Data/hora: 03/06/2024 16:15:01

Provedor de dados: | Brazilian Journal of Pharmaceutical Sciences
País: | Brazil
Título: | A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation
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.
Data: | 2010-12-01
Ano: | 2010
Palavras-chave: | Blood derivatives; Immunoglobulins; Polyethylene glycol; Ultrafiltration; Ion exchange chromatography.
Resumo: | 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.
Tipo: | Info:eu-repo/semantics/article
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000400020
Editor: | Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação: | 10.1590/S1984-82502010000400020
Formato: | text/html
Fonte: | Brazilian Journal of Pharmaceutical Sciences  v.46 n.4 2010
Fonte: | info:eu-repo/semantics/openAccess