Knowledge Transfer and Partnerships (KTP) Vaccinology, National Institute of Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands.
Vaccine. 2011 Jul 1;29 Suppl 1:A8-11. doi: 10.1016/j.vaccine.2011.04.124.
Since 2008, the World Health Organization has provided seed grants to 11 manufacturers in low- and middle-income countries to establish or improve their pandemic influenza vaccine production capacity. To facilitate this ambitious project, an influenza vaccine technology platform (or "hub") was established at the Netherlands Vaccine Institute for training and technology transfer to developing countries. During its first two years of operation, a robust and transferable monovalent pilot process for egg-based inactivated whole virus influenza A vaccine production was established under international Good Manufacturing Practice standards, as well as in-process and release assays. A course curriculum was designed, including a two-volume practical handbook on production and quality control. Four generic hands-on training courses were successfully realized for over 40 employees from 15 developing country manufacturers. Planned extensions to the curriculum include cell-culture based technology for viral vaccine production, split virion influenza production, and generic adjuvant formulation. We conclude that technology transfer through the hub model works well, significantly builds vaccine manufacturing capacity in developing countries, and thereby increases global and equitable access to vaccines of high public health relevance.
自 2008 年以来，世界卫生组织已向 11 家中低收入国家的制造商提供种子资金，以建立或提高其大流行性流感疫苗生产能力。为了推动这一雄心勃勃的项目，在荷兰疫苗研究所建立了一个流感疫苗技术平台（或“中心”），以培训和向发展中国家转让技术。在头两年的运作中，根据国际良好生产规范标准以及过程中和放行检测，建立了用于生产基于鸡蛋的灭活全病毒流感 A 疫苗的稳健且可转让的单价试验性工艺。还设计了课程大纲，包括关于生产和质量控制的两卷实用手册。已成功为来自 15 个发展中国家制造商的 40 多名员工举办了 4 次通用实践培训课程。课程大纲的计划扩展包括用于病毒疫苗生产的细胞培养技术、分裂病毒体流感生产和通用佐剂配方。我们的结论是，通过中心模式进行技术转让效果良好，可大大增强发展中国家的疫苗生产能力，从而增加与高度公共卫生相关性的疫苗在全球和公平获得。
