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 compendial sterility test takes 14 days before contamination can be ruled out with certainty, which is too long for short shelf-life cellular therapeutics and especially for autologous cell therapies intended to treat terminally ill patients.
As a result, there is an increasing demand for growth-independent rapid assays. Therefore, a detection system consisting of the highly efficient DNA extraction protocol Microsart® ATMP Extraction followed by the real time PCR assay Microsart® ATMP Bacteria | Fungi (or the combination product Microsart® ATMP Sterile Release) has been developed.
In this webinar we present a validation study that was designed to evaluate the bacterial and fungal detection capability. The study was set up to fulfill the EP 5.1.6. and USP <1223> as well as the guidance chapter <1071>.
Presenter: Dr. Kai Nesemann, Sartorius Lab Instruments
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