Quality Considerations for Establishing a GMP-Compliant NGS Method

In this webinar, Tracie Fradet, Associate Director, Cytogenomics, Astellas Institute for Regenerative Medicine (AIRM) reflects on the motivation of the Cytogenomics Group at AIRM to establish in-house expertise for the evaluation of the genetic stability of cell banks and drug substances through the implementation of NGS, especially in a validated environment. The primary goal of implementing NGS in biosafety testing is to replace traditional in vitro and in vivo assays, which are typically outsourced and quite limited. Tracie describes the virtuous collaboration with Genedata Selector, likening it to a jigsaw puzzle where the pieces fell into place perfectly, all in a matter of months from start to finish. She praises the platform’s ability to integrate, analyze, and share project-related data in a GMP environment for improved decision-making and speed to market.

This talk was given as part of our regular Open Forums on NGS-based QC for advancing drug development and manufacturing, hosted by Genedata Selector^®. 

Who should watch? 

Biopharma and biotech professionals looking to advance analytical development, biosafety, and QC testing for CGT products by embracing digitalization and innovative enterprise data analysis systems.