CMC Progression from Early to Late Phase...

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

Related topics:

More from this channel

Upcoming talks (17)
On-demand talks (262)
Subscribers (24984)
BioPharma Webinars aims to keep its 30,000 readers abreast of all developments in the areas of Drug Development, Drug Delivery, Manufacturing, Quality Assurance, Outsourcing and Regulatory Affairs, with only the highest quality articles, written by the most respected authors, associated with only end-user companies. This ensures that the information will always be guaranteed to remain timely, informative and above all totally unbiased.