Utilization of risk-based approach to characterize starting material for autologous CAR-T manufacturing

Chimeric antigen (CAR) T cell therapy is a cell-based, personalized cancer immunotherapy. It takes advantage of the cytotoxic potential of T lymphocytes to kill tumor cells in an antigen dependent manner. This therapy has proven to be an effective therapy against certain hematologic malignancies. As with other biologic products, efforts to optimize the manufacturing process can help ensure the safety and efficacy of the product. Cell based products are far more complex than any other active pharmaceutical ingredients, therefore it is even more critical that sponsors understand the impact of the starting material (apheresis cells) for the manufacturing process. The industry is learning about health authority expectations in the last few years, with the commercialization of two CAR-T products, Kymriah™ and Yescarta™. Demonstrating an understanding of the starting material, including its impact on manufacturing and the means to control its impact where needed, is one way sponsors can respond to the expectations. In this article, the reader will find the application of a risk-based approach to identify both the key attributes of starting material that can impact CAR-T product manufacturing and the means to control for those attributes.

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