PRODUCTION OF PREPARATIVE ZIRCONIA BY SPRAY DRYING

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The goal of the proposed phase II research is to scale-up the manufacture of a new class of porous zirconia micro-spheres, by spray drying, for large- scale preparative liquid chromatography of biomolecules. The focus of phase II will be to optimize the manufacture of 15-30 micron average diameter porous zirconia in terms of cost of production, as well as produce a second class of 100-200 micron particles. Further, these 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. The coated zirconia particles will be packed into preparative liquid chromatographic columns and used for the large-scale purification of monoclonal antibodies. These columns will be compared to currently used large scale methods of purifying antibodies in terms of cost, complexity of use and quality of final product. In phase II it will be demonstrated that ultra-stable preparative zirconia columns can be used as a cost-effective alternative to currently used methods. This project will be conducted in close collaboration with the University of Minnesota. 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 APPLICATIONS: Approximately 20% of the $4.8 billion 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 phase useful for the purification of bio-pharmaceutical products such as monoclonal antibodies.