Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/32155
Title: Single validation of CE method for determining free polysaccharide content in a Brazilian meningococcal C conjugate vaccine
Authors: 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
Affilliation: 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 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.
Abstract: 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.
Keywords: Capillary electrophoresis
Meningococcal vaccine
Polysaccharide content
Single validation
Issue Date: 2013
Citation: 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.
DOI: 10.1002/elps.201300298
ISSN: 1522-2683
Copyright: open access
Appears in Collections:INCQS - Artigos de Periódicos
Biomanguinhos - Artigos de Periódicos

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