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A chromatographic method for the production of a human immunoglobulin G solution for intravenous use BJMBR
Tanaka,K.; Sawatani,E.; Shigueoka,E.M.; Campos,T.C.X.B.; Nakao,H.C.; Dias,G.A.; Fujita,R.K.; Arashiro,F..
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...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Immunoglobulin G production; Hemoderivate production; Intravenous gamma globulin production; Industrial chromatography; Downstream process.
Ano: 1998 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X1998001100002
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