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

在本财政年度，我们发表了一项关于五种不同支原体分子检测试剂性能的大规模比较研究，这些检测试剂已上市用于细胞治疗放行。这项研究对于强调使用10种对照标准品的平台与在肿瘤浸润淋巴细胞存在的情况下进行测试之间的检测覆盖范围和检测限的惊人差异非常重要。我们还发表了关于MSI-2数据库用于真菌鉴定的cGMP和环境应用的文章，并显示当MSI-2，Bruker和NIH数据库相结合时，性能有所改善。以前的研究仅显示MSI-2的临床影响。另一项比较生化、测序和蛋白质组学平台性能的大规模、多中心研究是针对S。牛群识别和划分。因为S.牛组与潜在的临床意义有关，我们的结果有助于指导实验室测试算法，进一步的物种特异性鉴定（超出组指定）是临床上需要的。我们还发表了一篇小型综述，总结了造血干细胞的无菌检测需求，强调了监管要求、检测要求和临床相关性。最后，我们发布了一个教学视频和方法文件，这将有助于任何实验室带来cGMP测试实践。该视频和论文涵盖了一般洁净室实践、更衣要求、环境监测实践和无菌测试方法。

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.