STRATEGY FOR VALIDATION OF NEW MYCOPLASMA NUCLEIC ACID DETECTION CLOSED SYSTEM AND IT USE IN ROUTINE BIOPHARMACEUTICAL MANUFACTURING.

Mollicutes class (e.g. mycoplasma species) are notorious bacterial contaminants in eukaryotic cell cultures, known for being particularly difficult to detect and eliminate. Their presence can negatively impact the health of cultured cells, decrease bioreactor yields, interfere with in vitro tests and, in some cases, cause disease. Accordingly, mycoplasma testing represents a common bottleneck in the manufacturing process for which compendial mycoplasma tests may not be suitable due to their lengthy turnaround times. This is even more true, in the case of short shelf-life products, that requires short turnaround time for manufacturing. To address the need for more rapid test methods, pharmacopoeias have provided guidance on the use of mycoplasma Nucleic Acid Amplification Techniques (NATs) as an alternative to compendial methods for lot release testing and in-process testing. In this article, we summarize the discussion of a group of pharmaceutical experts who met to propose recommendations and a path forward for the method validation and method suitability testing of a new mycoplasma nucleic acid-based test, the BIOFIRE® Mycoplasma Test. In contrast to conventional NATs, which require a significant amount of hands-on time from highly skilled operators, BIOFIRE® Mycoplasma test provides a closed and fully automated "lab in a pouch" NAT system. This innovative solution offers minimal hands-on time, minimal user training and skill, and delivers the results in about one hour. This paper offers a summary of the different working sessions held outlining key recommendations for validating the BIOFIRE® Mycoplasma test for release of commercial drug products.