A chromatographic method for the production of a human immunoglobulin G solution for intravenous use
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 H...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Associação Brasileira de Divulgação Científica
1998-11-01
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| Series: | Brazilian Journal of Medical and Biological Research |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X1998001100002 |
| _version_ | 1828258836530593792 |
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| author | K. Tanaka E. Sawatani E.M. Shigueoka T.C.X.B. Campos H.C. Nakao G.A. Dias R.K. Fujita F. Arashiro |
| author_facet | K. Tanaka E. Sawatani E.M. Shigueoka T.C.X.B. Campos H.C. Nakao G.A. Dias R.K. Fujita F. Arashiro |
| author_sort | K. Tanaka |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T02:59:24Z |
| format | Article |
| id | doaj.art-0d44d057aa384e788e1c3a41ce207f12 |
| institution | Directory Open Access Journal |
| issn | 0100-879X 1414-431X |
| language | English |
| last_indexed | 2024-04-13T02:59:24Z |
| publishDate | 1998-11-01 |
| publisher | Associação Brasileira de Divulgação Científica |
| record_format | Article |
| series | Brazilian Journal of Medical and Biological Research |
| spelling | doaj.art-0d44d057aa384e788e1c3a41ce207f122022-12-22T03:05:30ZengAssociação Brasileira de Divulgação CientíficaBrazilian Journal of Medical and Biological Research0100-879X1414-431X1998-11-0131111375138110.1590/S0100-879X1998001100002A chromatographic method for the production of a human immunoglobulin G solution for intravenous useK. TanakaE. SawataniE.M. ShigueokaT.C.X.B. CamposH.C. NakaoG.A. DiasR.K. FujitaF. ArashiroImmunoglobulin 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X1998001100002immunoglobulin G productionhemoderivate productionintravenous gamma globulin productionindustrial chromatographydownstream process |
| spellingShingle | K. Tanaka E. Sawatani E.M. Shigueoka T.C.X.B. Campos H.C. Nakao G.A. Dias R.K. Fujita F. Arashiro A chromatographic method for the production of a human immunoglobulin G solution for intravenous use Brazilian Journal of Medical and Biological Research immunoglobulin G production hemoderivate production intravenous gamma globulin production industrial chromatography downstream process |
| title | A chromatographic method for the production of a human immunoglobulin G solution for intravenous use |
| title_full | A chromatographic method for the production of a human immunoglobulin G solution for intravenous use |
| title_fullStr | A chromatographic method for the production of a human immunoglobulin G solution for intravenous use |
| title_full_unstemmed | A chromatographic method for the production of a human immunoglobulin G solution for intravenous use |
| title_short | A chromatographic method for the production of a human immunoglobulin G solution for intravenous use |
| title_sort | chromatographic method for the production of a human immunoglobulin g solution for intravenous use |
| topic | immunoglobulin G production hemoderivate production intravenous gamma globulin production industrial chromatography downstream process |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X1998001100002 |
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