Merck, West Point, PA 19486; and
The Maurice R. Hilleman Center for Vaccine Manufacturing, Merck, Durham, NC 27712.
PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):408-422. doi: 10.5731/pdajpst.2019.010975. Epub 2020 Feb 14.
In the aseptic manufacture of parenteral drug products and low bioburden, cell, and gene therapy products, the control and monitoring of environmental- and personnel-associated microorganisms is an imperative for the confirmation of controlled conditions and the assessment of microbial risks. Environmental and personnel monitoring programs exist to assure product quality and serve as one of the several means of removing the emphasis on finished drug product testing. Therefore, these programs must adequately assess these risks and identify situations in which increased microbial risks occur. The major source of microbial risks in the controlled clean room environments for parenteral drug product manufacture are personnel. Modern microbial analytical methods, including metagenomic analysis, have identified a greater abundance of ; traditional culture-based monitoring fails to consistently recover and assist in the identification of the potential risk that this microorganism represents. This review provides a case-study assessment of this microorganism in the context of parenteral manufacture for the purpose of assisting in the deciding the necessary controls and the potential monitoring addressing this microbial risk.
在无菌生产的肠外药物产品和低生物负荷、细胞和基因治疗产品中，对环境和人员相关微生物的控制和监测是确认受控条件和评估微生物风险的必要条件。环境和人员监测方案旨在确保产品质量，并作为去除对成品药物测试的重视的几种手段之一。因此，这些方案必须充分评估这些风险，并确定出现微生物风险增加的情况。在用于肠外药物产品制造的受控洁净室环境中，微生物风险的主要来源是人员。现代微生物分析方法，包括宏基因组分析，已经确定了更多的微生物；传统的基于培养的监测方法无法始终如一地回收并帮助识别该微生物代表的潜在风险。本综述提供了一个关于这种微生物在肠外生产方面的案例研究评估，目的是协助确定必要的控制措施和潜在的监测方法，以解决这种微生物风险。
