Minaris Expands Rapid Mycoplasma Detection Services With bioMérieux's BIOFIRE® Platform To Reduce Turnaround Time For Release And In-Process Testing

Minaris Advanced Testing now offers an additional rapid PCR mycoplasma testing method to support accelerated lot release for advanced therapies and reduce overall development and manufacturing timelines.

Philadelphia, PA — Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and multimodality biosafety testing provider, today 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 (3) 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.

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; additional details are available in the recently published whitepaper, “Speeding Up Safety: An Evaluation of bioMérieux’s BIOFIRE^®️ Mycoplasma Technology”

About Minaris Advanced Testing

Minaris Advanced Testing provides multimodality biosafety testing services for cell and gene therapies and biologics, including viral clearance, biosafety testing, product characterization, and GMP analytics to support programs from development through commercial readiness. With a client-first approach, Minaris Advanced Testing delivers efficient, cost-effective testing solutions and a streamlined experience that makes it easier for sponsors to execute studies and advance their programs.

About Minaris

Minaris is a global cell and gene therapy (CGT) CDMO and multimodal biosafety testing organization. With more than 25 years of CGT development and manufacturing expertise and more than 40 years in biosafety testing, Minaris combines deep legacy experience with state-of-the-art GMP facilities as a fully U.S.-owned organization under new ownership and management, built for today’s evolving therapeutic landscape.

Through its divisions, Minaris Advanced Therapies and Minaris Advanced Testing, the company supports innovators from IND through commercial supply and delivers GMP analytics, biosafety, viral clearance, and product characterization across CGT and biologics. With five global sites across three continents, Minaris is committed to helping partners bring more therapies to more patients worldwide. For more information, visit minaris.com or follow us on LinkedIn.