摘要
目的考察一次性储液袋材质的耐受性、冻存原液的病毒活力和工艺可操作性,确认一次性储液袋用于腮腺炎病毒原液冻存工艺的可行性。方法使用两种品牌(TH和AB)的一次性储液袋和1 L玻璃瓶各冻存3批腮腺炎病毒原液,并对冻存原液开展稳定性研究。结果使用TH、AB品牌一次性储液袋冻存的原液置-20℃以下保存,至15个月病毒滴度平均下降幅度分别为0.10和0.13 lgCCID50/ml,两者间差异无统计学意义,预估稳定期均大于15个月,远超现有原液有效期;用1 L玻璃瓶冻存3批原液在同等条件保存,至15个月病毒滴度平均下降幅度为0.17 lgCCID50/ml。两种工艺冻存的病毒滴度均符合标准(6.1~7.5 lgCCID50/ml),且差异无统计学意义。结论一次性储液袋可替代现有1 L玻璃瓶用于腮腺炎病毒原液的冻存,在无菌性、有效性等方面更贴合腮腺炎减毒活疫苗的生产要求。
Objective To confirm the feasibility of using disposable storage bags for mumps virus stock freezing by investigating the resistance of the material,virus viability of the stock freezing and the process operability.Methods Three batches of mumps virus stock were frozen using two brands(TH and AB)of disposable storage bags and 1 L glass bottles.Stability studies were conducted on the frozen stock solution.Results The mean virus titer decrease up to 15 months for the stock solutions frozen in TH and AB brands disposable storage bags(below-20℃)were 0.10 and 0.13 lgCCID50/ml,respectively,with no statistically significant difference.The estimated stable period was more than 15 months,far exceeding the validity period of the existing stock solution.The mean virus titer decrease up to 15 months for the stock solutions frozen in 1 L glass bottles was 0.17 lgCCID50/ml under same conditions.The virus titer of the test and control groups both met the standard of 6.1-7.5 lgCCID50/ml,and there was no statistically significant difference between the bag and bottle groups.Conclusion Disposable storage bags can be used to replace the existing 1 L glass bottles for the freezing and storage of mumps virus stock solution,and are more suitable for the production requirments of live attenuated mumps vaccine in terms of sterility and efficacy.
作者
沈谊清
杨文震
陈哲文
周锋
丁文正
张芹
汪张建
许晚
闻捷
陈晓望
Shen Yiqing;Yang Wenzhen;Chen Zhewen;Zhou Feng;Ding Wenzheng;Zhang Qin;Wang Zhangjian;Xu Wan;Wen Jie;Chen Xiaowang(Vaccine DivisionⅡ,Shanghai Institute of Biological Products Co.,Ltd.,Shanghai 201403,China;Shanghai Institute of Biological Products Co.,Ltd.,Shanghai 201403,China)
出处
《国际生物制品学杂志》
CAS
2022年第3期154-158,共5页
International Journal of Biologicals
基金
国家科技重大专项(2018ZX09738003-005)。
关键词
腮腺炎病毒原液
一次性储液袋
稳定性研究
Mumps virus stock solution
Disposable storage bag
Stability study
