Quality Management System in Stavropol Research Anti-Plague Institute

The analysis of the structure of quality management system and the areas of its activity is presented. Trends for its further improvement are defined

Validation of Technological Process of Production of Liquid Brucellosis Diagnosticum for Agglutination Reaction, Suspension for Diagnostic Purposes

Presented are the results of validation of technological process of production of brucellosis diagnosticu

Minimizing Variability of Cascade Impaction Measurements in Inhalers and Nebulizers

The purpose of this article is to catalogue in a systematic way the available information about factors that may influence the outcome and variability of cascade impactor (CI) measurements of pharmaceutical aerosols for inhalation, such as those obtained from metered dose inhalers (MDIs), dry powder inhalers (DPIs) or products for nebulization; and to suggest ways to minimize the influence of such factors. To accomplish this task, the authors constructed a cause-and-effect Ishikawa diagram for a CI measurement and considered the influence of each root cause based on industry experience and thorough literature review. The results illustrate the intricate network of underlying causes of CI variability, with the potential for several multi-way statistical interactions. It was also found that significantly more quantitative information exists about impactor-related causes than about operator-derived influences, the contribution of drug assay methodology and product-related causes, suggesting a need for further research in those areas. The understanding and awareness of all these factors should aid in the development of optimized CI methods and appropriate quality control measures for aerodynamic particle size distribution (APSD) of pharmaceutical aerosols, in line with the current regulatory initiatives involving quality-by-design (QbD)

Epizootic Activity of the Central Caucasian High-Mountain Natural Plague Focus

Analysis of the long-term data made it possible to identify three periods of epizootic activity of the Central Caucasian high-mountain natural plague focus against the background of the overall downward trend. In the third period (2000-2010) the focus was shown to be under the intense negative influence of natural and anthropogenic factors that stipulated its depression. The natural factors were weather conditions unfavorable for life-sustaining activity of mountain ground-squirrels, the main plague carriers in this focus. Anthropogenic pressure over the focus manifested as follows. The quantity of cattle decreased, that resulted in decrease of territories of the mountain pasturelands, the natural habitats of mountain ground-squirrels. As areas suitable for life-sustaining activity of the mountain ground-squirrel populations reduced, the number of their settlements declined. With account taken for the effect of the anthropogenic influence stated above, short-term and medium-term prognoses of epizootic activity of Central Caucasian high-mountain natural plague focus indicate of rare non-intensive epizooties

Comparative Analysis of Experimental Series of Plague Live Vaccine as for Viability and Thermostability Indices

Comparative analysis of specified indices (viability, thermostability) of plague live vaccine preparations, produced in accordance with different biotechnological production schemes, have been carried out. Shown is that the combination of optimal temperature for Yersinia pestis strain EV biomass propagation (21±1) °C as well as optimal concentration proportion of bacteria and stabilizer in suspension with decreased optical density and volume facilitates effectual moisture removal out of preparation, thus stabilizing microbial cells viability index in the process of storage

Development of New Approaches of Obtaining the Hyperimmune Sera for Production of Medical Immunobiological Preparations

Developed were the new immunization schedules of obtaining plague, brucellar, anthrax, tularemia, cholera, leptospirosis, legionellosis and campilobacteriosis hyperimmune sera based on optimal combinations of specific protein antigenic complexes with immunomodulators, providing high specific immune response in 100 % of animals, significant reduction of immunization terms, material and labor input. Immune sera obtained are high quality biological material to be used for production of different diagnostic immunobiological preparations

Mastering of Technology of Production of Brucellosis Diagnostic Bacteriophages

Presented are technologies of production of brucellosis diagnostic bacteriophages developed on the basis of determination of optimal conditions of the phages reproduction. Stability of the finished product was evaluated using Shuhard control charts

Immune-Magnetic Absorbents Used for Express Diagnosis of Dangerous Infectious Diseases: Biotechnology Aspects and Experience of Application

Compositional micro-grained immune-magnetic absorbents (IMA) were obtained on the basis of silica - aluminocilicate, modified by polyglucin and sodium secondary alkylsulphate. IMA were shown to possess high adsorption activity due to their developed surface and implanted specific ligand, standard structural features, mechanical reliability, chemical and microbiological stability. The existence of magnetic material provided facilitation and convenience of operations with absorbents in analysis performance. Applying of IMA allowed to release of any mixtures with their adverse effect on reaction during samples preparing by means of rinsing the absorbent with fixed infected agent on it; concentrating the unknown pathogen to the extent possible increased the specificity and sensitivity of express-analysis methods (EIA and PCR), the time spending for analysis reduced substantially (up to 1-3hours)