BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Лекарственные препараты моноклональных антител нового поколения (проблемы и перспективы)
No full textThe article provides the information on issues related to the clinical use of preparations of monoclonal antibodies (MAb), and the prospects for developing preparations based on modified MAbs. MAb preparations based on recombinant proteins show the consistency of physical and chemical properties as well as high specificity. New class of preparations based on MAbs show great potential of targeted therapeutic influence on important pathogenetic mechanisms of disease development. It has proved to be successful against severe chronic diseases such as autoimmune cancer, infectious and allergic diseases, as well as in transplantation for the treatment and prevention of transplant rejection. The development and manufacture of MAb preparations based on a whole immunoglobulin molecule, as well as preparations of modified antibodies with a specific set of functions associated with individual structural elements of the molecule is now possible due to genetic engineering and transgenic animals technologies. Preparations based on modified MAb can exist i
СТАТЬЯ ОТОЗВАНА: Биоаналоги - преимущества и перспективы
Get PDFRETRACTED ARTICLEBiotechnologie is a rapidly developing branch of modern science, which is increasingly used in various fields, especially in medicine. Increasingly developed and introduced into medical practice of new Biopharmaceuticals - medicines derived from modern biotechnology. The development of technology in the production of “similar” medicines is gaining momentum and leads to a reduction in the cost and availability of drugs. On biotech drugs now pinning major hopes on a more affordable means of combating the most dangerous non-communicable diseases of modernity, such as cancer, multiple sclerosis, Alzheimer’s disease, storage diseases, etc. In this review we will discuss what is the difference between the original medicinal substance from the generic, and what is the bioequivalent. To date, the biosimilars market is actively developing and has very good growth prospects. According to experts of the pharmaceutical industry in the coming years, the biologics will be at least 50% of all medicines
Тест-система для диагностики BK вирусной инфекции человека методом полимеразной цепной реакции в режиме «реального времени»
Get PDFThe presented work comprises information about developed by Republic Scientific and Practical Center for Epidemiology and Microbiology the diagnostic kit for detection the BK virus DNA in clinical samples by the real-time Polymerase Chain Reaction method. Accomplished studies showed high level its diagnostic sensitivity and specificity. Suitability of developed kit for laboratory BK virus diagnosis was demonstrated.Настоящая работа содержит информацию о разработанной на базе ГУ «Республиканский научно-практический центр эпидемиологии и микробиологии» диагностической тест-системе, основанной на методе количественной ПЦР в режиме «реального времени». Проведенные исследования показали высокие значения диагностической чувствительности и специфичности тест-системы. Продемонстрирована возможность использования разработанного препарата для лабораторной диагностики полиомавирусной инфекции
Актуальные вопросы стандартных образцов в сфере обращения биологических лекарственных средств
No full textPharmacopoeial analytical methods involving reference standards (RS) are used for manufacture and quality control of medicinal products, including biologicals, these RS should now to be called pharmacopoeal. The introduction of the mentioned term reflects special drug characteristics, which are regulated not by the State Union Standards but by the Russian State Pharmacopoeia in terms of quality control. Drug and RS special characteristics require the establishment of legal and methodological framework. The recommendations stated in ISO REMCO are general do not fully cover the special aspects of the certification of reference standards for each specific area. The documents of the Federal Agency for Technical Regulating and Metrology (Rosstandart) on reference standards can not be used for biological medicinal products due to their specificity as the test methods do not allow to separate systematic and random components of uncertainty of test results, as required by Rosstandart. The regulatory framework for biological RS should be developed on the basis of WHO and ICH Guidelines. The classification of drug reference standards and the list of priority documents required for the elaboration of normative and procedural framework regulating their development, certification, approval and use is considered in the article. The development of the documents for the mentioned system is exemplified by a new pattern for an RS certificate
Набор для выявления антител к возбудителям особо опасных вирусных инфекций Ласса и Эбола методом непрямой иммунофлуоресценции
