BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Анализ эффективности и безопасности вакцин для профилактики клещевого энцефалита
Get PDFThis article provides a review on efficacy and safety of tick-borne encephalitis vaccines licensed in the Russian Federation. It highlights that both Russian and imported tick-borne encephalitis vaccines demonstrate high immunogenicity, safety and epidemiological effectiveness in regions with high vaccine coverage. All licensed tick- borne encephalitis vaccines meet interchangeability criteria in terms of indications for use (with due regard to age limits), medical contraindications, vaccination schedules, vaccine composition, as well as safety, immunological activity and efficacy parameters. Timely and specific prophylaxis help reduce the incidence of tick-borne encephalitis in endemic regions.В статье приведен анализ эффективности и безопасности вакцин для профилактики клещевого энцефалита (КЭ), разрешенных для применения на территории Российской Федерации. Показано, что используемые в настоящее время вакцины КЭ отечественного и зарубежного производства обеспечивают высокую иммуногенность, безопасность и эпидемиологическую эффективность в регионах с массовым охватом вакцинацией. Все зарегистрированные вакцины соответствуют основным принципам взаимозаменяемости по показаниям к применению с учетом возрастных ограничений, перечню медицинских противопоказаний, схемам вакцинации, составу вакцин, а также показателям безопасности, иммунологической активности и эффективности. Своевременные меры специфической профилактики приводят к снижению заболеваемости КЭ в эндемичных регионах
Современные биологические/биотехнологические лекарственные препараты. Актуальные вопросы разработки и перспективы использования
No full textThe review provides with the information, related to the development, research and registration of new biological preparations, including the issues of terminology and classification. It also highlights the issues of and prospects for genetically engineered drugs, specific aspects of comparative studies to prove the similarity of a biosimilar and the original (reference) medicine, clinical use and interchangeability of preparations, prospects for the development of biotechnological medicines, expert evaluation of the quality of biological/ biotechnological medicines, modern methods of immunotherapy of allergic diseases by recombinant medicines, as well as the issues of cell technology and tissue engineering. The review also describes the topics discussed at the 14th International Conference «High Medical Technologies of 21st Century» (October 24-31, 2015, Spain), related to fundamental and applied research, development and introduction of new technologies and modern medicines into clinical practice
Ретроспективный анализ заболеваемости вирусным гепатитом B населения Российской Федерации с 2013 по 2017 г. в аспекте вакцинопрофилактики
Get PDFThe article presents the results of a retrospective analysis of viral hepatitis B incidence in the Russian Federation from 2013 to 2017, taking into account the use of vaccines included into the National Immunisation Schedule and the Immunisation Programme in Case of Epidemic Outbreaks. The analysis of the data revealed a trend towards a reduction in the incidence of acute and chronic forms of hepatitis B in the territory of the Russian Federation during the past five years. The reduction of viral hepatitis B incidence was achieved thanks to a higher vaccination coverage of both children and adults. The article presents an overview of monovalent and combination recombinant hepatitis B vaccines licensed in the Russian Federation. It describes the WHO position on preventive vaccination against viral hepatitis B, and pays special attention to vaccination of people at risk. The article considers promising areas for improving immunobiological products for hepatitis B prevention, including new technologies used in vaccine production, development and introduction of new adjuvants or adjuvants systems, and development of therapeutic vaccines
Современное состояние вопроса заболеваемости детей туберкулезом, препараты для профилактики и диагностики инфекции
No full textThe article analyses main epidemiological parameters of tuberculosis (TB) in children and adolescents in Russia. It was demonstrated that the incidence rate in this population, though decreasing, is still high. The disease incidence in children and adolescents arising from contacts with people with active TB is 30 and 25 times higher than the overall incidence rate in children and adolescents in Russia, respectively. Analysis of TB lesions in a major proportion of children and adolescents shows multi-drug resistant strains of Mycobacteria tuberculosis (MTB), and this calls for revision of approaches to preventive actions for this population. The tuberculine Mantoux test is of limited value when it comes to diagnosing TB in adolescents. Screening in adolescents and children older than 7 years is performed using Diaskintest® containing two MBT-specific antigens. Specific TB prevention for newborns is performed by vaccination with BCG and BCG-M living vaccines. The product was modified by a 30 % reduction of the number of BCG living cells per 1 mg of vaccine in order to reduce postvaccinal complications largely associated with residual virulence of the BCG substrain. Since 2012 BCG vaccine lots have been standardized to contain from 500 thousand to 1 million viable BCG cells per BCG vaccine dose and from 375 thousand to 575 thousand viable BCG cells per BCG-M vaccine dose
