Advancing cell therapy manufacturing

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.

This application shows that the Applied Biosystems™ SteriSEQ™ Kit is a rapid qPCR test for detecting bacteria and fungi in cell therapy products, delivering results in 5 hours. It supports in-process testing and traditional methods, ensuring timely release of therapies with short shelf lives by identifying the 6 species in USP <71> and other relevant microbes.