A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation
Highly purified intravenous immunoglobulin G concentrate (IV IgG) was produced with the use of polyethylene glycol associated to a single-stage precipitation by ethanol, instead of the classic Cohn-Oncley process, which employs cold alcohol as the precipitating agent, in a three-stage process. Precipitation of crude fraction containing more than 95% of immunoglobulin G was performed by liquid chromatography with a cation exchanger, CM-Sepharose, as a stationary phase. During the process, the product was subjected to two-stage viral inactivation. The first stage was performed by the action of sodium caprylate, 30 mM at pH 5.1+/- 0.1, and the second stage was performed by the action of a solvent-detergent mixture. The finished product was formulated at 5% with 10% sucralose as the stabilizing agent. The process yields 3.3g of IgG/liter of plasma. The finished product analysis showed an anti-complementary activity lower than 1CH50. Polymer and aggregate percent levels were lower than 3% in the five batches studied. The analysis of neutralizing capacity showed the presence of antibacterial and antiviral antibodies in at least three times higher concentrations than the levels found in source plasma. The finished product fulfilled all purity requirements stated in the 4th edition of the European pharmacopeia.
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Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
2010
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oai:scielo:S1984-825020100004000202011-02-10A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivationLucena,Antônio Edson de SouzaSampaio,Divaldo de AlmeidaSilva,Ednaldo Rosas daPaiva,Virgínia Florêncio deSantiago,Ana CláudiaLeite,Ana Cristina Lima Blood derivatives Immunoglobulins Polyethylene glycol Ultrafiltration Ion exchange chromatography Highly purified intravenous immunoglobulin G concentrate (IV IgG) was produced with the use of polyethylene glycol associated to a single-stage precipitation by ethanol, instead of the classic Cohn-Oncley process, which employs cold alcohol as the precipitating agent, in a three-stage process. Precipitation of crude fraction containing more than 95% of immunoglobulin G was performed by liquid chromatography with a cation exchanger, CM-Sepharose, as a stationary phase. During the process, the product was subjected to two-stage viral inactivation. The first stage was performed by the action of sodium caprylate, 30 mM at pH 5.1+/- 0.1, and the second stage was performed by the action of a solvent-detergent mixture. The finished product was formulated at 5% with 10% sucralose as the stabilizing agent. The process yields 3.3g of IgG/liter of plasma. The finished product analysis showed an anti-complementary activity lower than 1CH50. Polymer and aggregate percent levels were lower than 3% in the five batches studied. The analysis of neutralizing capacity showed the presence of antibacterial and antiviral antibodies in at least three times higher concentrations than the levels found in source plasma. The finished product fulfilled all purity requirements stated in the 4th edition of the European pharmacopeia.info:eu-repo/semantics/openAccessUniversidade de São Paulo, Faculdade de Ciências FarmacêuticasBrazilian Journal of Pharmaceutical Sciences v.46 n.4 20102010-12-01info:eu-repo/semantics/articletext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000400020en10.1590/S1984-82502010000400020 |
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Lucena,Antônio Edson de Souza Sampaio,Divaldo de Almeida Silva,Ednaldo Rosas da Paiva,Virgínia Florêncio de Santiago,Ana Cláudia Leite,Ana Cristina Lima |
| spellingShingle |
Lucena,Antônio Edson de Souza Sampaio,Divaldo de Almeida Silva,Ednaldo Rosas da Paiva,Virgínia Florêncio de Santiago,Ana Cláudia Leite,Ana Cristina Lima A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation |
| author_facet |
Lucena,Antônio Edson de Souza Sampaio,Divaldo de Almeida Silva,Ednaldo Rosas da Paiva,Virgínia Florêncio de Santiago,Ana Cláudia Leite,Ana Cristina Lima |
| author_sort |
Lucena,Antônio Edson de Souza |
| title |
A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation |
| title_short |
A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation |
| title_full |
A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation |
| title_fullStr |
A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation |
| title_full_unstemmed |
A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation |
| title_sort |
new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation |
| description |
Highly purified intravenous immunoglobulin G concentrate (IV IgG) was produced with the use of polyethylene glycol associated to a single-stage precipitation by ethanol, instead of the classic Cohn-Oncley process, which employs cold alcohol as the precipitating agent, in a three-stage process. Precipitation of crude fraction containing more than 95% of immunoglobulin G was performed by liquid chromatography with a cation exchanger, CM-Sepharose, as a stationary phase. During the process, the product was subjected to two-stage viral inactivation. The first stage was performed by the action of sodium caprylate, 30 mM at pH 5.1+/- 0.1, and the second stage was performed by the action of a solvent-detergent mixture. The finished product was formulated at 5% with 10% sucralose as the stabilizing agent. The process yields 3.3g of IgG/liter of plasma. The finished product analysis showed an anti-complementary activity lower than 1CH50. Polymer and aggregate percent levels were lower than 3% in the five batches studied. The analysis of neutralizing capacity showed the presence of antibacterial and antiviral antibodies in at least three times higher concentrations than the levels found in source plasma. The finished product fulfilled all purity requirements stated in the 4th edition of the European pharmacopeia. |
| publisher |
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas |
| publishDate |
2010 |
| url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000400020 |
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