Automated nucleic acid amplification assay for mycoplasma detection in Cell and Gene therapy products

This content was first published by European Pharmaceutical Review (EPR).

Author: Ambili Menon, PhD, Sr. Staff Scientist, Pharma Quality Control, bioMérieux Inc., Lombard, IL, USA.

Ambili Menon, Pharma Quality Control, bioMérieux Inc. addresses the task of microbiological testing for advanced therapeutic medicinal products.

Cell & Gene therapies (CGT) or advanced therapeutic medicinal products (ATMPs) are innovative medicines developed to treat cancers, rare diseases, autoimmune disorders and injuries. As these therapies utilise living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.

One of these microbiological examinations is the mycoplasma testing of cellular therapy products, which is a regulatory requirement for release. The compendial microbiological assay for mycoplasma testing of biologics, currently recommended by the United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) and the US Food and Drug Administration (FDA), involves the culture of viable mycoplasmas in broth, agar plates and indicator cell cultures. This compendial culture testing utilises complex media and requires ≥ 28 days to generate test results. Waiting 28 days or longer to release product is not a feasible option for most autologous Cell and Gene therapy processes where patients are waiting to be infused and time is critical to effective treatment.

Conventional nucleic acid testing (NAT) methods offer a faster alternative to compendial methods with results often obtained within a single work shift; however, they remain highly manual and require specialised laboratories, elevated skill levels and significant training to execute the test and interpret results. Due to these complexities, mycoplasma testing is often outsourced to third-party laboratories, resulting in additional costs.

BIOFIRE® MYCOPLASMA: bioMérieux provides an innovative test for mycoplasma detection in CGT products. The BIOFIRE® MYCOPLASMA test can detect the presence of >130 species of mycoplasma, providing sample to answer in ~one hour with little technical training required. This provides an easy-to-learn, easy-to-use option to bring mycoplasma testing in-house, saving time and outsourcing costs.

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