Establishment of a Vaccine Pilot Plant

疫苗试验工厂（VPP）是一个多用途设施，旨在根据美国食品和药物管理局（FDA）要求的现行良好生产规范（cgmp）生产用于人体临床试验的疫苗。该设施包括一个接收原材料的仓库、生产缓冲液和培养基成分的中央工艺支持设施、生产活性疫苗成分的生产套房、将产品灌装到小瓶中以交付给诊所的灌装套房、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的配套办公室和实用空间。这些领域都协同工作，将原材料转化为可在人体中进行评估的疫苗产品。该设施的开发于2005年完成，并于2006年1月开始临床生产。候选艾滋病毒、埃博拉、马尔堡和H5N1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 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 ingredients, 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.