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

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 hy...

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Bibliographic Details
Published in:Electrophoresis 2013-12, Vol.34 (22-23), p.3221-3226
Main Authors: de Souza, Iaralice Medeiros, da Silva, Milton Neto, Figueira, Elza Scott, de Lourdes Leal, Maria, Jessouroun, Ellen, de Mello Pereira Abrantes, Shirley, da Silveira, Ivna Alana Freitas Brasileiro
Format: Article
Language:English
Subjects:
Capillary electrophoresis
Electrophoresis, Capillary - methods
Electrophoresis, Capillary - standards
Limit of Detection
Linear Models
Meningococcal vaccine
Meningococcal Vaccines - chemistry
Neisseria meningitidis
Polysaccharide content
Polysaccharides - analysis
Reproducibility of Results
Single validation
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Summary: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.
ISSN:0173-0835
1522-2683
DOI:10.1002/elps.201300298