Minaris Advanced Therapies, LLC announced an expanded 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. The team at Minaris successfully qualified the BIOFIRE system for use in GMP manufacturing by using a study design built to withstand regulatory scrutiny and reflect real-world cell and gene therapy production.

A broad range of representative sample matrices, from in-process cell culture media to final drug products, were spiked with live, viable mycoplasma strains to rigorously assess detection performance under conditions that closely mirror real-world manufacturing scenarios. Compared to more limited qualifications, this comprehensive approach provides stronger scientific justification, greater assurance of assay robustness, and a data package well positioned to meet regulatory expectations. 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. In addition to rapid detection, Minaris' contained laboratory enables live mycoplasma spikes to support product-specific qualifications 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.

With this expanded capability, Minaris Advanced Testing now offers three methods for mycoplasma detection to support different program needs and timelines: Rapid PCR mycoplasma testing using BIOFIRE Mycoplasma from bioMérieux, Mycoplasma DNA Detection by MycoSEQ Plus from Thermo Fisher, Traditional compendial (EP/JP/USP) culture-based mycoplasma detection (GMP). 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. BIOFIRE rapid PCR mycoplasma testing and associated product-specific qualification support are now available through Minaris Advanced Testing.