- Minaris has expanded its rapid mycoplasma testing capabilities through the implementation of bioMérieux’s BIOFIRE Mycoplasma platform within its Minaris Advanced Testing division.
- The company said the new workflow can deliver a Certificate of Analysis for mycoplasma detection in as little as three days to support cell and gene therapy manufacturing timelines.
Minaris has expanded its rapid mycoplasma testing capabilities for cell and gene therapy manufacturing through the implementation of bioMérieux’s BIOFIRE Mycoplasma platform within its Minaris Advanced Testing division. The company said the expanded capability is designed to reduce turnaround times for mycoplasma detection in advanced therapy manufacturing programs.
According to Minaris, the BIOFIRE system was qualified for use in GMP manufacturing using study designs intended to reflect real-world cell and gene therapy production conditions. The qualification process included testing multiple representative sample matrices, including in-process cell culture media and final drug products, spiked with viable mycoplasma strains to evaluate detection performance under manufacturing-relevant conditions.
Minaris stated that the BIOFIRE Mycoplasma platform is a closed, automated multiplex PCR system that delivers sample-to-answer results with limited operator handling. The company said the single-use pouch format is intended to reduce human error while improving reproducibility and traceability. Using the BIOFIRE workflow, Minaris said it can now provide a Certificate of Analysis for mycoplasma detection in as little as three days.
The expanded service offering includes rapid PCR mycoplasma testing using BIOFIRE Mycoplasma, MycoSEQ Plus DNA detection from Thermo Fisher, and traditional compendial culture-based mycoplasma detection methods. Minaris said the services are supported by additional laboratory capabilities for troubleshooting and identification of positive results.
“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.”
Joe Newcome, Senior Director Analytical Development at Minaris
