Establishment and operation of a Vaccine Pilot Plant

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications & trials

Abstract

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.