SAFETY AND STABILITY OF ANTIGEN FROM BRUCELLA MELITENSIS REV-1 STRAIN

Antigens obtained from various strains of pathogens play a key role in the development of vaccines and diagnostic tools to combat infectious diseases. One such pathogen is Brucella melitensis, the causative agent of brucellosis, a serious zoonosis that affects both animals and humans. The article presents the results of a study to assess the safety and stability of the antigen from the Brucella melitensis Rev-1 strain obtained by submerged cultivation in bioreactor, which will reduce the risks of side effects in vaccinated animals and the risks of non-specific reactions in the serological diagnosis of brucellosis. The result of study revealed that the inactivated antigen from the B. melitensis Rev-1 strain at a concentration of 1 cm3 - 2x109 is a stable and safe drug. Brucellosis antigen, when administered to laboratory mice, does not cause pathological changes characteristic of the infectious process. The stability study showed that, despite exposure to extreme temperatures for 6 days and 6 months at the storage temperature, the veterinary drug retains its full stability. Thus, the laboratory studies showed that the developed drug meets current GMP requirements. The study used microbiological, serological and biotechnological research methods. The practical significance of the study is based on the introduction into production of diagnostic test systems and kits using antigens and hyperimmune serums, such as AT, CFT, RBT, etc., as well as in the production of immunobiological drugs and vaccines against brucellosis using antigens.