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

用于细胞疗法和生物制药产品无菌检测的新型诊断平台

• 批准号: 10913207
• 负责人: Anna Lau
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10913207
• 关键词: Adopted; Algorithms; Awareness; Biochemical; Biological Assay; Biological Products; Cell Therapy; Clinical; Clinical Microbiology; Comparative Study; Cyclic GMP; Databases; Dental; Detection; Dialysis procedure; Ensure; Environmental Monitoring; Event; Goals; Hematopoietic stem cells; Industry; Infusion procedures; Instruction; Laboratories; Learning; Marketing; Methods; Molecular; Multicenter Studies; Mycoplasma; Organism; Paper; Patients; Performance; Pharmaceutical Preparations; Pharmacy facility; Proteomics; Publishing; Regulation; Safety; Streptococcus bovis; Testing; Tumor-Infiltrating Lymphocytes; United States National Institutes of Health; Variant; clinically relevant; detection limit; diagnostic platform; falls; improved; novel diagnostics; novel therapeutics; sterility testing; water testing

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.

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。该研究对于强调使用10种对照标准品的平台与在肿瘤浸润淋巴细胞存在下进行测试的平台之间的试验覆盖率和检测限的惊人变化非常重要。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。

项目成果

Sterility Testing for Hematopoietic Stem Cells.

造血干细胞的无菌测试。

• DOI: 10.1128/jcm.01654-22
• 发表时间: 2023
• 期刊: Journal of clinical microbiology
• 影响因子: 9.4
• 作者: Cundell,Tony;Atkins,JWade;Lau,AnnaF
• 通讯作者: Lau,AnnaF

Problematic Dichotomization of Risk for Intensive Care Unit (ICU)-Acquired Invasive Candidiasis: Results Using a Risk-Predictive Model to Categorize 3 Levels of Risk From a Multicenter Prospective Cohort of Australian ICU Patients.

重症监护病房 (ICU) 获得性侵袭性念珠菌病风险的问题二分法：使用风险预测模型对澳大利亚 ICU 患者多中心前瞻性队列进行 3 级风险分类的结果。

• DOI: 10.1093/cid/ciw610
• 发表时间: 2016
• 期刊: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
• 作者: Playford,EGeoffrey;Lipman,Jeffrey;Jones,Michael;Lau,AnnaF;Kabir,Masrura;Chen,SharonC-A;Marriott,DeborahJ;Seppelt,Ian;Gottlieb,Thomas;Cheung,Winston;Iredell,JonathanR;McBryde,EmmaS;Sorrell,TaniaC
• 通讯作者: Sorrell,TaniaC

Performance of the MSI-2 Database for Fungal Identification by Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry from Cleanroom Environments.

MSI-2 数据库在洁净室环境中通过基质辅助激光解吸电离飞行时间质谱法识别真菌的性能。

• DOI: 10.1128/jcm.01353-22
• 发表时间: 2023
• 期刊: Journal of clinical microbiology
• 影响因子: 9.4
• 作者: Trivitt,GloriaE;Lau,AnnaF
• 通讯作者: Lau,AnnaF

Pooled Saliva Specimens for SARS-CoV-2 Testing.

• DOI: 10.1128/jcm.02486-20
• 发表时间: 2021-02-18
• 期刊: Journal of clinical microbiology
• 影响因子: 9.4
• 作者: Barat B;Das S;De Giorgi V;Henderson DK;Kopka S;Lau AF;Miller T;Moriarty T;Palmore TN;Sawney S;Spalding C;Tanjutco P;Wortmann G;Zelazny AM;Frank KM
• 通讯作者: Frank KM

Matrix-Assisted Laser Desorption Ionization Time-of-Flight for Fungal Identification.

• DOI: 10.1016/j.cll.2021.03.006
• 发表时间: 2021-06
• 期刊: Clinics in laboratory medicine
• 影响因子: 1.7
• 作者: Lau AF