No full textTimely diagnosis of particularly dangerous infections caused by viruses Ebola and Lassa is crucial in organization of anti-epidemic measures in the case of important of the disease on the territory of the Republic of Belarus. The main method of rapid response at revealing hemorrhagic fevers Lassa and Ebola still is the method of indirect immunofluorescence. In this work the elaboration of the kit for detection of antibodies to exciters of extremely dangerous viral infection Lassa and Ebola by indirect immunofluorescence method is described.Своевременная диагностика особо опасных инфекций, вызванных вирусами Ласса и Эбола, является ключевым моментом в организации противоэпидемических мероприятий в случае завоза заболевания на территорию республики Беларусь. Основным методом быстрого реагирования при выявлении геморрагических лихорадок Ласса и Эбола, по-прежнему, является метод непрямой иммунофлуоресценции. В работе представлена разработка набора для выявления антител к особо опасным вирусным инфекциям Ласса и Эбола методом непрямой иммунофлуоресценции «Белар-РИФ-ЛАС-ЭБОЛ» ТУ BY 100558032.194-2011
Персональный и коллективный иммунитет при вакцинации
No full textThe present article adduces the evidence in support of the need in the development of personalized vaccines and provides with case studies, substantiating the possibility of the mentioned approach. In order to personalize vaccines one should perform preliminary determination of antibody titers (or delayed-type hypersensitivity skin testing) and the subsequent correction of the immunity in patients with low titers of protective antibodies or hyperimmunization symptoms. Vaccine personalization does not require serious financial expenses. The article provides with the advantages of vaccine personalization and the measures that should be taken to achieve this goal. The difficulties of the personalization and the ways to overcome them are described in the article. Vaccine personalization does not require serious financial expenses. It will contribute to the development of preventive vaccination. Personalization of vaccines is necessary for achieving herd immunity, which leads to the reduction in the incidence of the mentioned infection and usually to the reduction of agent circulation. «Immune domain», which includes mostly recovered and vaccinated patients as well as naturally immuned individuals (by circulating infectious agents), plays a decisive role in the development of herd immunity. The effectiveness of herd immunity is reduced due to genetic variability of an agent, frequent vaccination refusals and rejections. Long-term herd immunity is stipulated by immunological memory
Научно-методические разработки биотехнологий производства иммунобиологических препаратов для экспресс-диагностики инфекционных заболеваний и детекции их возбудителе
Get PDFThe present article describes the scientific and methodological development of biotechnological manufacture of test-system components (diagnostic preparations) for instant diagnosis of plague, brucellosis, tularemia, anthrax, cholera. In this regard, in the first place the effective methods for obtaining complete antigenic complexes used for immunizing animals for the purpose of developing highly potent immune sera have been established. These antisera were used in determining optimum parameters of manufacture on the basis of their diagnosticums. Methodical basis of developing magnetic immunosorbents for selective concentration of infectious agents and their instant diagnosis methods has been mentioned. Moreover, the article describes the development of piezoelectric quartz crystal biosensors to detect plague, brucellosis and tularemia pathogens by gravimetric flow injection analysis, allowing to quickly implement the process of reliable identification of a test pathogen in antigen-antibody complex.Представлены научно-методические разработки биотехнологий производства компонентов тест-систем (диагностических препаратов) для экспресс-диагностики чумы, бруцеллеза, туляремии, сибирской язвы, холеры. Для этого, прежде всего, были отработаны эффективные методики получения полноценных антигенных комплексов, применяемых для иммунизации животных в целях получения высокоактивных иммунных сывороток. Полученные иммунные сыворотки были использованы при определении оптимальных параметров производства на их основе диагностикумов. Приведены методические основы конструирования магноиммуносорбентов для селективного концентрирования возбудителей инфекционных заболеваний и их индикации экспресс-методами. Кроме того, приведена разработка пьезокварцевых биосенсорных устройств для выявления возбудителей чумы, бруцеллеза, туляремии в гравиметрическом проточно-инжекционном анализе, позволяющих быстро реализовать процесс достоверного распознавания исследуемого патогена в образовавшемся комплексе антиген-антител
