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Published on: December 19, 2020
Relationships among physico-chemical and biological tests for a synthetic Hib-TT conjugate vaccine
Mario Landys Chovel Cuervo1, Lidia Rosa Pérez, Maite Oviedo
1Cuban Center for Quality Control of Drugs (CECMED), Calle 200, No. 1706 entre 17 y 19, CP 11600, Siboney, Playa, Ciudad de la Habana, Cuba. mariolandys@yahoo.es
Abstract:
The relationships among physico-chemical and biological tests were evaluated in this study for Cuban Hib vaccine, a tetanus toxoid conjugated with a polysaccharide obtained from chemical synthesis, in order to estimate the biological significance of the relevant physico-chemical assays for lot released. In order to get samples with theoretical different potencies, Hib-TT samples were stored at -20, 4, 25, 37 and 70 degrees C for 5 weeks and after they were evaluated by HPLC and Orcinol methods and for immunogenicity and bactericidal activity. We found strong relationships between HPLC and free PRP level (r2=0.9571), anti-PRP antibodies and bactericidal activity (r2=0.9649) and free PRP content and anti-PRP antibodies titres (r2=0.7671). A lower correlation was found for HPLC and anti-PRP titres (r2=0.5996). We demonstrate that it is possible to monitor this new product combining physico-chemical and biological tests in order to contribute to its characterisation.
