ウェビナー動画：Astellas Institute for Regenerative Medicine（AIRM）社、ヒト細胞製品の製造における安全性向上

AIRM社の細胞遺伝子学グループでは、新たな規制要件に対応するNGSワークフローを開発しています。本動画では、同社のCytogenomics Associate Directorが登壇し、細胞療法のバイオセーフティー試験のためのGMP環境下におけるNGSアッセイの導入について紹介しています。

In this webinar, Tracie Fradet, Associate Director of Cytogenomics at the Astellas Institute for Regenerative Medicine (AIRM), discusses the implementation of NGS assays to ensure the biosafety of cell therapy products in a validated environment. Tracie outlines the effort of the Cytogenomics group in developing a GMP-compliant NGS workflow to comply with the evolving regulatory requirements. She emphasizes the value of Genedata Selector in facilitating the integration, analysis, and sharing of project-related data in a GMP environment, thereby improving decision-making and accelerating time to market. Tracie concludes her talk by sharing insights from the recent FDA Type D meeting held at AIRM, where the FDA expressed their alignment with AIRM’s NGS platform and validation approach.

This talk was given as part of our regular Open Forum events on NGS-based QC for advancing drug development and manufacturing. 

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.