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The success of cell therapy products, including CAR-T cell therapy, is significantly dependent upon the process and material-selection strategies set in the early stages of development. These strategies encompass not only materials in the final approved product, but also the raw materials throughout the production process. To facilitate the translation into clinical trials and beyond, developing a raw material and process strategy that considers the end goal is critical.

·     What to look for when selecting raw materials? ·     What makes a product GMP-grade and why is this important? ·      What does Good Manufacturing Practice (GMP) mean regarding raw or ancillary materials? ·    What is the risk classification for GMP materials and how does this affect my cell therapy product?

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