Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine

Detalhes bibliográficos
Autor(a) principal: Souza, Iaralice Medeiros de
Data de Publicação: 2013
Outros Autores: Silva, Milton Neto da, Figueira, Elza Scott, Leal, Maria de Lourdes, Jessouroun, Ellen, Abrantes, Shirley de Mello Pereira, Silveira, Ivna Alana Freitas Brasileiro da
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/32155
Resumo: Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
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spelling Souza, Iaralice Medeiros deSilva, Milton Neto daFigueira, Elza ScottLeal, Maria de LourdesJessouroun, EllenAbrantes, Shirley de Mello PereiraSilveira, Ivna Alana Freitas Brasileiro da2019-03-19T14:41:21Z2019-03-19T14:41:21Z2013SOUZA, Iaralice Medeiros de et al. Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine. Electrophoresis, Verlag Chemie, v. 34, n. 22-23, p.3221-3226, 2013.1522-2683https://www.arca.fiocruz.br/handle/icict/3215510.1002/elps.201300298engSingle validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccineinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Neisseria meningitidis group C is an encapsulated bacterium that causes several diseases and is associated with high mortality rates, thereby constituting a serious public health problem. Bio‐Manguinhos/Fiocruz is developing a conjugate vaccine by covalent attachment of capsular polysaccharide to hydrazide‐activated tetanus toxoid through reductive amination. It is necessary to quantify free components as a quality control process to prevent exacerbated adverse reactions and/or attenuation of vaccine immunogenicity. Thus, this study aimed to develop and validate a quality control method appropriate for the separation and quantification of free polysaccharide present in this conjugate N. meningitidis group C vaccine using CE. CZE was used to remove unbound polysaccharide, and the electrophoretic conditions were varied to optimize resolution. We were able to develop and validate the proposed method, which was linear and showed a matrix effect. Repeatability and partial reproducibility of the method were also evaluated. The robustness results showed that control of temperature is required for reliable results. The validated method will be used to evaluate the conjugate batches submitted for Phase III clinical studies and for routine quality control of the conjugate vaccine.Capillary electrophoresisMeningococcal vaccinePolysaccharide contentSingle validationinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1748https://www.arca.fiocruz.br/bitstream/icict/32155/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51ORIGINALSouza_et_al-2013-ELECTROPHORESIS.pdfSouza_et_al-2013-ELECTROPHORESIS.pdfapplication/pdf219573https://www.arca.fiocruz.br/bitstream/icict/32155/2/Souza_et_al-2013-ELECTROPHORESIS.pdf798dec4b8e8a23caa6055371d7fd51a7MD52TEXTSouza_et_al-2013-ELECTROPHORESIS.pdf.txtSouza_et_al-2013-ELECTROPHORESIS.pdf.txtExtracted texttext/plain26547https://www.arca.fiocruz.br/bitstream/icict/32155/3/Souza_et_al-2013-ELECTROPHORESIS.pdf.txt38073d2baf4f4a76e4161b7fd1928244MD53icict/321552019-04-04 02:03:05.819oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352019-04-04T05:03:05Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
title Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
spellingShingle Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
Souza, Iaralice Medeiros de
Capillary electrophoresis
Meningococcal vaccine
Polysaccharide content
Single validation
title_short Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
title_full Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
title_fullStr Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
title_full_unstemmed Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
title_sort Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
author Souza, Iaralice Medeiros de
author_facet Souza, Iaralice Medeiros de
Silva, Milton Neto da
Figueira, Elza Scott
Leal, Maria de Lourdes
Jessouroun, Ellen
Abrantes, Shirley de Mello Pereira
Silveira, Ivna Alana Freitas Brasileiro da
author_role author
author2 Silva, Milton Neto da
Figueira, Elza Scott
Leal, Maria de Lourdes
Jessouroun, Ellen
Abrantes, Shirley de Mello Pereira
Silveira, Ivna Alana Freitas Brasileiro da
author2_role author
author
author
author
author
author
dc.contributor.author.fl_str_mv Souza, Iaralice Medeiros de
Silva, Milton Neto da
Figueira, Elza Scott
Leal, Maria de Lourdes
Jessouroun, Ellen
Abrantes, Shirley de Mello Pereira
Silveira, Ivna Alana Freitas Brasileiro da
dc.subject.en.pt_BR.fl_str_mv Capillary electrophoresis
Meningococcal vaccine
Polysaccharide content
Single validation
topic Capillary electrophoresis
Meningococcal vaccine
Polysaccharide content
Single validation
description Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
publishDate 2013
dc.date.issued.fl_str_mv 2013
dc.date.accessioned.fl_str_mv 2019-03-19T14:41:21Z
dc.date.available.fl_str_mv 2019-03-19T14:41:21Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv SOUZA, Iaralice Medeiros de et al. Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine. Electrophoresis, Verlag Chemie, v. 34, n. 22-23, p.3221-3226, 2013.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/32155
dc.identifier.issn.pt_BR.fl_str_mv 1522-2683
dc.identifier.doi.none.fl_str_mv 10.1002/elps.201300298
identifier_str_mv SOUZA, Iaralice Medeiros de et al. Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine. Electrophoresis, Verlag Chemie, v. 34, n. 22-23, p.3221-3226, 2013.
1522-2683
10.1002/elps.201300298
url https://www.arca.fiocruz.br/handle/icict/32155
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
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