重组单抗药物质控中物理检查的有关问题探讨

Discussion on issues related to physical tests in quality control of Mabs

重组单抗药物的物理检查是其质量控制的必要环节,对于评价制品的功能非常重要,对单抗药物安全、有效、质量可控具有重要意义。本文通过阐述物理检查项目中澄清度、浊度、不溶性微粒、澄明度、可见异物和颜色等关键概念及其部分概念表述变化的历史沿革、相似概念的理解和辨析,探讨了中国药典、欧洲药典在上述试验方法的差异,进一步解决了注册检验中物理检查遇到的常见问题,为国内外单抗制品注册检验的相关工作提供参考。

Physical tests of Mabs are essential for the quality control,which are very important for the evaluation of functions, safety, effectiveness, and controllable quality. In this paper, the key concepts such as clarity, turbidity, particulate matter, visible particles and coloration of physical tests were stated. Development of the concepts was also elaborated, as well as similarity and difference in the understanding of the methods between Chinese pharmacopoeia （ChP） and European pharmacopoeia（EP）. Common problems of physical tests for registration were solved further, providing reference for the domestic and foreign registration tests.