PRODUCTION OF PREPARATIVE ZIRCONIA BY SPRAY DRYING

这项研究的目标是制造一种新的 多孔氧化锆微球，通过喷雾干燥，用于大规模 生物分子的制备液相色谱。具体来说， 将评估新材料经济净化的能力 克隆抗体 在研究的第一阶段， 将开发喷雾干燥方法以产生平均15-30微米的 用作制备液体的直径多孔氧化锆 色谱基质。 在本研究的第二阶段， 制备氧化锆颗粒将用乙二胺-N涂覆， N -四（甲基膦酸）（EDTPA），以产生生物相容性 用于蛋白质纯化的固定相。 这些柱子将 然后用于评估成本效益的可行性，一步到位 大规模纯化单克隆抗体。 这项研究将 集中精力利用固有的化学稳定性， 氧化锆和实验将做证明清洁性 制备的EDTPA改性氧化锆的可再生性 化学侵蚀性条件。 该项目将在 与分包商明尼苏达大学密切合作。 该项目的主要好处将是成本的发展 有效的抗体纯化技术，从而使纯 抗体更容易用于医学研究和临床 试验. 拟定商业应用： 在48亿美元的生物技术投资中， 工业集中于治疗性蛋白质。 一个主要的新兴组成部分 单克隆抗体是治疗生物技术的一个重要方面， 用于癌症和HIV等领域的临床检测和研究 治疗。 这项研究将提供一类新的超稳定的 制备型液相色谱固定相 生物医药产品如单克隆抗体的纯化 抗体的

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.