By Thermofisher Scientific / Applied Biosystems

Published in: Outsourced Pharma

Published on: May 14, 2024

In recent years, cell therapy products have shown tremendous potential in regenerative medicine and the treatment of various diseases. These products are often derived through complex processes involving the isolation of human cells, particularly the expansion and manipulation of chimeric antigen receptor (CAR) T cells, which renders them vulnerable to microbial contamination. Therefore, ensuring the sterility of cell therapy products is crucial to guaranteeing product quality and safety. The traditional sterility testing method, as outlined by USP chapter , is a compendial method that relies on microbial growth–based detection. This method requires a 14-day culture, which can create difficulties in promptly releasing cell therapy products that may have a limited shelf life or require immediate administration to patients.

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