects (15:08) Smart insight: Never underestimate CMC. If you do, you will pay for it later. If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes: Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC Development Episodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene Lee Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner Connect with Henri Kornmann: LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869 Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show