INVESTIGATIONS OF THE BIOLOGICAL DRUGS STABILITY BASED ON PROBIOTIC BACTERIA FOR VETERINARY USAGE

Abstract

The work was carried out in the Department of Quality Assurance of Medicines for Veterinary Medicine and Animal Husbandry of the Federal State Budgetary Scientific Institution "All-Russian Research and Technological Institute of Biological Industry" (FSBNU VNITIBP). Currently, the regulatory documents of the Russian Federation and the Eurasian Economic Union have established uniform requirements for the organization of production and quality control of medicines for medical and veterinary use. An important element of the life cycle of immunobiological medicinal products (ILPs) is the determination and control of their stability under various proposed storage conditions. Stability requirements apply to both the main and excipients included in the product: substances, antigens, buffer systems and other additives. In accordance with the recommendations of FAO/WHO and the documents of the Eurasian Economic Union on the assessment of probiotics, the thermal stability and stability in long-term storage in liquid and dry forms of strains of probiotic bacteria L. plantarum, strain 8RA3 (VKPM No. V-11007) and B. subtilis, strain M-8 (VKPM No. B-1948), deposited in the All-Russian Collection of Industrial Microorganisms (VKPM) FSUE GosNIIGenetics, the shelf life of probiotics at a storage temperature of 8-10 ° С is established: based on L. plantarum bacteria (3 months in liquid form, 9 months in dry form), B. subtilis bacteria (9 months in liquid form, 12 months in dry form).