Mycoplasma Testing: Rapid Detection Accelerates Biopharmaceutical Release

Traditional culture-based mycoplasma testing requires a 28-day incubation period, creating a critical bottleneck for short-shelf-life cell therapies and rapid-release biologics. With contamination rates affecting up to 35% of cell cultures, the risk of chromosomal abnormalities and total batch loss remains a constant threat to manufacturing yields and facility uptime.

This article examines the transition toward rapid nucleic acid amplification technologies (NAT) to mitigate these operational risks. It details the performance of qPCR-based detection kits—validated by Eurofins—which achieve a sensitivity of 10 CFU/mL, meeting stringent EP 2.6.7 and USP regulatory standards. Covering over 250 species of Mollicutes, this methodology provides a robust, high-specificity alternative to time-intensive traditional assays.

Access the full article to learn how to integrate high-sensitivity rapid testing into your quality control workflow, significantly reducing release timelines while ensuring patient safety and process integrity.