Kreeftenberg Hans, van der Velden Tiny, Kersten Gideon, van der Heuvel Nico, de Bruijn Marloes
Netherlands Vaccine Institute (NVI), Antonie van Leeuwenhoeklaan 11, 3720 AL Bilthoven, The Netherlands.
Biologicals. 2006 Jun;34(2):155-8. doi: 10.1016/j.biologicals.2006.02.011. Epub 2006 May 2.
The Netherlands Vaccine Institute (NVI) developed the micro-carrier technology for large-scale production of IPV in the late 1960s and has used this technology successfully to produce IPV as well as DTP-IPV for the national immunization program in the Netherlands. As a public sector organization, and as one of the Millennium Development Goals, NVI has supported over the years access to vaccine technology like DTP and Hib for vaccine manufacturers in developing countries. In line with this role as a resource institute, NVI has recently been approached by a number of vaccine manufacturers, predominantly from developing countries, for transfer of IPV technology to meet the anticipated increase in demand for IPV following OPV cessation. Since WHO encourages new manufacturers to use the attenuated Sabin virus instead of wild polio strains in the production of IPV, NVI decided to respond positively to this WHO policy. The existing NVI experience in large-scale production of IPV and OPV using Vero cell based micro-carrier technology and its experience with experimental Sabin-IPV is an attractive start for the development of Sabin-IPV. This paper discusses the approach followed and the experience already gained in the project, as well as factors critical to its success.
荷兰疫苗研究所（NVI）在20世纪60年代末开发了用于大规模生产脊髓灰质炎灭活疫苗（IPV）的微载体技术，并已成功运用该技术为荷兰国家免疫规划生产IPV以及白百破-IPV。作为一个公共部门组织，并且作为千年发展目标之一，多年来NVI一直支持发展中国家的疫苗制造商获取诸如白百破疫苗和b型流感嗜血杆菌疫苗等疫苗技术。为顺应作为资源机构的这一角色，近期一些主要来自发展中国家的疫苗制造商与NVI接洽，希望转让IPV技术，以满足口服脊髓灰质炎疫苗（OPV）停用后对IPV预期增长的需求。由于世界卫生组织（WHO）鼓励新的制造商在生产IPV时使用减毒的萨宾病毒而非野生脊髓灰质炎病毒株，NVI决定积极响应WHO的这一政策。NVI在使用基于Vero细胞的微载体技术大规模生产IPV和OPV方面的现有经验以及其在实验性萨宾IPV方面的经验，是开发萨宾IPV的一个有吸引力的开端。本文讨论了该项目所采用的方法、已取得的经验以及对其成功至关重要的因素。
