The 24 months before CGT launch

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Every second counts: what real cell and gene therapy launches teach us

For cell and gene therapies (CGTs), the path from a successful clinical readout to reliable commercial supply remains one of the most technically and operationally demanding transitions in the pharmaceutical industry. The final 24 months before launch is a critical window that is still often underestimated by the teams navigating it. During this period, processes must become robust and scalable, tech transfer and validation must be completed, manufacturing capacity secured, and supply chains prepared to support commercial demand.

This webinar will cover the practical aspects of preparing for CGT commercial approval and manufacturing, based on real lessons from launched programs. The session will be delivered by Lonza’s Global Head of Launch Excellence and Digitalization for Specialized Modalities.

If commercialization is part of your roadmap, whether you are early in development or already planning late-stage manufacturing, this webinar will help you prepare for the realities of commercial manufacturing and supply.

Learning points:

Understanding the transition from clinical to commercial manufacturing, including process robustness, validation, and GMP expectations.
Practical insights into tech transfer and scale-up challenges and how to avoid common late-stage delays and comparability risks.
Key operational priorities in the final 24 months before launch, including raw materials, vector supply, capacity, and supply chain planning.
How to prepare processes for commercial scale and cost of goods, including automation and process industrialisation.

Alexander Huber, PhD

Senior Director, Commercial and Strategic Programs at Lonza

Dr. Alexander Huber is a seasoned executive with over 12 years of experience in the advanced therapies sector, spanning both early and late-stage cell and gene therapy programs. He has played a key role in the development and commercialization of one of the first approved CAR-T therapies, including leading the ramp-up of a commercial manufacturing site in Asia.

He currently leads the global Launch Excellence team within Lonza’s Specialized Modalities platform, supporting the transition of advanced therapies from late-stage development to commercial supply for a global customer base. In addition, he serves as an academic editor for the international journal Swiss Medical Weekly.

Dr. Huber holds a PhD in molecular biology from ETH Zurich, where his research focused on gene therapy approaches for neurological disorders. He is based in Rheinfelden, Switzerland.

In 35 Days

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