Sterility testing is vital for cell therapy product release due to the potentially lethal effects of microbial contamination. Traditional sterility tests for most bacteria take 14 days and 28 days for mycoplasma, which is problematic for short shelf-life cellular therapeutics. Consequently, there's a growing demand for rapid, growth-independent assays.

To meet this need, Sartorius developed a microbial detection system, which includes an efficient Microsart^® ATMP Extraction DNA isolation protocol and a real-time PCR assay using the Microsart^® ATMP Bacteria/Fungi kit. This system was validated to evaluate its bacterial and fungal detection capability, in line with the European Pharmacopeia chapter 5.1.6 requirements.

Our study shows that PCR assays are comparable to the compendial culture method in detecting microbial contaminants. For comparison, spiked samples were tested in parallel at an external contract lab, according to Ph. Eur. 2.6.1, JP 4.06, and USP <71>.

Download Application Note