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A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation BJPS
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
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Production of intravenous human dengue immunoglobulin from Brazilian-blood donors BJPS
Gouveia,Frederico Leite; Oliveira,Renata Mendes Batista de; Lucena,Antônio Edson de Souza; Cordeiro,Marli Tenório; Leite,Ana Cristina Lima.
Dengue represents an important health problem in Brazil and therefore there is a great need to develop a vaccine or treatment. The neutralization of the dengue virus by a specific antibody can potentially be applied to therapy. The present paper describes, for the first time, the preparation of Immunoglobulin specific for the dengue virus (anti-DENV IgG), collected from screened Brazilian blood-donations. Production was performed using the classic Cohn-Oncley process with minor modifications. The anti-DENV IgG was biochemically and biophysically characterized and fulfilled the requirements defined by the European Pharmacopoeia. The finished product was able to neutralize different virus serotypes (DENV-1, DENV-2, and DENV-3), while a commercial IgG...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Viral infections; Dengue/treatment; Dengue/virus; Dengue/neutralization; Immunoglobulins/preparation; Plasma fractionation; Virus neutralization.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000400022
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