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| Preparation of Human SARS Immunoglobulin for Intravenous Injection |
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Abstract Objective To produce the SARS immunoglobulin for intravenous injection from convalescent plasma. Methods Combination of the protein purification process of cold ethanol with ion exchange chromatography.Treat the source plasma with S/D，incubate the bulk at low pH and filtrate the bulk with nanofilter. Results The purity of the product was 99.0%,the monomer and dimmer contents of IgG was 100%,the ACA was 11%,the PKA wasn’t detected,the sterlity,safety,pyrogen and stability tests met the Chinese Requirements of Biological Products. the product was specific to SARS antigen and the titers of the product was1:83(ELISA),1:1600(IFA) and 1:200(NT)。Conclusion The process was feasible, the product had high titer SARS-antibody and the quality of product met the standard of Intravenous Injection.
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Received: 20 February 2006
Published: 15 June 2006
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