CMC Progression from Early to Late Phase...

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Presented by

Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest

About this talk

Full Title: CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy The principles for developing traditional biologics are well established, but do not always translate well to cell and gene therapy products.  Creative yet practical adaptations are necessary to advance gene therapy programs toward licensure.  During this presentation we will explore three key areas where practical adaptations are required: Building toward the commercial process: change control and managing product evolution for non-traditional development pathways, comparability challenges and clinical exposure Maturation of analytics – the level of product understanding expected as programs advance, method advancement from early to late phase, evolving regulatory expectations Finding the right partners – finding the right match in terms of not just technical ability, but also phase-appropriate GMP compliance and client service infrastructure; the impact of the Covid-19 pandemic on material and service providers

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