Novartis Ag

Novartis Vaccines and Diagnostics Srl

Daniela Proietti

Angela Bardotti

Stefano Ricci

The invention is based on methods that allow analysis of mixed meningococcal saccharides from multiple serogroups even though they share monosaccharide units. With a combination of saccharides from serogroups C, W135 and Y, the invention analyses sialic acid, glucose and galactose content. The glucose and galactose results are used to directly quantify saccharides from serogroups Y and W135, respectively, and the combined glucose and galactose content is subtracted from the sialic acid content to quantify saccharides from serogroup C. The three serogroups can thus be resolved even though their monosaccharide contents overlap. The three different monosaccharide analyses can be performed on the same material, without interference between the monosaccharides and without interference from any other saccharide materials in the composition (e.g. lyophilisation stabilisers). The method can be used to analyse total and free saccharide in conjugate vaccines and simplifies quality control of vaccines containing capsular saccharides from multiple serogroups.

Analysis of saccharide vaccines without interference

When analysing saccharides by HPAEC, the eluate from the column is typically analysed using a amperometric detector. According to the invention, amperometric detection is coupled with ultraviolet detection, with both methods being applied to the eluate. Thus the invention provides a method for analysing the eluate from a liquid chromatography column, wherein the eluate is analysed by both (a) amperometric detection and (b) ultraviolet detection. The information content derivable from using both sorts of detection advantageously exceeds that derivable from either of the two detection methods alone.

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Narni, Italy

Daniela Proietti