2023
DOI: 10.30895/2221-996x-2023-23-4-570-583
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Experimental evaluation of the possibility of determining bacterial endotoxins in typhoid Vi polysaccharide vaccines using the gel-clot test

M. V. Abramtseva,
N. S. Alekhina,
E. D. Kolyshkina

Abstract: Scientific relevance. Currently, only the rabbit pyrogen test is used to test the Vianvac® typhoid Vi polysaccharide vaccine for pyrogenicity. As part of the product specification file, the gel-clot test for bacterial endotoxins (BE) will improve the reliability of quality control, as well as harmonise the requirements for the vaccine with the requirements outlined for this group of medicinal products by leading world pharmacopoeias.Aim. This study aimed at an experimental assessment of the applicability of th… Show more

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