BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Теоретическое обоснование выбора субстанции интерферона альфа-2b для аттестации в качестве стандартного образца для оценки подлинности методом пептидного картирования
No full textThe article provides with the results of theoretical research on justification of the choice of methionine form of recombinant interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping. At present non- methionine and methionine forms of interferon alfa-2b substance are produced in Russia. The reference standard of interferon alfa-2b CRS I0320301, recommended by the European Pharmacopoeia, is a non- methionine standard and is suitable for identification test by peptide mapping only for a non- methionine form of a protein. In order to choose the reference standard candidate for methionine form of interferon alfa-2b, the article provides with the comparative analysis of the range of criteria and methods used by domestic manufacturers to confirm the quality of substances, authorized in the Russian Federation. The theoretical research allowed to choose interferon alfa-2b substance as a reference standard candidate for identification test by peptide mapping.В статье представлены результаты теоретических исследований по обоснованию выбора субстанции метиониновой формы рекомбинантного интерферона альфа-2b для аттестации в качестве стандартного образца при оценке подлинности методом пептидного картирования. В настоящее время в России производят как безметиониновые, так и метиониновые формы субстанций интерферонов альфа-2b. Рекомендованный Европейской фармакопеей референтный образец интерферона альфа-2b CRS I0320301 является безметиониновым и подходит для оценки подлинности методом пептидного картирования только безметиониновой формы белка. С целью выбора кандидата в стандартный образец метиониновой формы интерферона альфа-2b в статье проведен сравнительный анализ номенклатуры показателей и методов, используемых отечественными производителями для подтверждения качества субстанций, зарегистрированных в Российской Федерации. Проведенные теоретические исследования позволили выбрать субстанцию интерферона альфа-2b в качестве кандидата в стандартный образец для оценки подлинности методом пептидного картирования
Изучение диагностической значимости иммунореактивных эпитопов протеаз семейства Omptin с использованием пептидной библиотеки
No full textThe construction of highly sensitive new-generation diagnostic test systems requires the use of modern innovative technologies that are capable of detecting infectious agents at the molecular level by identifying specific antibodies to individual immunoreactive epitopes. The development of such immunoassays is based on molecular mapping of a target antigen using a library of short overlapping peptides aimed at identification of both epitopes specific for a particular pathogen, and those common to the group of infectious agents. The article describes new approaches that are based on the results of mapping of the Omptin group model protein that could be critical for improving retrospective laboratory diagnosis of infectious diseases caused by bacteria of the Enterobacteriaceae family. The article discusses the prospects for assessing the applicability of the peptide ELISA experimental version, designated as p6/24-Omptin-TIFA, for the detection of antibodies to diagnostically significant Omptin epitopes in the serum of people who have had enterobacterial infections, in order to introduce it into healthcare practices
Разработка и аттестация отраслевого стандартного образца активности филграстима
No full textThe article provides with the information on certification of an industrial reference standard (IRS) for determination of filgrastim activity. In order to confirm the quality of the IRS candidate, the following tests have been performed: biological activity, description, identification, clarity, colority, sterility, pH, foreign impurities, bacterial endotoxins, as well as the assay of: Filgrastim, Acetate ion, Polysorbate 80, residual Host Cell Proteins, residual Host Cell DNA. The results fully meet the requirements for filgrastim samples. The reference standard is certified for biological activity. The purpose of the IRS for determination of filgrastim activity is the assessment of acceptability of the results of biological activity tests in the quality control of substances and drugs based on filgrastim. Biological activity of the IRS candidate has been assessed by interlaboratory studies as compared against the second international standard NIBSC-09/136. The certified value for «Biological activity» of the IRS for determination of filgrastim activity has been set as 32.2±5.35 million IU/ml. The shelf-life under the storage conditions of 2 to 8oC has been set as not less than 2 years. The results of long-term stability studies the IRS confirm its stability during the monitored period
Определение вирусных нуклеиновых кислот в крови человека
Get PDFMany acute viral infections cause similar clinical symptoms, therefore, establishing the etiology of a viral disease requires the use of whole complexes of serological or PCR tests designed to detect a particular type of pathogen. Modern methods of molecular biology allow early diagnosis of viral diseases at a time when serological diagnostic methods are not yet effective. The aim of the work was to analyze molecular diagnostic methods that allow the determination of viral nucleic acids in human blood. The article presents the classification of molecular methods for the diagnosis of viral particles in clinical specimens. Methods such as in situ hybridization, reverse transcription reaction (RT-PCR), nested PCR, multiplex PCR, as well as DNA microarray technology, and the method of massive parallel sequencing are considered in detail. Particular attention is paid to NGS-technologies that were used in virology almost immediately after their appearance and allowed for detection of a number of new types of human viruses (including representatives of anelloviruses, picornaviruses, polyomaviruses, etc.). The advantages and problems associated with the application of these methods in clinical practice, as well as the prospects for their improvement are discussed
