Establishment and operation of a Vaccine Pilot Plant

疫苗试验工厂（VPP）又称疫苗临床材料计划（VCMP）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和治疗产品。该设施由一个接收原材料的仓库、一个制造缓冲液和介质组件的中央工艺支持设施、一个生产活疫苗和治疗产品的生产套件、一个将产品灌装成小瓶以交付给诊所的灌装套件、一个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组成。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。HIV、埃博拉、马尔堡、基孔古雅热、H5N1/大流行性流感疫苗、通用流感疫苗、呼吸道合胞病毒疫苗和寨卡病毒候选疫苗的临床试验材料已准备就绪。

The Vaccine Pilot Plant (VPP) a.k.a. Vaccine Clinical Materials Program (VCMP) 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, Chikunguya, H5N1/ pandemic Influenza vaccines, universal influenza vaccines, Respiratory syncytial virus vaccines and Zika have been prepared.