Testing Cell Therapy Samples for Mycoplasma - 2022 AABB Annual Meeting

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1). Current compendial methods require ≥ 28 days to generate mycoplasma testing results creating delays releasing product. Alternative conventional nucleic acid testing (NAT) methods are available, but these methods often require specialized laboratories, elevated skill levels and significant training to interpret results. The BIOFIRE® Mycoplasma solution utilizes the FILMARRAY® 2.0 Industry instrument and next generation PCR testing where all reagent components are contained in a closed pouch to detect the presence of >130 species of mycoplasma. The system provides sample to answer in ~1 hour with little technical training required providing options for bringing mycoplasma testing directly to the production floor where critical testing is needed.

Present data from two cell therapy manufacturers that evaluated the BIOFIRE® FILMARRAY® 2.0 Industry system with up to 3 compendial mycoplasma strains in the presence of high-density chimeric antigen receptor T (CAR T) cells or autologous cultured chondrocytes. Studies were designed to assess product interference (false-positive rates) and detection (false-negative rates). In addition, data from numerous internal studies that tested product compatibility & low level inoculation on commonly used media and raw materials are presented.