Адъюванты на основе углеводов для производства вакцин
Get PDFAddition of adjuvants is a generally recognized method of enhancing the immunogenicity of vaccines. There is a large variety of adjuvants, therefore the choice of an adjuvant is based on the comparison of adjuvants efficacy in animal models, as well as assessment of their safety and tolerability. There are many different groups of substances that may have adjuvant properties, but relatively little attention is paid to carbohydrate-based adjuvants, despite the fact that they are compatible with live vector vaccines, safe, well tolerated, and their production is not laborious. Thanks to these advantages the use of these particular adjuvants in combination with any type of vaccine, including vector vaccines and DNA vaccines, may be most appropriate and promising. This review examines various types of carbohydrate adjuvants and the mechanisms that determine their efficacy. Общепризнанным способом усиления иммуногенности вакцин является добавление в их состав адъювантов. Последние характеризуются большим разнообразием, поэтому подбор адъюванта осуществляется путем сравнения эффективности адъювантов на моделях животных, а также оценки их безопасности и переносимости. Среди множества различных групп веществ, потенциально обладающих адъювантными свойствами, сравнительно мало внимания уделяют адъювантам на основе углеводов, несмотря на то, что они совместимы с живыми векторными вакцинами, безопасны, хорошо переносятся, а их производство не отличается трудоемкостью. Благодаря этим преимуществам применение именно таких адъювантов в сочетании с любым типом вакцины, в том числе с векторной или ДНК-вакциной, может быть наиболее целесообразным и перспективным. В настоящем обзоре рассмотрены различные типы углеводных адъювантов и механизмы, определяющие их эффективность
10 лет кожной пробе с аллергеном туберкулезным рекомбинантным (Диаскинтест®) и 110 лет туберкулиновой пробе Манту - сравнение эффективности
No full textThe article compares results reported in national and foreign literature concerning tuberculosis detection by various in vivo (skin tests such as the Mantoux test and Diaskintest® (a skin test with a recombinant tuberculosis allergen)) and in vitro methods (IGRA tests). A positive reaction to the Mantoux test, which has been used for over 100 years as part of mass immunization against tuberculosis, can be indicative of both earlier vaccination and of infection caused by virulent Mycobacteria tuberculosis. Given the mass scale of BCG vaccination, the positive reaction to tuberculin loses its predictive value for assessing the risk of tuberculosis. Diaskintest®, a recombinant tuberculosis allergen, was developed in Russia in early 2000s, authorized in 2008 and has been used in the national healthcare system since 2009. This is a recombinant fusion protein ESAT6-CFP10 produced using Echerichia coli BL21(DE3)/pCFP-ESAT. Differential diagnosis between post vaccination (BCG) and bacterial allergic reactions using Diaskintest® demonstrated high efficacy of the product - detection of tuberculosis in people with a positive reaction to the test was much higher than that of the Mantoux test. Both Diaskintest® and IGRA tests usually do not produce false negative reactions. Therefore no additional examination of non-infected people is needed, and the preventive therapy is given only to those people who have a high risk of developing tuberculosis
Разработка метода определения биологической активности препаратов эритропоэтина in vitro
No full textThe method for the assessment of biological activity of erythropoietin preparations in vitro on TF-1 sensitive cells culture has been developed. The special characteristics of measurements and calculations of the biological activity of erythropoietin with different levels of glycosylation in vivo and in vitro. Linear response ranges for cell lines to erythropoietin and its hyperglycosylated analogue differ and make (0.39-0.56 ng/ml) and (3.1-12.5 ng/ml), respectively. The results have shown the possibility of using cellular test for comparing and assaying the activity of erythropoietin analogues in standard international units of biological activity (IU) set for erythropoietin.Разработан метод оценки биологической активности препаратов эритропоэтина in vitro на культуре чувствительных клеток TF-1. Исследованы особенности измерения и расчета биологической активности эритропоэтинов с различным уровнем гликозилирования в тестах in vivo и in vitro. Диапазоны линейного ответа клеточной линии на эритропоэтин и его гипергликозилированный аналог отличались и составляли (0,39-0,56 нг/мл) и (3,1-12,5 нг/мл) соответственно. Проведенный анализ полученных результатов показывает возможность применения клеточного теста для сопоставления и количественной оценки активности аналогов эритропоэтина в международных единицах стандарта биологической активности (МЕ), принятых для эритропоэтина