工艺研发

一次性储液袋冻存腮腺炎病毒原液的稳定性研究

  • 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
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  • 1上海生物制品研究所有限责任公司疫苗二室,上海2014032上海生物制品研究所有限责任公司,上海201403

网络出版日期: 2025-08-16

基金资助

国家科技重大专项(2018ZX09738003-005

Stability of mumps virus stock solution frozen in disposable storage bag

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  • 1Vaccine Division , Shanghai Institute of Biological Products Co., Ltd., Shanghai 201403, China; 2Shanghai Institute of Biological Products Co., Ltd., Shanghai 201403, China

Online published: 2025-08-16

Supported by

National Science and Technology Major Project (2018ZX09738003-005) 

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THAB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,对冻存原液开展稳定性研究。结果  使用THAB品牌一次性储液袋冻存的原液置-20 ℃以下保存15个月病毒滴度平均下降幅度分别为0.100.13 lgCCID50/ml,两者差异无统计学意义,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,15个月病毒滴度平均下降幅度为0.17 lgCCID50/ml。两种工艺冻存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。

本文引用格式

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 . 一次性储液袋冻存腮腺炎病毒原液的稳定性研究[J]. 国际生物制品学杂志, 2022 , 45(3) : 154 -158 . DOI: 10.3760/cma.j.cn 311962-20210915-00052

Abstract

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 frozen in TH and AB brands disposable storage bagsbelow -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.

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