Driving Safety in Cell & Gene Therapy: Unlocking NGS and Regulatory Synergy for Maximum Impact

In this webinar, Tracie Fradet, Associate Director of Cytogenomics at the Astellas Institute for Regenerative Medicine, explains how her team built and operationalized a GMP-ready NGS platform to support safety testing in cell and gene therapy. You will learn how validated NGS workflows are applied to adventitious agent detection and variant analysis, and how early, structured engagement with regulatory authorities informs method design, validation strategy, and system life cycle management.

This talk is part of Genedata’s Open Forum series on NGS-based workflows for biopharmaceutical R&D and manufacturing.