Raw Material Sourcing and Qualification

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Presented by

Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC

About this talk

Effective raw materials sourcing, testing, qualification and control are critical for product safety and quality to assure lot-to-lot consistency and functional activity in the manufacturing process. This is more challenging for biological raw materials, such as enzymes, sera, and cytokines, which often cannot be fully defined by testing, and may present risks related to animal or human source, or country of origin. These points can be addressed by sourcing and qualifying materials based on an evaluation of potential risk and desired functional characteristics, and defining supplier requirements, testing, specifications, and other control mechanisms accordingly. Raw material qualification becomes increasingly rigorous and comprehensive as clinical development progresses. This webinar will identify critical concerns, clarify regulatory requirements and outline how to develop robust systems for managing and qualifying raw materials.

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