The development of bacterial capsular polysaccharide-protein conjugates represents a major advancement in prophylaxis against bacterial infections caused by Haemophilus influenzae type b, Neisseria meningitidis serogroups A, C, Y, W135 and thirteen Streptococcus pneumoniae serotypes.These vaccines are complex multicomponent biological products comprised of several polysaccharide conjugates and excipients. Since polysaccharide conjugates and their multicomponent formulations are not considered to be well defined biologicals, it is reasonably expected that, if consistently manufactured, these will have comparable potencies. To ensure equivalence between vaccine lots used in clinical trials and, later, commercially, a very comprehensive, complex analytical control strategy to monitor important characteristics needs to be developed. This talk will outline and discuss  critical quality attributes for polysaccharide conjugate vaccines, focusing on the analytical control strategies and methods for the release and characterization of the intermediates, polysaccharide conjugate components and the final multicomponent vaccine formulations. Strategies to monitor stability during storage will be discussed as well.

Analytical control strategies for polysaccharide conjugate vaccines

248th National Meeting (2014)

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