Rapid Mycoplasma Testing With BIOFIRE®

Mycoplasma testing is a critical requirement in the manufacturing of cell-based therapies, ensuring product safety before release to patients. Traditional culture-based methods remain the regulatory gold standard, but their long turnaround times—often up to 28 days—can delay critical treatment timelines.

To address these limitations, rapid PCR-based testing approaches have been developed to accelerate detection while maintaining high sensitivity and regulatory alignment. These modern methods integrate automated workflows within closed systems, reducing manual intervention, minimizing contamination risk, and improving consistency of results.

Such technologies are particularly valuable for therapies with accelerated release requirements, such as autologous cell treatments, where speed is essential. Rapid testing can also support multiple stages of manufacturing, including raw material screening, in-process monitoring, and final product release.

By combining speed, sensitivity, and automation, these approaches help streamline workflows and enhance the reliability of safety testing in advanced therapeutic production.