BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
Not a member yet
340 research outputs found
Sort by
Разработка подходов к проведению испытания гетерологичных сывороточных препаратов по показателю «Стерильность» методом мембранной фильтрации
No full textReliable evaluation of blood products sterility is a very important and one of the most complex and critical control methods in the context of microbiological safety. The membrane filtration method that uses a closed-circuit system has, for many years, been the main and the most preferable sterility test method for all known medicinal products. However, Russian manufacturers perform sterility testing of heterologous serum products by direct inoculation method only. The present study was aimed at exploring the feasibility of performing sterility testing of heterologous serum products by membrane filtration. It was shown that sample preparation could be modified by dilution of samples to, on average, 1.5-2 times the initial volume with a sterile 0.9 % sodium chloride solution followed by membrane filtration at a geared-up rate which lowers protein sorption by the membrane filter. The study helped to determine the range of protein impact on the membrane when testing serum products according to the State Pharmacopoeia 13th ed. It was shown that various types of filter elements from mixed cellulose esters and Durapore® (PVDF) could be used to test serum products by membrane filtration with a protein impact range of up to 12 g of protein per membrane. The results of heterologous serum products sterility testing by direct inoculation method and by membrane filtration were found to be comparable. Adaptation of the procedure to protein-containing products makes it possible to perform sterility testing by a more reliable and modern method. The authors can recommend the incorporation of the above-cited test procedure into quality standards for products concerned together with the currently used direct inoculation method
Перспективы совершенствования экспертизы качества вакцины туляремийной живой
No full textThe article presents prospects for improving the evaluation of live tularemia vaccine (hereinafter - tularemia vaccine) quality in terms of the following parameters: «Identification», «Specific activity (the number of living microbial cells)» and the «Absence of extraneous microorganisms and fungi». The authors investigated the possibility of improving evaluation of tularemia vaccine quality as regards the «Identification» parameter by using a commercial diagnostic test kit - immunochromatographic test system for express detection and identification of tularemia agent («F. tularensis ICA test system»). In order to optimize and improve the evaluation of tularemia vaccine quality as regards «Specific activity (the number of living microbial cells)» parameter it is recommended to use a ready-to-use growth medium for cultivation and isolation of tularemia microbe - as an additional culture medium for determination of the number of living microbial cells. It is proposed to improve the methodology of tularemia vaccine quality evaluation as regards the «Absence of foreign microorganisms and fungi» parameter by eliminating the stage of subculturing material in thioglycollate medium for 5-7 days, which is reasonable from economic and practical points of view and also reduces the risk of false positive results
Современное состояние лабораторной диагностики сибирской язвы: обнаружение и идентификация Bacillus anthracis
No full textThe present article summarizes the materials from literary sources dedicated to the issues of laboratory diagnosis of anthrax. It shows the priority of the development of new methods for the elaboration of highly sensitive test systems and preparations designed for the detection and identification of anthrax bacteria. It outlines the role of express-diagnostics of infectious diseases, which is very important when investigating bioterrorism cases, outbreaks and sporadic cases in humans and animals. Providing with the analysis of different methods for detection of anthrax, the article at the same time focuses on modern molecular diagnostic technologies. It is shown that the basic parameters of diagnostic test systems are sensitivity, specificity and reproducibility of the results. The article presents data on the development of culture media for isolation and identification of anthrax, as well as the possibility of using anthrax bacteriophage for phage-based indication and identification of bacteria.В статье обобщены материалы источников литературы, посвященные вопросам лабораторной диагностики сибирской язвы. Показана приоритетность разработки новых методов создания высокочувствительных тест-систем и препаратов, предназначенных для обнаружения и идентификации сибиреязвенного микроба. Отмечена роль экспресс-методов для обнаружения возбудителей инфекционных болезней, что имеет большое значение при расследовании актов биотерроризма, спорадических случаев и вспышек среди людей и животных. Приводится анализ использования различных методов выявления возбудителя сибирской язвы, при этом акцентируется внимание на современных молекулярно-диагностических технологиях. Показано, что основными параметрами диагностических тест-систем являются их чувствительность, специфичность, а также воспроизводимость получаемых результатов. В статье приводятся данные о разработках питательных сред для выделения и идентификации возбудителя сибирской язвы, а также о возможности использования сибиреязвенных бактериофагов для фагоиндикации и фагоидентификации бактерий
