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A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation
Provedor de dados: Brazilian Journal of Pharmaceutical Sciences
Autores: Lucena,Antônio Edson de Souza; Sampaio,Divaldo de Almeida; Silva,Ednaldo Rosas da; Paiva,Virgínia Florêncio de; Santiago,Ana Cláudia; Leite,Ana Cristina Lima.
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%...
Tipo: Info:eu-repo/semantics/article
Palavras-chave: Blood derivatives; Immunoglobulins; Polyethylene glycol; Ultrafiltration; Ion exchange chromatography.
Ano: 2010
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000400020