工艺研发

四价流感疫苗病毒纯化方法

  • Luo Dan ,
  • Liu Peng ,
  • Liu Chunyou ,
  • Liu Zitao ,
  • Liu Li ,
  • Bai Yaofei
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  • 1深圳康泰生物制品股份有限公司研发二室,深圳 518107;2深圳康泰生物制品股份有限公司研发检定室,深圳 518107

网络出版日期: 2025-08-16

Virus purification method for quadrivalent influenza vaccine

  • 罗丹 刘鹏 刘春游 刘子韬 刘丽 白要飞
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  • 1 R&D Division , Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen 518107, China; 2 R&D Test Laboratory, Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen 518107, China

Online published: 2025-08-16

摘要

目的  建立采用国产填料纯化四价流感疫苗病毒的生产工艺。 方法  分别使用进口填料Sepharose 4FF 和国产填料Seplife 4FF,对多价流感疫苗进行纯化。对纯化后的病毒液经过单向免疫扩散检测、ELISA、电子显微镜(电镜)观察,综合评估分离纯化效果。 结果 在50 cm/h流速时,Seplife 4FF对血凝素的回收率高于Sepharose 4FF,卵清蛋白的去除率相当,4个型别流感病毒的卵清蛋白去除率和血凝素回收率的95%置信区间分别为91.5%~94.6%和92.4%~100.8%,两种填料纯化的电镜观察结果一致。 结论  成功建立了用国产填料高效纯化流感病毒的方法。

本文引用格式

Luo Dan , Liu Peng , Liu Chunyou , Liu Zitao , Liu Li , Bai Yaofei . 四价流感疫苗病毒纯化方法[J]. 国际生物制品学杂志, 2022 , 45(2) : 107 -110 . DOI: 10.3760/cma.j.cn 311962-20210729-00044

Abstract

Objective  To establish a production process for purifying virus in quadrivalent influenza vaccine using domestic fillers. Methods  Imported filler Sepharose 4FF and domestic filler Seplife 4FF were used to purify the multivalent influenza vaccine, respectively. The purified virus liquid underwent comprehensive evaluation of the separation and purification effect through single radial immunodiffusion assay, ELISA and electron microscope observation. Results  The recovery rate of hemagglutinin by Seplife 4FF was higher than that of Sepharose 4FF and removal rates of ovalbumin were similar at 50 cm/h flow rate. The 95% confidence intervals of removal rate for ovalbumin and recovery rate for hemagglutinin of Seplife 4FF for the four types of viruses were 91.5%-94.6% and 92.4%-100.8%, respectiely, with consistent results of electron microscope observation for both fillers. Conclusion  A method using domestical filler to efficiently purify influenza virus has been successfully established.

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