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用于降低成本的脊髓灰质炎灭活疫苗(sIPV)工艺开发。

sIPV process development for costs reduction.

作者信息

Thomassen Yvonne E, Bakker Wilfried A M

机构信息

Institute for Translational Vaccinology, PO Box 450, 3720 AL Bilthoven, The Netherlands.

Institute for Translational Vaccinology, PO Box 450, 3720 AL Bilthoven, The Netherlands.

出版信息

Vaccine. 2015 Aug 20;33(35):4307-12. doi: 10.1016/j.vaccine.2015.03.076. Epub 2015 Apr 6.

Abstract

Polio is expected to be eradicated within only a few years from now. Upon polio eradication, the use of oral polio vaccines, which can cause circulating and virulent vaccine derived polio viruses, will be stopped. From this moment onwards, inactivated polio vaccines (IPV) will be used for worldwide vaccination against polio. An increased demand for IPV is thus anticipated. As a result, process development studies regarding the IPV production process, developed in the 1960s, have intensified. Studies on yield optimization aiming at costs reduction as well as the use of alternative polio viruses, which are more biosafe for manufacturing, are actual. Here our strategy to setup a new IPV production process using attenuated Sabin polio virus strains is presented. Moreover, aspects on reduction of the costs of goods and the impact of process optimization on sIPV costs are reviewed.

摘要

预计在短短几年内就能根除脊髓灰质炎。脊髓灰质炎根除后,将停止使用可能导致循环性和毒性疫苗衍生脊髓灰质炎病毒的口服脊髓灰质炎疫苗。从现在起,将使用灭活脊髓灰质炎疫苗(IPV)在全球范围内进行脊髓灰质炎疫苗接种。因此,预计对IPV的需求将会增加。结果,针对20世纪60年代开发的IPV生产工艺的工艺开发研究得到了加强。旨在降低成本以及使用对生产更具生物安全性的替代脊髓灰质炎病毒的产量优化研究正在进行。本文介绍了我们使用减毒的萨宾脊髓灰质炎病毒株建立新的IPV生产工艺的策略。此外,还综述了降低商品成本以及工艺优化对sIPV成本的影响等方面。

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