engleski

Simple alternative to sialic acid determination in meningococcal polysaccharides Y or W

Physicochemical methods are the primary tests used to ensure that batches of meningococcal polysaccharide (PS) antigens are manufactured consistently to those shown to be safe and effective in clinical trials. Although modern physicochemical methods of analysis providing structural information about the antigens have been developed and used, simpler assays, which can be readily validated, are still preferred for polysaccharide batch release. The simple and cheap method for Neisseria meningitidis serogroup W or Y polysaccharide (MenW or MenY PS) content quantification has been developed. This colorimetric method is based on the glucose or galactose quantification in MenY or MenW PS hydrolysate, respectively. Intra- and inter-assay precision and accuracy of the novel method has been demonstrated, in comparison to the same properties of the current regulatory approved method for the same purpose – sialic acid quantification. We provided the calculation of the possible future regulatory requirement for the glucose/galactose content in MenY and MenW PS, and revealed in detail the stoichiometric calculation behind it.

Neisseria meningitidis; Meningococcal vaccine; Serogroup W polysaccharide; Serogroup Y polysaccharide; Polysaccharide content quantification

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