Data/hora: 06/06/2024 05:24:12

Provedor de dados: 	56	
País: 	Brazil	
Título: 	A chromatographic method for the production of a human immunoglobulin G solution for intravenous use	
Autores: 	Tanaka,K.; Sawatani,E.; Shigueoka,E.M.; Campos,T.C.X.B.; Nakao,H.C.; Dias,G.A.; Fujita,R.K.; Arashiro,F.	
Data: 	1998-11-01	
Ano: 	1998	
Palavras-chave: 	Immunoglobulin G production; Hemoderivate production; Intravenous gamma globulin production; Industrial chromatography; Downstream process.	
Resumo: 	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.	
Tipo: 	Info:eu-repo/semantics/article	
Idioma: 	Inglês	
Identificador: 	http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X1998001100002	
Editor: 	Associação Brasileira de Divulgação Científica	
Relação: 	10.1590/S0100-879X1998001100002	
Formato: 	text/html	
Fonte: 	Brazilian Journal of Medical and Biological Research  v.31 n.11 1998	
Fonte: 	info:eu-repo/semantics/openAccess