Establishment of a Vaccine Pilot Plant

疫苗试验厂(VPP)是一家多用途工厂，旨在根据美国食品和药物管理局(FDA)要求的当前良好制造规范(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、制造缓冲器和介质组件的中央工艺支持设施、生产活性疫苗和治疗产品的制造套件、将产品装入瓶子以便运送到诊所的灌装套件、测试疫苗产品的质量控制实验室以及为工作人员和设备提供支持的办公室和实用空间组成。所有这些领域都协同工作，获取原材料，并将其转化为可在人体上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。候选艾滋病毒、埃博拉、马尔堡和H5N1疫苗以及大流行性流感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.