A Successful Journey to Cell Therapy Manufacturing: From R&D to Lot-Release

Presented by

Kasey Kime, Sean Chang, Uma Lakshmipathy

About this talk

Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to attack cancer cells, but manufacturing these cells represents a major challenge for the industry. Although every therapy and process are different, there are a few key decisions that are critical to the success of any advanced therapy medicinal product (ATMP) and for the success of the company that plans to bring them to the clinic. In this webinar, we will discuss three key areas to consider when you’re preparing to commercialize a cell therapy: starting/raw material, controlled manufacturing process, and testing safety & quality. You'll learn about regulatory requirements for GMP ancillary materials for cell and gene therapy, closed-system manufacturing and how it can improve overall productivity and product safety, and characterization and lot release testing, proper validation for regulatory CMC filing.

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