Rapid microbiological testing


The biggest challenge for quality control in the biopharma industry is in reducing the risk of contamination. Microbial contamination of biologic drugs and of cell therapy products threatens patients’ lives.

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. Time-to result is an important attribute in microbial quality control, especially for short shelf-life cellular therapeutics, such us autologous cell therapies which typically have 24 h or less shelf life. As the traditional culture test requires a minimum 4-week incubation to determine if mycoplasma is present, the unprocessed bulk needs to be released into the downstream purification process at manufacturers risk.

To address these challenges, 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 DNA isolation protocol, and followed by a real-time PCR assay using the Microsart® ATMP Bacteria/Fungi/Mycoplasma kit.

Our Microsart® Mycoplasma qPCR detection kits offer a rapid, guideline-compliant solution for mycoplasma detection in cell culture samples.