DEVELOPMENT OF AN ANTIRABIC REFERENCE VACCINE FROM THE RABIES VIRUS, STRAIN "SHCHELKOVO-51"

The article presents data on the development, certification and application of the national industry standard of the immunogenicity of rabies vaccine for animals. The relevance and economic feasibility of using the national reference vaccine in the production and quality control of immunopreparations, as well as in the development and introduction  of innovative technologies, is shown. The investigations were carried out in the Department of Molecular biology and virology of the All Russian Scientific Research and Technical Institute of the Biology Industry (ARSRTIBI) and FFE “Shchelkovskiy biofactory”. The reference vaccine immunogenic potency was evaluated in vivo by volumetric estimation NIH with white mice and in vitro by the amount of glycoprotein in the ELISA and expressed in units of ME / cm3 and GE / cm3, respectively. The universal methodology of the standard samples accreditation based on the parallel testing of international standard sample and researched vaccine from VB (Shchelkovo strain) was used and next statistical analysis by parallel-line method in the Microsoft Excel program unit. The obtained results showed that the first domestic reference vaccine allows to estimate immunogenic potency of antirabic vaccine in the international units. After the usage of the standard sample were prepared and certified the new reference vaccines series for production and control of the production batches domestic antirabic vaccines in accordance with the approved specifications.