Abstract

CEDRE, Bárbara et al. Validation of the serum bactericidal assay for Neisseria meningitidis serogroups A, C and W₁₃₅. Vaccimonitor [online]. 2012, vol.21, n.2, pp.31-34. ISSN 1025-028X.

Serum bactericidal assay is considered the most efficient tool for measuring the immunity status in people vaccinated against N. meningitidis and it is the analytical support for the development of polysaccharide vaccines. Good Manufacturing Practice and Quality Control of Pharmaceutical Products regulate the validation procedure for manufacturing process and the analysis and control methods, especially for bioassays that are more variable than physicochemical assays. For that reason, the validation of bactericidal assay for the tilt method was carried out by the determination of precision, specificity, accuracy and robustness. The results were in the range of acceptance criteria, that is why this assay is considered suitable for the evaluation of the immune response induced by A, C and W₁₃₅ polysaccharide vaccines against meningococcal meningitis.

Keywords : N. meningitidis ; bactericidal assay; validation.

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