Разработка процесса непрерывного культивирования клеток CHO - продуцентов рекомбинантного фактора свертываемости крови VIII
Get PDFPerfusion cultivation process for CHO cells producing recombinant B-domen deleted coagulation factor VIII was developed. Cell culture medium and feed supplement were optimized by screening of big panel of prototype media and supplements. Cultivation temperature was optimized for better expression of complex protein as well. Cultivation process was tested in a laboratory-scale perfusion bioreactor. Significant increase of productivity was shown as a result of the development.Проведена разработка процесса перфузионного культивирования продуцента рекомбинантного фактора свертываемости крови VIII, созданного на основе клеток яичников китайского хомячка (СНО). Оптимизирован состав питательной среды, а также температура культивирования продуцента. Осуществлена апробация процесса культивирования в лабораторном биореакторе волнового типа. Показано значительное увеличение выхода активного белка в результате проведенной разработки
Менингококковая инфекция. Полисахаридные менингококковые вакцины. Исторические аспекты и современное состояние разработок. Сообщение 2
Get PDFThe present article describes clinical signs of meningococcal disease. It justifies the necessity of its vaccine prevention. The article provides with the historical data on the evolution of inoculants from corpuscular inactivated vaccines to modern chemical polyvalent vaccines. It provides a glimpse of the efficacy of the use of corpuscular vaccines and considers the corresponding implications. The historical overview includes the use of mono-, di-, tetravalent polysaccharide vaccines, and the discussion on the role of bactericidal antibodies in the formation of immunity against meningococcal disease. The article also describes the experience of using polysaccharide vaccines in various countries and in different age groups in randomized clinical trials. It provides with the data analysis about the effect of vaccination on the level of meningococcal carriage and the incidence of meningococcal disease. The WHO’s position on the use of polysaccharide meningococcal vaccines in routine practice are also provided. In the conclusion the article presents the prospects for further use of polysaccharide vaccines to control the spread of meningococcal disease
Менингококковая инфекция. Конъюгированные полисахаридные менингококковые вакцины и вакцины нового поколения. Сообщение 3
No full textПодходы к фармацевтическому анализу современных пептидных и олигонуклеотидных препаратов на примере инновационного препарата на основе малой интерферирующей РНК для лечения бронхиальной астмы
Get PDFMethods used to control the quality of peptide products depend on the level of development of analytical and bioorganic chemistry, and the level of instrumentation. Peptide identification is a difficult task and largely depends on the complexity of its structure. There does not exist a comprehensive and simple test, except for NMR, which, however, is rather expensive and time-consuming and involves complex data interpretations. Moreover, it does not allow for unambiguous determination of the peptide purity and formula (amino acid composition, sequence, chirality of amino acid residues). For this reason, a combination of methods is often used, including amino acid analysis, TLC/HPLC and mass spectrometry, and, less frequently, sequencing. Current international practice of peptide analysis is to use HPLC in combination with mass spectrometric, mainly tandem (HPLC-MS/MS), detection. According to literature sources the amino acid sequence of linear peptides can be analysed using various enzymes and subsequent identification of proteolysis products by mass spectrometry. This article presents approaches to the development of test methods for analysis of purity and identification testing of a small interfering RNA-based novel medicinal product, which will help standardise and control the quality of the production process
История разработки фармакопейных стандартов качества на биологические лекарственные препараты и методы испытаний в России
No full textThe Russian system of standardization of HP including biological medicines is based on the State Pharmacopoeia of the Russian Federation numbering more than the 250th summer history of the development. Requirements of general the farmakopoeia and the farmakopoeia of articles included in the State Pharmacopoeia of the Russian Federation are obligatory for all organizations which are engaged in the territory of the Russian Federation in production, production, quality control, storage and use of medicines. Historical development the farmakopoeia of the quality standards on biological medicines is reflected in article, starting with the first publications of articles editions (1910) and to GF Programme of the Russian Federation editions (2015) in which are provided are included in GF VI of Russia 57 OFS and 56 FS on the biological medicines allowing to provide standardization of requirements to their quality. Further enhancement and development of various directions in the immunobiology, immunobiological technologies which are based on a joint of immunology and molecular biology, and also genetic engineering and as a result of it, development of new BLP requires further development and the standardization of these HP guaranteeing their quality at all stages of lifecycle