SciELO - Scientific Electronic Library Online

vol.31 issue11Purification and binding analysis of the nitrogen fixation regulatory NifA protein from Azospirillum brasilensePurification of human albumin by the combination of the method of Cohn with liquid chromatography author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand




Related links


Brazilian Journal of Medical and Biological Research

Print version ISSN 0100-879XOn-line version ISSN 1414-431X


TANAKA, K. et al. A chromatographic method for the production of a human immunoglobulin G solution for intravenous use. Braz J Med Biol Res [online]. 1998, vol.31, n.11, pp.1375-1381. ISSN 0100-879X.

Immunoglobulin G (IgG) of excellent quality for intravenous use was obtained from the cryosupernatant of human plasma by a chromatographic method based on a mixture of ion-exchange, DEAE-Sepharose FF and arginine Sepharose 4B affinity chromatography and a final purification step by Sephacryl S-300 HR gel filtration. The yield of 10 experimental batches produced was 3.5 g IgG per liter of plasma. A solvent/detergent combination of 1% Tri (n-butyl) phosphate and 1% Triton X-100 was used to inactivate lipid-coated viruses. Analysis of the final product (5% liquid IgG) based on the mean for 10 batches showed 94% monomers, 5.5% dimers and 0.5% polymers and aggregates. Anticomplementary activity was 0.3 CH50/mg IgG and prekallikrein activator levels were less than 5 IU/ml. Stability at 37oC for 30 days in the liquid state was satisfactory. IgG was stored in flasks (2.5 g/flask) at 4 to 8oC. All the characteristics of the product were consistent with the requirements of the 1997 Pharmacopée Européenne.

Keywords : immunoglobulin G production; hemoderivate production; intravenous gamma globulin production; industrial chromatography; downstream process.

        · text in English     · English ( pdf epdf )


Creative Commons License All the contents of this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License