人用疫苗生产用细胞基质安全性评估现状  

Status of safety assessment of cell substrate for production of vaccines for human use

作　　者：王美皓 刘文凯(综述) 乔自林[1] 王家敏(审校)[1] WANG Mei-hao;LIU Wen-kai;QIAO Zi-lin;WANG Jia-min(Biomedical Research Center,Northwest Minzu University,Gansu Tech Innovation Center of Animal Cell,Lanzhou 730030,Gansu Province,China)

机构地区：[1]西北民族大学生物医学研究中心甘肃省动物细胞技术创新中心,甘肃兰州730030 [2]西北民族大学生命科学与工程学院,甘肃兰州730030

出　　处：《中国生物制品学杂志》2021年第3期362-366,371,共6页Chinese Journal of Biologicals

基　　金：国家科技重大专项重大新药创制项目(2015ZX09102016);甘肃省重点研发计划(18YF1FA121);中央高校基本科研业务费专项资金(31920190004,31920200069);教育部动物医学生物工程创新团队(IRT-17R88)。

摘　　要：疫苗接种是保护机体免受疫病侵害的一种有效的防御机制。随着科技的进步以及疫苗需求量的日益上升,疫苗生产商通过不断探索,在疫苗生产工艺的上游融合细胞培养技术,利用细胞基质对病毒性疫苗进行大规模的生产。面对监管部门颁布的严格的安全生产条令,如何对细胞基质进行安全性评估已经成为疫苗生产商必须考虑的重点。本文将着重介绍疫苗生产用细胞基质的相关安全性问题,旨在为生产新型病毒性疫苗提供细胞基质安全性方面的相关参考。Vaccination is an effective defense mechanism to protect the body from epidemic diseases. With the progress of science and technology and the increasing needs for vaccines,the manufacturers through apply cell substrate to the large-scale production of viral vaccines by fusing the cell culture technology upstream to the vaccine production process based on continuous exploration. Facing the strict safety regulations issued by the regulatory authorities,how to evaluate the safety of the cell substrate has become the focus which should be considered by the vaccine manufacturers. This article introduces the safety issues of cell substrate used for vaccine production in order to provide a reference for the production of novel viral vaccines.

关 键 词：疫苗 生产工艺 细胞基质 生物反应器 

分 类 号：R392-33[医药卫生—免疫学]