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