Establishment and operation of a Vaccine Pilot Plant

VRC/NIAID疫苗中试工厂是一个多用途设施，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、生物制剂和佐剂。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、生产活性疫苗和生物制品的生产车间、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，以制造可以在人体中进行评估的临床试验材料。该设施的开发于2005年完成，临床生产于2006年1月开始。已准备好HIV候选疫苗和单克隆抗体（mAb）、埃博拉疫苗、马尔堡疫苗、基孔古亚疫苗、H5 N1/大流行性流感疫苗、通用流感疫苗、呼吸道合胞病毒疫苗、疟疾单克隆抗体和寨卡疫苗的临床试验材料。正在进行的生产活动包括佐剂、HIV亚单位和肽缀合物疫苗、下一代HIV mAb、通用流感多组分蛋白纳米颗粒疫苗和下一代抗疟疾单克隆抗体。

The VRC/NIAID vaccine pilot plant is a multiuse facility designed to manufacture vaccines, biologicals, and adjuvants for human clinical trials according to current Good Manufacturing Practices (cGMP) 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 biologics 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 manufacture clinical trial materials 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 vaccines and monoclonal antibodies (mAb), Ebola vaccines, Marburg vaccines, Chikunguya vaccines, H5N1/ pandemic Influenza vaccines, universal influenza vaccines, Respiratory syncytial virus vaccines, Malaria monoclonal antibodies, and Zika vaccines have been prepared. Ongoing manufacturing campaigns include an adjuvant, HIV subunit and peptide-conjugate vaccines, next-generation HIV mAbs, universal influenza multi-component protein nanoparticle vaccines, and next-generation monoclonal antibodies against Malaria.