Биопрепараты: Профилактика, диагностика, лечение (Feb 2018)
Authentification and stability assessment of master-seed and control strains of pathogenic bacteria-causative agents of actual infections
Abstract
The paper presents the results of identification of a spectrum of biochemical activity and certification of 140 bacterial strains of I-II risk level deposited in the State collection of pathogenic microorganisms of Scientific centre for expert evaluation of medicinal products of the Ministry of health of the Russian Federation. Causative agents of meningitis, dysentery, salmonellosis and other acute gastrointestinal, pyoinflammatory infections, including nosocomial, and other epidemiologically significant infections which can be applied for manufacturing and an quality assessment medicinal and diagnostic preparations, including vaccines, toxoids, therapeutic and prophylactic bacteriophages, antimicrobic drugs, diagnostic serum, test system, nutrient media were evaluated. Correction of a taxonomic nomenclature of collection strains according to requirements of Bergey’s manual of systematic bacteriology (2nd ed) was provided. A possibility of selection of the analogs of cultures of the microorganisms deposited in national collections of other countries and applied by production and quality control of immunobiological medicines and also for quality assessment of laboratory researches is proved. Stability of pivotal phenotypic properties and lack of dissociation master-seed and test strains is confirmed at freeze-drying for over 40 years.
