Robust Assessment of Molecular Size Distribution of Meningococcal AC Vaccine.
The molecular size of meningococcal polysaccharides is an important physicochemical parameter that is related to immunogenicity and efficacy. A simple method for size-exclusion chromatography was developed, optimized, and applied for safe and rapid fractionation of meningococcal polysaccharide AC vaccine. Pooling of the fractions collected from size-exclusion chromatography was investigated and evaluated, rather than analyzing each fraction separately, for determining the percentages of meningococcal polysaccharide A and C that were eluted before the distribution coefficient of 0.5. Pooling is preferred rather than analyzing each fraction individually, as it is easily handled, faster, simpler, less expensive, more accurate, safe, and applicable. The developed method was validated and successfully applied for the determination of meningococcal polysaccharide vaccine serotype A and C in quality-control and commercial samples.
National Organization for Research and Control of Biologicals, 51 Wezaret El Zeraa St, Dokki, Giza, 12654, Egypt.
Asmaa R
AR
Hussein
Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El Aini St, 11562, Egypt.
Mamdouh R
MR
Rezk
National Organization for Research and Control of Biologicals, 51 Wezaret El Zeraa St, Dokki, Giza, 12654, Egypt.
Faten Abdel Aziz
FA
Fathalla
Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr El Aini St, 11562, Egypt.
Mostafa A
MA
Shehata
D002236:Carbohydrate Conformation; D016014:Linear Models; D022401:Meningococcal Vaccines / Q000032:analysis* / Q000737:chemistry*; D008970:Molecular Weight; D011134:Polysaccharides / Q000032:analysis* / Q000737:chemistry*
D022401:Meningococcal Vaccines; D011134:Polysaccharides