Equivalency of PCR-Based Rapid Sterility Testing and the Compendial Culture Method According to Ph. Eur. 2.6.1., JP 4.06 and USP <71> Application Note

Sterility testing is a critical component of the release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients. The current compendial sterility test for most bacteria takes 14 days and 28 days for mycoplasma testing before contami­nation can be ruled out with certainty 1,2,3. However, time-to result is an important attribute of testing for short shelf-life cellular therapeutics, especially for autologous cell thera­pies intended to for terminally ill patients.

As a result, growth-independent rapid assays are in increas­ing demand. To fulfill this demand, we developed and com­prehensively validated a highly sensitive and broad range microbial detection system, consisting of an efficient Mi­crosart^® ATMP Extraction DNA isolation protocol, and fol­lowed by a real-time PCR assay using the Microsart^® ATMP Bacteria/Fungi/Mycoplasma kit.

In this study, we compared the microbial detection capability of the Microsart^® ATMP Bacteria and Microsart^® ATMP Fungi Real-time PCR kits with the compendial sterility test.