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.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44GM058354-02
Application #
6071810
Study Section
Special Emphasis Panel (ZRG1-SSS-6 (01))
Program Officer
Edmonds, Charles G
Project Start
1998-09-30
Project End
2002-02-28
Budget Start
2000-03-01
Budget End
2001-02-28
Support Year
2
Fiscal Year
2000
Total Cost
$375,812
Indirect Cost
Name
Zirchrom Separations, Inc.
Department
Type
DUNS #
963744867
City
Anoka
State
MN
Country
United States
Zip Code
55303
Sarkar, Sabyasachi; Carr, Peter W; McNeff, Clayton V et al. (2003) Characterization and optimization of a chromatographic process based on ethylenediamine-N,N,N',N'-tetra(methylphosphonic) acid-modified zirconia particles. J Chromatogr B Analyt Technol Biomed Life Sci 790:143-52
Subramanian, Anuradha; Sarkar, Sabyasachi (2002) Use of a modified zirconia support in the separation of immunoproteins. J Chromatogr A 944:179-87