细胞工厂自动化操作系统在水痘疫苗生产中的应用  

Application of ACFM in varicella vaccine production

作　　者：马相虎[1] 沈谊清[1] 杨月莲[1] 周锋[1] 谢蕾[1] 树志龙 周翎乔[1] 王亮[1] 

机构地区：[1]上海生物制品研究所有限责任公司,上海200051

出　　处：《中国新药杂志》2014年第20期2446-2449,共4页Chinese Journal of New Drugs

基　　金：2011上海市引进技术的吸收与创新年度计划(11XI-17)

摘　　要：目的:应用细胞工厂自动化操作系统生产水痘疫苗,从而提高水痘疫苗产量,减少批间差异性。方法:采用细胞工厂及细胞工厂自动化操作系统进行水痘疫苗的传代制备,与人工操作细胞工厂进行传代制备作对照,比较两种操作方式的细胞生长情况、操作时间等,并对制备的原液进行各项检定。结果:在同样细胞复苏量的情况下,采用自动化操作系统比人工操作生产的水痘疫苗产量要高,批间差异小,操作时间短,且各项检测指标均合格。结论:利用细胞工厂自动化操作系统制备水痘疫苗,提高了疫苗批间均一性,降低人工劳动强度,缩短操作时间,可用于水痘疫苗的大规模生产。Objective： To apply cell factory automation operating system in chickenpox vaccine production,thereby to improve varicella vaccine production and reduce the difference between batches. Methods： Passages were prepared in the cell factory using automation operating system. Manually operated cell factories were used as the control. Two types of operation modes were applied to measure cell production,operating time,and the verification of liquid preparation. Results： In the same condition of cell recovery,the varicella vaccine production by automated system was higher than by manual operation system. Also,batch difference was low,operation time was short,and all the indexes were qualified in the production by automated system. Conclusion： The cell factory automation operating system used for preparation of varicella vaccine not only improves the vaccine batch uniformity,but also reduces labor intensity and shortens the operation time. Thus this system can be used for mass production of varicella vaccine.

关 键 词：细胞工厂自动化操作系统 水痘疫苗 细胞工厂 

分 类 号：R373.2[医药卫生—病原生物学]