Quality Control in Cell & Gene Therapy: Defining CQAs & Regulatory Strategy
Автор: Charles River Labs
Загружено: 2025-10-22
Просмотров: 21
Описание:
Quality control and assurance are essential to successful cell and gene therapy development. In this expert panel from the 2023 CGT Summit hosted by Charles River Laboratories, leaders from ARM, Charles River, and Advanced Cell & Gene Therapy LLC discuss critical quality control strategies, including potency assays, starting material testing, and analytical bottlenecks. The conversation highlights the importance of defining critical quality attributes (CQAs), working with CDMOs, and aligning with FDA guidance to ensure compliance and scalability. Learn how to future-proof your QC approach in a rapidly evolving regulatory landscape.
https://bit.ly/42ScPCZ
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