Novel Diagnostic Platforms for Sterility Testing of Cellular Therapies and Biopharmaceutical Products

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During this fiscal year, we published a large-scale comparative study on the performance of five different Mycoplasma molecular assays marketed for cellular therapy release. This study was important in highlighting the surprising variation in assay coverage and limit of detection between the platforms using 10 control standards and testing in the presence of tumor-infiltrating lymphocytes. We also published on the cGMP and environmental applications of the MSI-2 database for fungal identification and showed improved performance when the MSI-2, Bruker, and NIH databases were combined. Previous studies had only shown clinical impact of the MSI-2. Another large-scale, multi-center study comparing the performance of biochemical, sequencing, and proteomic platforms was performed for S. bovis group identification and delineation. Because certain organisms within the S. bovis group are associated with underlying clinical implications, our results help guide laboratories in testing algorithms further species specific identification (beyond the group designation) is clinically warranted. We also published a mini-review summarizing the sterility testing needs for hematopoietic stem cells highlighting regulatory requirements, testing requirements, and clinical relevance. Lastly, we published an instructional video and methods paper which will be instrumental for any laboratory bringing on cGMP testing practices. This video and paper covered general cleanroom practices, gowning requirements, environmental monitoring practices, and sterility testing methods.