Biomolecular Measurement Division, Applied Genetics Group, National Institute of Standards and Technology, Gaithersburg, MD, USA.
Biopharmaceutical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Biologicals. 2022 Oct;80:6-17. doi: 10.1016/j.biologicals.2022.10.002. Epub 2022 Nov 5.
Preventing adventitious agents from contaminating pharmaceutical products has been an important goal of regulatory agencies and industry for decades. Contamination of these products does not only erode consumer trust but also can have potentially serious health consequences. There are a wide variety of adventitious agents that can contaminate many different classifications of products, with each combination requiring different techniques for prevention or detection of adventitious agent contamination. This review seeks to give a brief overview of adventitious agents that have contaminated released pharmaceutical products, explain the different products that are at risk of contamination, then describe the methods commonly used for the prevention and detection of adventitious agent contamination.
防止外来污染物污染药品一直是监管机构和行业数十年来的重要目标。这些产品受到污染不仅会侵蚀消费者的信任，还可能产生严重的健康后果。有许多不同的外来污染物可以污染许多不同分类的产品，每种组合都需要不同的技术来预防或检测外来污染物的污染。本文旨在简要概述污染已放行药品的外来污染物，解释存在污染风险的不同产品，然后描述常用于预防和检测外来污染物污染的方法。
