Poster: Next Generation Cellular Therapeutic Technologies — Rapid Detection of Bacterial Contamination
Sterility testing is a critical component of the release testing for any cell therapy product. The current compendial sterility test takes 14 days before contamination can be ruled out with certainty, which is too long for short shelf life cellular therapeutics.
There is an increasing demand for growth-independent rapid assays. To meet this demand, 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 been developed. A validation study meeting the requirements of the European Pharmacopeia chapter 5.1.6 has been executed to evaluate the kit’s bacterial detection capability.