Sterility is a critical quality attribute (CQA) of cellular therapeutics. Since microbial contamination of cell therapy products can potentially result in the deaths of the recipients, sterility testing is a critical component of the release testing for any cell therapy product. The current sterility test takes 14 days before contamination can be ruled out with certainty. This period is too long for short shelf life cellular therapeutics and particularly for autologous cell therapies intended to treat terminally ill patients. As a result, there is an increasing demand for growth-independent rapid assays. 
A detection system consisting of the highly efficient DNA extraction protocol Microsart® Bacteria Extraction followed by the real-time PCR assay Microsart® ATMP Bacteria has therefore been developed.

A validation study was designed to evaluate the kit’s bacterial detection capability. The study was set up to meet requirements of the European Pharmacopeia chapter 5.1.6 and is available here as a free download.

Learn more about Sartorius solutions for microbiology quality control at www.sartorius.com/microbio-qc