Polysaccharide Vaccines. Current Approaches to Quality Assessment Issues

Abstract

Relevance. Polysaccharide vaccine quality assessment must, on the one hand, comply with modern domestic and international regulatory documents, and on the other hand, reflect the characteristics of newly developed drugs. The list of drugs registered on the Russian market is constantly expanding due to the development of new effective vaccines and the introduction of new production sites. Thus, the expert requirements for assessing the quality of these drugs and the information content of the documents submitted as part of the registration dossier need to be updated.Aims. The aim is to update the expert assessment of quality in preclinical and clinical studies of polysaccharide vaccines, as well as to revise the evaluation of quality parameters depending on the composition and structure of the finished product.Conclusions. We highlight the key problematic aspects of assessing the protective properties of purified polysaccharides: in particular, the problems related to the natural immunity of animals to diseases caused by bacterial species that are relevant to humans and, as a result, the lack of an adequate experimental model. Modern trends in the characterization and subsequent confirmation of the structure authenticity of purified and conjugated polysaccharides are taken into account. An analysis of the latest international and domestic pharmacopoeial requirements for the quality of polysaccharide vaccines is carried out. The disadvantages of selected methodological approaches to the evaluation of quality parameters such as «Identification» and «Molecular mass distribution» are noted. It is shown that it is necessary to generate recommendations for the examination of polysaccharide vaccines which would unify the recommendations for completing registration dossiers and forming specification files by taking into account each individual peculiarity of this type of drugs.