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

• Published in: Journal of pharmaceutical and biomedical analysis 2016-02, Vol.120, p.283-289
• Main Authors: Morduš, M., Štimac, A., Brgles, M., Kurtović, T., Halassy, B.
• Format: Article
• Language: English
• Subjects: Colorimetry - methods; Humans; Meningococcal vaccine; N-Acetylneuraminic Acid - blood; N-Acetylneuraminic Acid - chemistry; Neisseria meningitides; Neisseria meningitidis; Neisseria meningitidis, Serogroup W-135 - chemistry; Neisseria meningitidis, Serogroup W-135 - isolation & purification; Neisseria meningitidis, Serogroup Y - chemistry; Neisseria meningitidis, Serogroup Y - isolation & purification; Polysaccharide content quantification; Polysaccharides, Bacterial - blood; Polysaccharides, Bacterial - chemistry; Serogroup W polysaccharide; Serogroup Y polysaccharide
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2015.12.013

[Display omitted] •Simple and fast colorimetric method for MenW or MenY PS content determination.•It is based on d-galactose or d-glucose quantification in respective PS hydrolysates.•Superior accuracy and precision compared to Ph.Eur. method for the same purpose.•Calculation of the possible regulatory requirement is provided. 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.