Hope in a Dose: CGT Podcast | Ep 11 | CMC Foundations for FIH Success: Getting CGT-Ready from Day Zero

In this episode, we focus on building the right CMC foundation for cell and gene therapy success. From manufacturing variability and potency assays to comparability and cold chain logistics, the CMC story is often the story regulators focus on.Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at FortreaParticipant: Sanjay Jain, Executive Director of Global Regulatory Affairs Strategy at Fortrea

What this episode covers

In this episode, we focus on building the right CMC foundation for cell and gene therapy success. From manufacturing variability and potency assays to comparability and cold chain logistics, the CMC story is often the story regulators focus on. Host: Louise Kearney, Head of Cell and Gene Therapy, Strategy and Delivery at Fortrea Participant: Sanjay Jain, Executive Director of Global Regulatory Affairs Strategy at Fortrea

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How long is this episode of The Fortrea Podcast?

This episode is 17 minutes long.

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This episode was published on May 22, 2026.

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