细胞制剂支原体检测方法概述

Overview of detection methods for Mycoplasma in cell preparations

支原体是细胞培养过程中常见的外源性污染物。支原体污染的检测方法较多,但由于活细胞制剂终产品不能进行灭菌处理,且目前的支原体检测方法培养法和指示细胞培养法(DNA染色法)所需时间较长,在活细胞制剂终产品的快速放行检测中有一定的局限性,因而需要更完善的细胞制剂终产品的支原体检测方法。文章对支原体的形态学、培养法和核酸检测法进行简要介绍,以期为开展细胞制剂质量监测技术评价体系建设提供参考。

Mycoplasma is a common exogenous contaminant during cell culturing.There are many detection methods for Mycoplasma contamination.However,due to the fact that the final product of living cell preparations can not be sterilized,the detection method of Mycoplasma is culturing and indicator cell culturing(DNA staining method),and the detection time is long.The rapid release test of the final cell preparation has certain limitation,so it is necessary to improve the Mycoplasma detection methods for the final cell preparation.This review briefly introduces the morphology,culturing and nucleic acid detection method of Mycoplasma,hoping to provide a reference for the construction of the evaluation system of cell preparation quality monitoring technology.