A ROUTINE HIGH-PERFORMANCE SIZE-EXCLUSION CHROMATOGRAPHY TO DETERMINEMOLECULAR-SIZE DISTRIBUTION OF HAEMOPHILUS-INFLUENZAE TYPE-B CONJUGATE VACCINES

High-performance size exclusion chromatography has been used to determ ine the molecular size distribution of Haemophilus influenzae type b ( Hib) conjugate vaccines. Both high molecular weight preparations of na tive Hib capsular polysaccharide coupled to tetanus toroid and low mol ecular weight vaccines with Hib oligosaccharides linked to the CRM197 nontoxic mutant diphtheria protein were analysed. Columns with differe nt fractionation ranges were used for the two kinds of vaccines. This method showed to be rapid, accurate and reproducible for different lot s of Hib vaccine of different composition produced by various manufact urers. It could replace more time-consuming chromatographic methods en abling control authorities to employ a single methodological approach for different Hib vaccines. (C) 1998 Elsevier Science Ltd. All rights reserved.