PRODUCTION OF PREPARATIVE ZIRCONIA BY SPRAY DRYING

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The goal of the proposed research is to manufacture a new class of porous zirconia micro-spheres, by spray drying, for large-scale preparative liquid chromatography of bio-molecules. Specifically this new material will be evaluated for its ability to economically purify monoclonal antibodies. In the first stage of the research optimized spray drying methods will be developed to produce 15-30 micron average diameter porous zirconia to be used as a preparative liquid chromatographic substrate. In the second stage of this research the preparative zirconia particles will be coated with ethylenediamine-N, N -tetra(methylphosphonic) acid (EDTPA) to produce a bio-compatible stationary phase for the purification of proteins. These columns will then be used to assess the feasibility of doing cost-effective, one-step large-scale purification of monoclonal antibodies. The research will focus its efforts taking advantage of the inherent chemical stability of zirconia and experiments will be done to demonstrate the cleanability and regenerability of preparative EDTPA-modified zirconia under chemically aggressive conditions. This project will be conducted in close collaboration with the University of Minnesota, a sub-contractor. The primary benefit of this project will be the development of cost effective antibody purification technology, thereby making pure antibodies more readily available for medical research and clinical testing. PROPOSED COMMERCIAL APPLICATION: Approximately 20 percent of the 4.8 billion dollars biotechnology industry is focused on therapeutic proteins. A major emerging component of therapeutic biotechnology is the monoclonal antibody which is useful for clinical assays and research in areas such as cancer and HIV treatments. This research will provide a novel class of ultra-stable preparative liquid chromatographic stationary phases useful for the purification of bio-pharmaceutical products such as monoclonal antibodies.