Establishment of a Vaccine Pilot Plant

疫苗中试工厂（VPP）是一个多用途设施，旨在根据美国食品药品监督管理局（FDA）要求的现行药品生产质量管理规范（cGMP）生产用于人体临床试验的疫苗和治疗产品。 该设施由接收原材料的仓库、生产缓冲液和培养基组分的中央工艺支持设施、生产活性疫苗和治疗产品的生产车间、将产品灌装至小瓶中以交付给诊所的灌装车间、检测疫苗产品的质量控制实验室以及工作人员和设备的支持性办公室和公用设施空间组成。 这些领域都协同工作，将原材料转化为可以在人体中进行评估的疫苗产品。 该设施的开发于2005年完成，临床生产于2006年1月开始。 艾滋病毒、埃博拉、马尔堡和H5N1及大流行性流感候选疫苗的临床试验材料已经完成。

The Vaccine Pilot Plant (VPP) is a multiuse facility designed to manufacture vaccines and therapeutic products for human clinical trials according to current Good Manufacturing Practices (cGMPs) required by the US Food and Drug Administration (FDA). The facility is composed of a warehouse to receive the raw materials, central process support facility to manufacture buffers and media components, manufacturing suites to produce active vaccine and therapeutic products, a filling suite to fill the product into vials for delivery to the clinic, Quality Control laboratories to test the vaccine product, and supporting office and utility space for staff and equipment. These areas all work in concert to take raw materials and turn them into vaccine product that can be evaluated in humans. Development of the facility was completed in 2005 and clinical manufacturing started in January 2006. Clinical trial materials for candidate HIV, Ebola, Marburg and H5N1 and pandemic Influenza vaccines have been completed.