Validation and Comparability of the BACTEC method & BD FX40 Device for Sterility Testing of CAR-T Drug Products: A Comprehensive Study

Towards Rapid Microbial Testing Methods for the Sterility of CAR-T Drug Products.

The sterility testing of autologous cell therapies, such as CAR-T drug products, is critical to ensuring patient safety and product quality. In this study, SCTbio aimed to validate a rapid microbial method for sterility, using the BD BACTEC FX40 device as an efficient and reliable method allowing rapid sterility testing of frozen CAR-T drug products in just 5 days. SCTbio also sought to demonstrate the method's comparability to the compendial sterility method, 14-day sterility method by direct inoculation (Ph.Eur. Chapter 2.6.1 and USP <71>). Learn more HERE.