Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
Autor(a) principal: | |
---|---|
Data de Publicação: | 2013 |
Outros Autores: | , , , , , |
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. |
id |
CRUZ_0a4946c5c5e78f271eb18df2a68e41fa |
---|---|
oai_identifier_str |
oai:www.arca.fiocruz.br:icict/32155 |
network_acronym_str |
CRUZ |
network_name_str |
Repositório Institucional da FIOCRUZ (ARCA) |
repository_id_str |
2135 |
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) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Repositório Institucional da FIOCRUZ (ARCA) |
collection |
Repositório Institucional da FIOCRUZ (ARCA) |
bitstream.url.fl_str_mv |
https://www.arca.fiocruz.br/bitstream/icict/32155/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/32155/2/Souza_et_al-2013-ELECTROPHORESIS.pdf https://www.arca.fiocruz.br/bitstream/icict/32155/3/Souza_et_al-2013-ELECTROPHORESIS.pdf.txt |
bitstream.checksum.fl_str_mv |
8a4605be74aa9ea9d79846c1fba20a33 798dec4b8e8a23caa6055371d7fd51a7 38073d2baf4f4a76e4161b7fd1928244 |
bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 MD5 |
repository.name.fl_str_mv |
Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
repositorio.arca@fiocruz.br |
_version_ |
1798324803789127680 |