传代细胞制备流感病毒疫苗工艺探究进展.pdfVIP

2009, 43( 6): 43~ 48/, # 43# 1 1 2 吕宏亮, 付秀花, 郑 明 ( 1. , 100081; 2. , 100081) [] 2009- 05- 05 [] A [] 1002- 1280( 2009) 06- 0043- 06 [] S859. 797 [ ] 目前人及动物用流行性感冒病毒疫苗(流感疫苗)的生产大多采用鸡 这种传统的 方法劳动强度大, 鸡 用量大, 需要繁琐的纯化工艺去除鸡 蛋白减少过敏反应, 流感的大流行 性以及新发流感的流行迫切需要一种新的疫苗生产方法: 用哺乳动物细胞生产疫苗细胞生产 流感疫苗经过研究和发展, 从可用于生产的VeroMDCKPE - C6细胞的生物学鉴定分析到流 感病毒的重配适用培养以及下游工艺的悬浮培养浓缩纯化安全以及效果观察都取得长足 进展本文从细胞流感疫苗的细胞基质病毒适用重配培养浓缩纯化及其疫苗的安全效果 观察方面综述了细胞流感疫苗的研发重点 [] 传代细胞; 流感疫苗; 研究进展 Advance in CellDerived Influenza V irus Vaccine Process Developm ent 1 1 2 LU Hong- liang, FU Xiu- hua, ZHENG M ing ( 1. Q ianyuanhao B iolog ica l Co. , L td, B eij ing 100081; 2. Ch ina I nstitu te of Ve terina ry D rug Con trol, Be ji ing 100081; Ch ina ) Abstract: This article discussed themammalian cell line used to grow influenza virus adapted cultivation, aswell as downstream process development, suspension cultivation, concentration, purification for influenza vaccines. Influenza viruses for production were presently produced in embryonated hen. s eggs. This conventional standard methodologywas extremely cumbersome; it required m illions of eggs and an extensive purification to reduce the amount of contam inating egg proteins and to m inmi ise the risk of allergies against egg album in. The shortage of eggs in a pandem ic situation, the selection of egg- adapted variants and the presence of adventitious viruses has emphasised the necessity for production of influenza vaccines on awell characterised stablemammalian cell line. M ammalian cell- derived vaccine