Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
9902204 | Journal of Immunological Methods | 2005 | 15 Pages |
Abstract
CIS 00/572, containing CHO cell-derived, glycosylated IFN-β, was clearly shown to be suitable to serve as a primary standard for glycosylated forms of IFN-β, especially clinical grade IFN-β-1a products. It was further shown to exhibit high thermal and long-term stability. Since the CHO cell-derived IFN-β used for preparation of 00/572 was of a greater purity than the IFN-β used for the 2nd IS of IFN-β, Gb23-902-531, it was recommended by the WHO Informal Consultation on the Standardisation of Cytokines, Growth Factors and Other Endocrinological Substances, which met in October 2003, that 00/572 should replace Gb23-902-531 as the IS for glycosylated IFN-β. This recommendation was accepted by the WHO Expert Committee on Biological Standardization (ECBS) at its annual meeting in November 2003 and 00/572 was established as the 3rd IS for human glycosylated IFN-β with an assigned potency of 40,000 IU. As this study identified no advantage to replacing the existing 1st IS for IFN-β Ser 17 mutein, Gxb02-901-535, WHO ECBS accepted that this should continue to serve as the IS for this material.
Keywords
SEAPeCBsNIHVSVSINVEMCVNIAIDHSACISNIBSCIL-6ISREhuman serum albuminSecreted alkaline phosphataseInternational Standardinterferoninterferon stimulated response elementIFNinterleukin-6ChoChinese Hamster OvaryWorld Health OrganizationAntiproliferativeAntiviralNational Institutes of HealthNational Institute for Biological Standards and ControlNational Institute of Allergy and Infectious DiseasesSindbis virusVesicular stomatitis virusEncephalomyocarditis virusReporter geneWHO
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Authors
Anthony Meager, Rose Gaines Das,