Production Core

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Since traditional methods of producing biopharmaceuticals can provide neither the cost structure nor the capacity to address the large volume of low cost biopharmaceuticals required for protection against sexually transtmitted infections, alternate manufacturing platforms, such as plants, are being established. The Production Core will be responsible for production of plant made reagents to support the three research projects; these reagents include both monoclonal antibodies and subunit vaccines. The production core will be staffed by personnel with extensive prior experience in plant biotechnology, and will draw upon available reserves of "DNA toolbox elements" such as expression vectors, DNA regulatory sequences, genes encoding selectable markers, and other materials utilized by our research teams over the last 10+ years of research on plant made biopharmaceuticals. A particularily important component of the performance sites noted below are access to USDA approved Biosafety level 2 (BL-2) greenhouses and personnel who have conducted approved field tests of pharmaceutical producing plants. The Core will utilize different plant expression systems to meet two key needs: first, a rapid production of recombinant proteins to evaluate their properties in preclinical studies; and second, robust and cost-effective plant production systems that can be easily increased to provide large-scale supply. In addition, the Core will develop the purification protocols for monoclonal antibodies to be used in clinical trials, and define plant processing protocols to be used for mucosal immunization using the plant-derived antigens. In total, the Core will be responsible for production of cloned MAbs to support Project 1, production of vaccinogens for Project 2, and GMP production of MAbs and vaccinogens for the clinical trials proposed in Project 3.