The Vaccine Production Program at the VRC is
responsible for the manufacture and regulatory submission of VRC
vaccines for clinical trials. The VPP is dedicated to the development
of manufacturing processes that will provide material for clinical
trials as well as a solid foundation for the eventual manufacture
of vaccines at large scale. This program utilizes existing laboratory
facilities at the VRC and contract agreements to manufacture vaccines
with industrial partners and at a cGMP Vaccine Pilot Plant.
The VRC laboratories, located in Bethesda,
MD, include cell banking, fermentation, cell culture, purification,
and quality control areas. Process development in these laboratories
focuses on the production of novel adenoviral and DNA based vaccines.
The laboratories develop the techniques for the construction of
adenoviral packaging cell lines, the design and optimization of
cell culture systems, the development of effective methods of
purification, and strategies for final vaccine formulation. The
assay develop lab develops appropriate characterization and in-process
assays to monitor production quality.
The laboratory currently has Collaborative
Research and Development Agreements (CRADAs) with multiple partners
for the further development of VRC vaccines against HIV, Ebola,
West Nile Virus, and SARS. CRADA partners include Vical, GenVec,
Crucell, and Ichor.
In addition, a contractor leased and operated
GMP pilot plant is being planned for the production of HIV vaccines
for Phase I/II human trials. This SAIC-Frederick facility will
perform the scale-up and final development of selected manufacturing
processes. Quality Control labs, as well as a Quality Assurance
organization, will also support pilot plant production.
Manufacture of clinical materials has commenced,
with multiple organizations providing materials to the VRC, under
NIH contracts, for development and clinical production. These
contract mechanisms help expedite the Vaccine Production program
delivery of novel vaccine candidate for clinical evaluation.