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.
| Rao, Srinivas S; Gomez, Phillip; Mascola, John R et al. (2006) Comparative evaluation of three different intramuscular delivery methods for DNA immunization in a nonhuman primate animal model. Vaccine 24:367-73 |
