Easy 1-Hour Mycoplasma Detection in Cell Therapy Samples
The data summarized in this white paper is from two cell therapy manufacturers that evaluated the BIOFIRE® FILMARRAY® 2.0 System and presented their results at the 2022 Association for the Advancement of Blood and Biotherapies (AABB) Annual Conference. Samples were evaluated with up to three 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 is presented.
The results of these studies by independent evaluators show that the BIOFIRE FILMARRAY 2.0 System is well suited as both a release test or as an in-process control test for cell therapy samples that may contain high concentrations of mammalian cells. The results showed no product interference and high sensitivity providing reliable mycoplasma results in less than 1 hour.
Download the full white paper for a summary of the data and to learn how you can enable rapid, easy mycoplasma testing in-house.