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International and Asian Regulatory Perspectives
Manufacturing and Process Development Strategies – Solutions for Efficient Scale Up and Scale Out
Expansion of T cells was a critical step for preparing chimeric antigen receptor (CAR) T cells for therapy. Although serum was widely applied in the culture or expansion of T cells, the quality of serum could be varied from batch to batch, leading to the variation of T cell expansion and quality. In addition, the safety of pathogens from serum was required to be considered. To overcome the disadvantages of serum application in T cell culture, serum-free and xeno-free culture conditions were required. Here, we developed a rapid serum-free culture condition for the expansion of immune T cells ex vivo. Human T cells were isolated from the PBMCs of healthy donor using a density gradient medium followed by CD3+ magnetic cell separation. The isolated CD3+ T cells were applied into serum-free medium supplied with IL-2. After a 2-week culture, T cells could expand more than 100-3,000 folds, and the cell viability in all samples was above 90%. The T cell pollutions could be controlled at averagely about 40% of CD8+ T cells and averagely about 55% of CD4+ T cells after culture. These conditions could be applied in the expansion of CAR T cells for cell therapy to support the minimum requirement of blood or cell samples from patients.
Production Considerations – Facilities linked to manufacturing strategies
Informa is looking for 5 speakers to join this panel discussion looking at the below topics:
Logistics, Supply Chain, and Cryopreservation Techniques