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10 L转瓶培养与10层细胞工厂培养制备麻疹单次病毒收获液的比较
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Abstract:
目的:对10 L转瓶培养与10层细胞工厂培养制备麻疹单次病毒收获液进行比较,评价两种生产工艺的优劣。方法:将10 L转瓶培养与10层细胞工厂培养制备麻疹单次病毒收获液的每一步进行比较,通过关键质量指标的病毒滴度来对其生产工艺进行评价。结果:10 L转瓶培养和10层细胞工厂培养制备麻疹单次病毒收获液的病毒滴度分别为5.6 lgCCID50/mL、5.6 lgCCID50/mL。结论:10 L转瓶培养工艺和10层细胞工厂培养工艺均可以制备麻疹单次病毒收获液,二者没有显著性差异。
Objective: The objective is to compare the advantages and shortages between 10 L spinner bottle cell culture and 10 layer cell factory cell culture in preparing measles virus single harvest fluid process. Methods: In each step, the two processes were assessed by viral titer, a Critical Quality Attribute (CQA) in measles virus harvest production. Results: The viral titer results of 10 L spinner bottle cell culture process and 10 layer cell factory cell culture process are 5.6 lgCCID50/mL and 5.6 lgCCID50/mL respectively. Conclusion: The measles virus single harvest fluid could be prepared by both spinner bottle cell culture and 10 layer cell factory cell culture, but there was no significant difference between them.
[1] | 徐文青, 陈列胜, 朵煜涛, 等. 麻疹疫苗转瓶培养多次收液生产工艺的探索[J]. 中国生物制品学杂志, 1997, 10(1): 35-37. |
[2] | 闫磊, 李海燕, 赵海波, 等. 麻疹减毒活疫苗细胞工厂多次收获工艺探索[J]. 国际生物制品学杂志, 2021, 44(2): 79-82. |
[3] | 国家药典委员会. 中华人民共和国药典2020年版三部[M]. 北京: 中国医药科技出版社, 2020: 171. |
[4] | 周妍, 王云霞, 仲宇航, 等. 细胞工厂制备冻干甲型肝炎减毒活疫苗的研究[J]. 预防医学论坛, 2012, 18(8): 595-597. |
[5] | 王亮, 杨月莲, 周锋, 等. 细胞工厂在水痘疫苗生产中的应用[J]. 中国新药杂志, 2012, 21(10): 1178-1181. |