Minaris has expanded its rapid mycoplasma detection services within Minaris Advanced Testing through the implementation of bioMérieux’s BIOFIRE® Mycoplasma platform, a move aimed at reducing turnaround times for release and in-process testing in cell and gene therapy manufacturing.
The expanded capability allows Minaris to deliver a Certificate of Analysis (CoA) for mycoplasma detection in as little as three days using the BIOFIRE® system, helping cell and gene therapy developers reduce batch release delays, streamline manufacturing timelines, and accelerate delivery of therapies to patients.
For advanced therapy developers, mycoplasma testing can represent a significant operational bottleneck during manufacturing and product release. Rapid and reliable testing methods are increasingly important as developers work to shorten production timelines while maintaining regulatory compliance and product safety.
According to the company, Minaris qualified the BIOFIRE® system for use in GMP manufacturing using representative cell and gene therapy sample matrices and live, viable mycoplasma strains designed to reflect real-world manufacturing conditions. The qualification process included in-process cell culture media and final drug products to assess detection performance under realistic contamination scenarios.
BIOFIRE® Mycoplasma is a closed, automated multiplex PCR platform that provides sample-to-answer results with limited hands-on processing. Its single-use pouch format is designed to reduce operator handling, improve reproducibility, and support traceability in GMP environments.
“Speed is paramount in mycoplasma detection, especially for advanced therapies where manufacturing timelines are tight,” said Joe Newcome, Senior Director of Analytical Development at Minaris. “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.”
Minaris noted that its contained laboratory environment also enables live mycoplasma spike studies for product-specific qualification (PSQ), allowing developers to validate the complete detection workflow under contamination conditions that more closely resemble real manufacturing environments than DNA-only controls.
With the addition of BIOFIRE®, Minaris Advanced Testing now offers three mycoplasma detection approaches to support varying development and manufacturing timelines:
- Rapid PCR mycoplasma testing using BIOFIRE® Mycoplasma from bioMérieux
- Mycoplasma DNA detection using MycoSEQ™ Plus from Thermo Fisher Scientific
- Traditional compendial culture-based mycoplasma detection aligned with EP/JP/USP GMP standards
The expansion builds on Minaris’ existing PCR- and culture-based mycoplasma testing capabilities, along with additional laboratory support for troubleshooting and identification in the event of positive findings.
The company also announced that BIOFIRE® rapid PCR mycoplasma testing and related product-specific qualification support services are now commercially available through Minaris Advanced Testing. Additional technical details are outlined in the company’s recently published whitepaper, “Speeding Up Safety: An Evaluation of bioMérieux’s BIOFIRE®️ Mycoplasma Technology.”
Minaris operates globally as a cell and gene therapy contract development and manufacturing organization (CDMO) and biosafety testing provider, supporting programs from IND through commercial manufacturing across five sites on three continents.
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.
