Prophylactic immunisation against brucellosis is part of the National Immunisation Schedule for Epidemic Settings. The immunisation is performed with a live vaccine—a lyophilized suspension of the Brucella abortus strain 19 BА in a stabilizing medium. The paper presents the results of quality evaluation of 9 batches of live brucellosis vaccine that were submitted to the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation for assessment of the product’s compliance with the established specifications. The paper also presents the results of evaluation of the passport information provided by the manufacturer for these batches. There is no doubt about the need for objective quality evaluation of brucellosis vaccines as well as about the significance of its improvement.The aim of study was to assess the prospects for improving quality evaluation of live brucellosis vaccines in terms of Specific activity (concentration of microbial cells, number of living microbial cells, number of cutaneous doses).Materials and methods: specific activity (concentration of microbial cells and number of living microbial cells) was determined by visual and microbiological methods using the industrial reference standard of brucellosis vaccine OSO 42-28-396-2018, batch 6 and the bacterial suspension of the Brucella abortus strain 19 BА acquired from the joint stock company Scientific and Production Association “Microgen” in 2016. The number of cutaneous doses in the brusellosis vaccine was determined by the calculation method. Statistical processing of the results was performed using Microsoft Excel.Results: there was a mismatch between the brucella concentration coefficient of 1.7×109 microbial cells/mL determined by comparison with the industrial reference standard of bacterial suspension turbidity, 10 IU and the actual concentration of microbial cells obtained in the study. According to preliminary results, the brucella concentration coefficient corresponding to the industrial reference standard of bacterial suspension turbidity, 10 IU can reach 3.0×109 microbial cells/mL.Conclusions: the obtained results can serve as a basis for amending the data on the brucella concentration coefficient in the Passport and the Instructions for use of the industrial reference standard of bacterial suspension turbidity, 10 IU, as well as the Specific activity section (concentration of microbial cells, number of living microbial cells, number of cutaneous doses) of the established specifications for the brucellosis vaccine. Before amending the information on the brucella concentration corresponding to 10 IU in the Passport and the Instructions for use of the reference standard of bacterial suspension turbidity (OSO 42-28-85P), additional studies should be performed with other types of brucella.

В соответствии с требованиями Государственной фармакопеи Российской Федерации (XIII издание, том III) на вакцину чумную живую при проведении испытания специфической активности и термостабильности производственных серий вакцины необходимо использование стандартного образца для оценки стабильности и приемлемости полученных результатов. Так как Международный стандартный образец вакцины чумной отсутствует, то аттестация новой серии отраслевого стандартного образца (ОСО) вакцины чумной живой для контроля специфической активности и термостабильности производственных серий вакцины необходима и актуальна. Для этого разработали программу аттестации, установив в ней схему и объем проводимых исследований для получения статистически значимых результатов. В качестве кандидата в ОСО использовали производственную серию препарата, удовлетворяющую требованиям нормативной документации на вакцину чумную живую. Аттестуемыми характеристиками являются: «Специфическая активность: концентрация микробных клеток», «Специфическая активность: процент живых микробных клеток» и «Термостабильность». В статье представлены результаты аттестации и статистически обработанные результаты испытаний по показателям: «Средняя масса и однородность по массе», «Потеря в массе при высушивании» новой серии ОСО вакцины чумной живой. Приведены результаты исследования по показателю «Специфическая активность: иммуногенность». Итоги применения предыдущей серии ОСО вакцины чумной живой (ОСО 42-28-392-2013) и мониторинга стабильности ее аттестованных характеристик показали возможность увеличения срока годности ОСО на 6 месяцев по отношению к установленному (с 2 до 2,5 лет). Все аттестованные и дополнительные характеристики утверждены в документах на научно-техническую продукцию ОСО 42-28-392-2017 вакцины чумной живой: паспорт, макеты этикеток упаковок и инструкция по применению. Ключевые слова: отраслевой стандартный образец (ОСО); вакцина чумная живая; специфическая активность; концентрация микробных клеток; процент живых микробных клеток; иммуногенность; термостабильность Для цитирования: Касина ИВ, Алексеева СА, Фадейкина ОВ, Немировская ТИ, Волкова РА. Аттестация новой серии отраслевого стандартного образца для контроля специфической активности и термостабильности вакцины чумной живой. БИОпрепараты. Профилактика, диагностика, лечение. 2018;18(4):262-267. Контактное лицо: Касина Ирина Владимировна; kasina@expmed.ruIn accordance with the State Pharmacopoeia (SPh) requirements for live plague vaccine, a reference standard has to be used when testing the specific activity and thermal stability of plague vaccine commercial batches in order to assess the consistency and acceptability of the test results. Since there is no international reference standard for plague vaccine, the certification of a new batch of the industry reference standard (IRS) of live plague vaccine in terms of the above-mentioned quality parameters is an urgent challenge. Therefore, a certification programme for the industry reference standard was developed that establishes the design and scope o...

