PBF is offering bacterial and viral purified protein production as well as live or killed vaccines. Aseptic filling , including live virus and bacteria,up to 2000 vials. Liquid, adjuvenated and lyophilization capability
Mission: To be a prepared and fully functional cGMP manufacturing facility at all times in order to aid Army researchers in the development of vaccines for the war fighter. To achieve the mission of being ready and fully trained, the WRAIR PBF must continually develop and maintain projects and working relationships with other government entities (NIH, USAID, etc.) through Interagency Agreements and with universities and commercial companies and other private organizations through Cooperative Research and Development Agreements (CRADAs). Capabilities: Serving various clients and principal investigators, the WRAIR PBF can provide Phase1 and Phase 2 cGMP bacterial and viral vaccine constructs/production as follows: 1) Live, attenuated, killed or purified protein based vaccines; 2) Master and production seed/cell banking; 3) Fermentation (to 300 liters); 4) Protein purification; 5) Viral purification; 6) Aseptic filling of final vaccine material (validated to 2000 vials); 7) Lyophilization of final or bulk material; 8) Various types of vaccine product testing; 9) Specialized viral testing; 10) Stability program administration and testing for manufactured products. Major Accomplishments: 1)19 years of continual GMP manufacturing; 2) Worked with over 50 different clients/organizations; 3) Four products initiated at the PBF reaching licensure; 4) Pristine record of aseptic filling validation; 5)Type V Facility Master File filed and maintained at the FDA; 6) Excellent record of flexible and supportive service and interactions with clients; 7) Continual implementation of Validation Master Plan Fully developed GMP documentation system.
PBF does not work with organisms above BSL-2 level; each potential production of vaccine or therapeutic must be discussed to determine compatibility with capabilities.