Питательные среды для выявления стафилококков в клинической и санитарной микробиологии
Get PDFThe article summarizes the new microbiological culture media produced in FSIS SRCAMB to improve the efficiency of diagnosis of infectious diseases, describes the advantages of these environments compared to foreign analogs, technological achievements in the field of drug development.В статье дана краткая характеристика новых микробиологических питательных сред, выпускаемых в ФБУН «Государственный научный центр прикладной микробиологии» Роспотребнадзора (ГНЦ ПМБ) с целью повышения эффективности диагностики инфекционных заболеваний, описаны преимущества этих сред по сравнению с импортными аналогами, технологические достижения в области разработки препаратов
Разработка математических моделей синтеза о-антигенов атоксигенными штаммами холерных вибрионов на основе модели синтеза о-антигена, секретируемого в процессе культивировании вирулентного штамма Vibrio сhоІеrае М-41 ОГАВА при производстве холерной вакцины
No full textThe paper contains the results of the development of mathematical models for O-antigen synthesis by atoxigenic cholera vibrio strains KM 262 biovar El Tor serovar Ogawa, KM 263 biovar El Tor serovar Inaba, and M 377 O139 serogroup based on the modeling of the synthesis of O-antigen, produced in the course of cultivation of the virulent Vibrio cholerae M 41 strain belonging to classical biovar, serovar Ogawa. The data obtained provide the possibility to successfully perform the task of up-scaling the designed pilot technology for cultivation of atoxigenic cholera vibrio strains to be utilized on commercial-scale bioreactors.В статье представлены результаты разработки математических моделей синтеза О-антигенов холерными вибрионами атоксигенных штаммов КМ 262 биовара Эль Тор серовара Огава, КМ 263 биовара Эль Тор серовара Инаба и M 377 О139 серогруппы на основе модели синтеза О-антигена, секретируемого при культивировании вибрионов Vibrio cholerae вирулентного штамма М-41 классического биовара серовара Огава. Полученные данные дают возможность успешно осуществить задачу масштабирования разработанной пилотной технологии культивирования холерного вибриона атоксигенных штаммов на промышленные культиваторы
Анализ потребностей в стандартных образцах, предназначенных для оценки качества биологических лекарственных средств
No full textQuality evaluation of biologicals entails some specific considerations and problems associated with inherent variability of biological systems. This has implications not only for biological and immunological test methods, but for physical and physico-chemical methods as well. Usage of reference standards (RSs) has an important role to play in the improvement of evaluation of biologicals’ quality. Absence of some industry RSs, which have the status of national RSs, makes it impossible to standardize corresponding products and to assess comparability of test results obtained by different manufacturers for similar (similarly named) products. The first step in the creation of the national system of RSs for medicines is the analysis of the demand for RSs used in quality evaluation of medicines, including biologicals. The analysis of the range of RSs demonstrated that existing industry RSs are not sufficient for performing quality evaluation of available biologicals. At present new industry RSs are being developed
Испытание на стерильность иммунобиологических лекарственных препаратов в России. История вопроса и современные требования
Get PDFSterility is one of the key parameters of biological safety of immunobiological medicinal products. The article traces the history of the development of sterility test methods for immunobiological medicinal products from as far back as 1961 and up to the current requirements laid down in the State Pharmacopoeia of the Russian Federation, 13th edition. The article provides a detailed analysis of major approaches to the improvement of medicines quality evaluation based on this parameter, namely to the choice of: optimal growth media and methods of their evaluation, sensitive test strains, incubation conditions, the number of test samples (i.e., sample size) required for reliable demonstration of batch sterility; as well as approaches to the development of a test design that would accommodate specific aspects of production and use of immunobiological products. The article dwells upon the longstanding use of the sterility testing scheme developed in the national agency for control of immunobiological products — L.A. Tarasevich State Institute for Standardization and Control of Medicinal Immunobiological Products. The article analyses the current status of harmonisation of requirements for sterility testing of immunobiological products and other groups of medicines with those of the leading world pharmacopoeias, and prospects of using these requirements in the Eurasian Economic Union
