Automated Mycoplasma Detection in Cell and Gene Therapies

This technical report discusses the automated nucleic acid amplification assay developed for mycoplasma detection in cell and gene therapy products. The report outlines the importance of microbiological testing for advanced therapeutic medicinal products, particularly for ensuring patient safety prior to infusion. It details the limitations of traditional compendial microbiological assays, which require extensive time and resources, and presents the BIOFIRE® MYCOPLASMA test as a rapid alternative. The test can detect over 130 species of mycoplasma in approximately one hour, significantly reducing the time to obtain results. The report also describes two sample preparation protocols that align with regulatory guidelines, allowing for effective testing in various scenarios. The findings indicate that the BIOFIRE® FILMARRAY® 2.0 Industry system is suitable for use as a release test, demonstrating high sensitivity and reliability across different cell types. The report concludes with an emphasis on the system's ability to streamline mycoplasma testing processes in the cell and gene therapy market.