Requirements for standard viral vaccine samples for veterinary medicine

Abstract

One of the branches of domestic biotechnology is the production of immunobiological drugs, including vaccines for medical and veterinary purposes. Despite the general decline observed in the global economy in recent years, the pharmaceutical market is developing. In 2020, the biological drug market could exceed $250 billion. In the Russian Federation and the countries of the Eurasian Economic Union, serious actions are being taken to harmonize national regulatory requirements with international rules and foreign control systems in the field of the production of immunobiological drugs and quality control. It should be noted the price availability of domestic vaccines, their high adaptation to the Russian epizootic situation, since they were created on the basis of strains characteristic of the territory of the country and the Eurasian continent. For the prevention of diseases such as foot-and-mouth disease, anthrax, trichophytia, microsporia, brucellosis, domestic vaccines are used in Russia. The main component of the strategy for the production of veterinary vaccines to increase competition of products is ensuring their quality. Products of Russian companies that do not have the practice of applying international standards cannot be competitive. This leads to the loss of the domestic market. Currently, regulatory documents of the Russian Federation and the Eurasian Economic Union have established uniform requirements for the organization of the production and quality control of medicines for medical and veterinary use. Within the framework of these documents, areas related to the development and certification of standard samples of various levels are actively developing, the purpose of which is to quantify the specific activity of drugs and the metrological characteristics of the methods used to evaluate quality, stability indicators, as well as control of auxiliary substances. The use of auxiliary substances and pharmaceutical substances is regulated by regulatory documentation: GF, FFS, FS, FSP or industry standards. This is necessary, since heterogeneity of drug quality parameters is possible due to various factors, including uncontrolled and uncontrolled.