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

在本财年，我们发表了一项大规模的比较研究，对用于细胞治疗释放的五种不同支原体分子分析的性能进行了比较。这项研究对于强调在使用10个对照标准的平台和在肿瘤浸润性淋巴细胞存在的检测之间的检测覆盖率和检测极限方面的惊人差异具有重要意义。我们还发表了用于真菌鉴定的MSI-2数据库的cGMP和环境应用，并显示出当MSI-2、Bruker和NIH数据库组合时性能有所改善。之前的研究只显示了MSI-2的临床影响。另一项大规模、多中心的研究比较了生化平台、测序平台和蛋白质组平台的性能，用于鉴定和描绘牛链球菌群体。由于牛链球菌群中的某些生物与潜在的临床意义相关，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识别(超越群的指定)在临床上是必要的。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，我们发布了一份教学视频和方法论文，这将对任何实验室进行cGMP测试实践都很有帮助。本视频和论文涵盖了一般洁净室操作规范、工作服要求、环境监控操作规范和无菌测试方法。

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.