Relevance. Polysaccharide vaccine quality assessment must, on the one hand, comply with modern domestic and international regulatory documents, and on the other hand, reflect the characteristics of newly developed drugs. The list of drugs registered on the Russian market is constantly expanding due to the development of new effective vaccines and the introduction of new production sites. Thus, the expert requirements for assessing the quality of these drugs and the information content of the documents submitted as part of the registration dossier need to be updated.Aims. The aim is to update the expert assessment of quality in preclinical and clinical studies of polysaccharide vaccines, as well as to revise the evaluation of quality parameters depending on the composition and structure of the finished product.Conclusions. We highlight the key problematic aspects of assessing the protective properties of purified polysaccharides: in particular, the problems related to the natural immunity of animals to diseases caused by bacterial species that are relevant to humans and, as a result, the lack of an adequate experimental model. Modern trends in the characterization and subsequent confirmation of the structure authenticity of purified and conjugated polysaccharides are taken into account. An analysis of the latest international and domestic pharmacopoeial requirements for the quality of polysaccharide vaccines is carried out. The disadvantages of selected methodological approaches to the evaluation of quality parameters such as «Identification» and «Molecular mass distribution» are noted. It is shown that it is necessary to generate recommendations for the examination of polysaccharide vaccines which would unify the recommendations for completing registration dossiers and forming specification files by taking into account each individual peculiarity of this type of drugs.

Preventive immunisation against anthrax is carried out in accordance with the national Immunisation Schedule for Epidemic Settings. The vaccination is performed using a live vaccine—a freeze-dried suspension of Bacillus anthracis STI-1 vaccine strain spores in a stabilizing media. Improvement of the quality control of immunobiological medicines is a pressing issue and an integral part of the quality management system.The aim of study was to streamline quality control of live anthrax vaccine in terms of the following test parameters: identification and specific activity (total spore concentration).Materials and methods: identification and specific activity (total spore concentration) tests were performed for samples of live anthrax vaccine, batch 266, produced by the 48 Central Scientific Research Institute. The identification test was performed using the B. anthracis immunochromatography test kit for express detection and identification of anthrax pathogen spores produced by the State Research Center for Applied Microbiology and Biotechnology (Obolensk). The specific activity (total spore concentration) was assessed by the visual method and calculated in the Goryaev chamber using the industry reference standard of bacterial suspension turbidity equivalent to 10 IU—OSO 42-28-85 (by the Scientific Centre for Expert Evaluation of Medicinal Products). The number of live spores in live anthrax vaccine was determined by the microbiological method (by inoculating media). The statistical processing of the results was performed using Excel and Statistica 10.0.Results: the authors provided theoretical and experimental substantiation to support the feasibility of using immunochromatography as an alternative identification test method for live anthrax vaccine. Test samples dilutions of 108 microbial cells per millilitre and 109 microbial cells per millilitre are used in the test. The authors developed a test procedure for determination of the total spore concentration (specific activity) in live anthrax vaccine using an industry reference standard of turbidity equivalent to 10 IU, and proposed a formula for calculation of the total spore concentration.Conclusions: the developed test procedures could be recommended for inclusion in the live anthrax vaccine specification files as alternative methods of quality control.

Typhoid fever is an acute infectious disease caused by Salmonella enterica subsp. enterica serovar Typhi (S. Typhi), which is still extremely common in endemic low- and middle-income countries of Asia and Africa. Industrialised countries may also be affected by typhoid fever outbreaks due to booming international tourism, and natural disasters. Given S. Typhi progressive resistance to antibiotics, high epidemiological burden, and lack of adequate sanitation and hygiene in a number of regions, the introduction of new treatment protocols and the improvement of preventive vaccination are critical tasks in global healthcare. The aim of the study was to highlight the main historical aspects of the typhoid vaccine development, to summarise data on the licensed vaccines and promising approaches to the development of new typhoid vaccines. The paper describes the current epidemiological situation of typhoid fever globally and in the Russian Federation. It dwells upon the global experience in typhoid vaccine development from the production of an inactivated vaccine to the development of conjugated vaccines. The paper summarises data on Russian and foreign-made typhoid fever vaccines currently available in the global pharmaceutical market. It outlines the main trends in the development of vaccines against the disease caused by S. Typhi. The paper demonstrates the need for improving the efficacy of existing vaccines and development of new typhoid combination vaccines.