Minaris Adds BIOFIRE for Faster Mycoplasma Detection

Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and multimodality biosafety testing provider, has expanded its rapid mycoplasma testing capability within its Minaris Advanced Testing division through the implementation of bioMérieux’s BIOFIRE Mycoplasma platform.

The expanded capability is designed to significantly reduce turnaround time for mycoplasma detection for advanced therapies.

BIOFIRE Mycoplasma is a closed, automated multiplex PCR system that delivers sample-to-answer results with minimal hands-on time. The single-use pouch format reduces operator handling and touchpoints, limiting opportunities for human error and improving reproducibility and traceability.  By combining rapid molecular technology with a rigorously qualified, GMP-aligned workflow, Minaris is now able to deliver a Certificate of Analysis (CoA) for mycoplasma detection in as little as three days using the BIOFIRE system—helping reduce batch release delays, streamline manufacturing timelines, and support faster delivery of cell and gene therapies to patients.

“Speed is paramount in mycoplasma detection, especially for advanced therapies where manufacturing timelines are tight” said Joe Newcome, Senior Director Analytical Development. “By adding BIOFIRE Mycoplasma to our service portfolio and pairing it with product-specific qualification support, we’re helping clients shorten decision timelines, reduce operational risk, and maintain high data integrity expectations. This launch reflects our broader goal of reducing overall development and manufacturing timelines, including ‘vein-to-vein’ considerations for cell therapies, by offering faster, reliable biosafety testing pathways.”

In addition to rapid detection, Minaris’ contained laboratory enables live mycoplasma spikes to support product-specific qualifications (PSQ) under realistic contamination conditions, an approach that is more representative of true contamination scenarios than controls based on DNA alone, as it validates the entire detection workflow end-to-end.

This expanded capability builds on Minaris’ years of experience with both PCR- and culture-based compendial mycoplasma testing, supported by access to additional laboratories for troubleshooting and identification if a positive result is detected.