title: Simple alternative to sialic acid determination in meningococcal polysaccharides W or Y.
abstract: 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 in use 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 galactose or glucose quantification in MenW or MenY PS hydrolysate, respectively. Intra- and inter-assay precision and accuracy of the novel method have 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 galactose or glucose content in MenW or MenY PS, respectively, and revealed in detail the stoichiometric calculation behind it.
authors.affiliation: Institute of Immunology Inc., Quality Control Department, Rockefellerova 2, HR-10000 Zagreb, Croatia.
authors.forename: M
authors.initials: M
authors.lastname: Morduš
authors.affiliation: University of Zagreb, Centre for Research and Knowledge Transfer in Biotechnology, Rockefellerova 10, HR-10000 Zagreb, Croatia.
authors.forename: A
authors.initials: A
authors.lastname: Štimac
authors.affiliation: University of Zagreb, Centre for Research and Knowledge Transfer in Biotechnology, Rockefellerova 10, HR-10000 Zagreb, Croatia.
authors.forename: M
authors.initials: M
authors.lastname: Brgles
authors.affiliation: University of Zagreb, Centre for Research and Knowledge Transfer in Biotechnology, Rockefellerova 10, HR-10000 Zagreb, Croatia.
authors.forename: T
authors.initials: T
authors.lastname: Kurtović
authors.affiliation: University of Zagreb, Centre for Research and Knowledge Transfer in Biotechnology, Rockefellerova 10, HR-10000 Zagreb, Croatia. Electronic address: bhalassy@unizg.hr.
authors.forename: B
authors.initials: B
authors.lastname: Halassy
mesh_terms: D003124:Colorimetry / Q000379:methods; D006801:Humans; D019158:N-Acetylneuraminic Acid / Q000097:blood* / Q000737:chemistry; D038582:Neisseria meningitidis, Serogroup W-135 / Q000737:chemistry / Q000302:isolation & purification*; D038581:Neisseria meningitidis, Serogroup Y / Q000737:chemistry / Q000302:isolation & purification*; D011135:Polysaccharides, Bacterial / Q000097:blood* / Q000737:chemistry
chemical_list: D011135:Polysaccharides, Bacterial; D019158:N-Acetylneuraminic Acid
keywords: Meningococcal vaccine; Neisseria meningitides; Polysaccharide content quantification; Serogroup W polysaccharide; Serogroup Y polysaccharide