Establishment and operation of a Vaccine Pilot Plant

VRC/NIAID疫苗试点工厂是一个多用途设施，旨在根据美国食品和药物管理局(FDA)要求的当前良好制造规范(CGMP)生产用于人类临床试验的疫苗、生物制品和佐剂。该设施包括一个接收原材料的仓库，制造缓冲器和介质组件的中央工艺支持设施，生产活性疫苗和生物制品的制造套件，将产品装入瓶子以便交付到诊所的灌装套件，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。这些领域都在协同工作，制造可以在人体上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。已准备好候选艾滋病毒疫苗和单抗、埃博拉疫苗、马尔堡疫苗、基孔古雅疫苗、H5N1/大流行性流感疫苗、通用流感疫苗、呼吸道合胞病毒疫苗、疟疾单抗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、艾滋病毒亚单位和多肽结合疫苗、下一代艾滋病毒单抗、通用流感多组分蛋白纳米颗粒疫苗和下一代抗疟疾单抗。

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.