Scientific journal
Scientific Review. Biological science
ISSN 2500-3399
ПИ №ФС77-57454

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STUDIES OF PRODUCTION STABILITY AND OF QUALITY INDEXES OF THE BRUCELLOSIS DIAGNOSTICUM, LIQUID FOR AGGLUTINATION TEST, SUSPENSIONS FOR DIAGNOSTIC PURPOSES

Kulichenko A.N. 1 Zuenko A.A. 1 Kogotkova O.I. 1 Gridina T.M. 1 Lyamkin G.I. 1 Lyapustina L.V. 1
1 The Federal Government Public Health Institution Stavropol Plague Control Institute
Over the difficult epizootologic-epidemiologic situation with brucellosis, sanitary and epidemiological service and practical health-protection institutions constantly need medical immunobiological drugs for laboratory diagnostics of this infection. Liquid brucellar diagnosticum for conglutination reaction and suspension for clinical purposes are widely used for serum diagnostics of brucellosis. Presented are results of study into stability of production and key quality performance of brucellar diagnosticum, when stored for long and subject to high temperatures, that testify to the possibility of extending the drug’s shelf life and on widening the range of transportation temperature. It is shown by experiments that specific activity of the drug preserves for three years (follow-up period). Results of appraisal of the drug production critical subprocesses during one production cycle prove that the biotechnological process is stable and complies with the normative documents’ requirements.