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Vaccine Production Program

Phillip L. Gomez III, Ph.D., M.B.A.

Phillip Gomez III 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.

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Last updated 01.30.04 (ks)

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