Critical Quality Metrics in Cell Sample Prep for Cell & Gene Therapy Bioanalytics

In this panel discussion, Virginia Litwin, Ph.D. (CRL), Christoph Eberle, MICR, FRSPH (CRL), Mahwish Natalia, MA, Ph.D. (Takeda Oncology), and Melvin Lye, MBA (Curiox Biosystems) discuss the role of partnerships between early- and late-stream analytical assay developers. While tackling unique challenges in validating flow cytometric methods for Chimeric Antigen Receptor (CAR) T cells, during manufacturing and clinical monitoring. Additionally, evolving targets during transferability and scalability also need to be addressed through Control-Design modalities like increasing automation and integration of various processes.

They will also be introducing Critical Quality Attributes and key considerations when designing sample preparation methods, optimization, validation, and implementation for cell and gene therapy bioanalytics.

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