PRODUCTION OF PREPARATIVE ZIRCONIA BY SPRAY DRYING

喷雾干燥法制备制备氧化锆

• 批准号: 6363291
• 负责人: CLAYTON VINCENT MCNEFF
• 金额: $ 37.31万
• 依托单位: ZIRCHROM SEPARATIONS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2002-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6363291
• 关键词: adsorption; analytical chemistry; analytical method; chelating agents; chemical synthesis; ethylenediamines; evaporation; liquid chromatography; microcapsule; monoclonal antibody; phase change; physical state; protein purification; technology /technique development; zirconium

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.

所提出的第II阶段研究的目标是通过喷雾干燥扩大新型多孔氧化锆微球的制造，用于生物分子的大规模制备液相色谱。 第二阶段的重点将是在生产成本方面优化15-30微米平均直径多孔氧化锆的制造，以及生产第二类100-200微米颗粒。此外，这些氧化锆颗粒将用乙二胺-N，N '-四（甲基膦酸）（EDTPA）涂覆，以产生用于纯化蛋白质的生物相容性固定相。包被的氧化锆颗粒将被填充到制备液相色谱柱中，并用于大规模纯化单克隆抗体。 这些柱将在成本、使用的复杂性和最终产品的质量方面与目前使用的大规模纯化抗体的方法进行比较。在第二阶段，它将被证明，超稳定的制备氧化锆柱可以作为一个具有成本效益的替代目前使用的方法。 该项目将与明尼苏达大学密切合作进行。 该项目的主要好处将是开发具有成本效益的抗体纯化技术，从而使纯抗体更容易用于医学研究和临床测试。拟议的商业应用：48亿美元的生物技术产业中约有20%集中在治疗性蛋白质上。 治疗生物技术的一个主要新兴组成部分是单克隆抗体，可用于癌症和HIV治疗等领域的临床分析和研究。 本研究将提供一种新型的超稳定的制备液相色谱相，用于纯化生物医药产品，如单克隆抗体。

项目成果

Characterization and optimization of a chromatographic process based on ethylenediamine-N,N,N',N'-tetra(methylphosphonic) acid-modified zirconia particles.

基于乙二胺-N,N,N,N-四(甲基膦酸)酸改性氧化锆颗粒的色谱工艺的表征和优化。

• DOI: 10.1016/s1570-0232(03)00126-0
• 发表时间: 2003
• 期刊: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
• 作者: Sarkar,Sabyasachi;Carr,PeterW;McNeff,ClaytonV;Subramanian,Anu
• 通讯作者: Subramanian,Anu