Международный опыт стандартизации препаратов аллергенов
No full textThe article demonstrates that safe and efficacious use of allergen products for detection and treatment of allergic diseases relies on standardization and quality control methods. The article summarises various approaches to allergen products standardization that are used in the United States, the European Union and the Russian Federation. Development of requirements for allergen products of natural origin must take account of the heterogeneity of raw materials used in their production, since native allergen extracts are complex protein-polysaccharide mixtures consisting of allergenic (primary and secondary) and non-allergenic components. Standardization of methods used for evaluation of allergen products potency is performed using reference standards. To date, there exist several approaches to allergens standardization. The United States introduced a system of national reference standards whose biological activity is determined by one technique (IntraDermal Dilution for 50 mm sum of Erythema determines bioequivalent Allergy Units - ID50EAL). In Europe each manufacturer establishes their own in-house reference standards (IHRS) and assigns them with units of activity. Products manufactured in the Russian Federation are standardized in protein nitrogen units (PNU)
Особенности определения специфической активности биотехнологических лекарственных средств
No full textThe review looks into various aspects of assessing specific activity of biotechnological products, which is one of their key quality parameters. Approaches to the analysis of this parameter and the choice of test procedures are governed by the nature and characteristics of a medicinal product. Test procedures should be adequate and have sufficient sensitivity and specificity. Specific activity of the products in question can be assessed by biological methods both in vivo using laboratory animals, which demonstrate the most adequate response to the tested product, and in vitro using sensitive cell lines. Assessment of specific biological activity helps to characterize the product’s pharmacological action and systematically examine the mechanisms of therapeutic effects in clinical practice. Therefore, specific activity of biotechnological products should be assessed using methods appropriate for the proposed mechanism of action. Many biotechnological products, such as cytokine system products, mAbs, fusion proteins and some others call for individual methods for assessment of their specific activity. Biotechnological products are successfully used in the treatment of autoimmune, infectious, oncological, and allergic diseases
Экстракт цикламена европейского (Cyclamen purpurascens) в качестве адъюванта при интраназальной иммунизации мышей гриппозными антигенами
No full textThe article describes the first attempt to use the juice and extract of Cyclamen europaeum (Cyclamen purpurascens) tubers as an adjuvant for intranasal immunization of mice with influenza antigens. The concentration of antigens used for immunization was 300 μg/ml for each subtype. The adjuvant was added at the concentration of 10 and 20 mg/ml. Blood serum was studied using the hemagglutination inhibition reaction (HI) and enzyme immunoassay (ELISA). After two immunizations with a dose of 7.5 μg, the maximum inverse titers to the H1/H3/B components in the HI were 320/80/80, respectively. The administration of an intranasal comparator without an adjuvant did not result in seroconversion which can be detected by the HI. The analysis of the blood sera of mice, immunized intranasally by the antigen only, showed no increase in the antibody levels between the first and second injections. For mice immunized intranasally by a preparation containing 10 mg/ml (0.5 mg per 50 μl dose) of adjuvant the ELISA detected a significant growth of antibody levels for all components, and GMT antibody levels were comparable to GMT antibody levels after a single intramuscular injection of 5 μg of each antigen. Despite a significant serum titer dispersion (which the authors explain by the impossibility of ensuring absolute uniformity in administration of 50 μl of substance via the nasal route) the use of the extract as an adjuvant for intranasal immunization of mice with highly concentrated influenza antigens showed a significant humoral response. The level of this response after two immunizations in some animals was comparable to that after intramuscular administration. The obtained data open the possibility of using Cyclamen europaeum tuber extract or its chemical analogues in further studies in guinea pigs, ferrets or other animal models in order to develop an efficacious adjuvant for intranasal immunization
V Всероссийская научно-практическая конференция с международным участием «Актуальные вопросы профилактики, диагностики и лечения туберкулеза у детей и подростков» совместно с заседанием профильной комиссии по специальности «Фтизиатрия» при главном внештатном детском специалисте фтизиатре
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Разработка и валидация методики определения невидимых механических включений в воде для инъекций с применением метода Култера (электрочувствительных зон)
Get PDFWater for injections is one of the most popular diluents used for preparation of parenteral dosage forms. The European Pharmacopoeia recommends two methods for the determination of subvisible particulate matter: Light Obscuration Particle Count Test and Microscopic Particle Count Test. The Russian Pharmacopoeia, 13th ed., additionally allows for the use of the Coulter principle (Electrical Sensing Zone method). Thus, a procedure had to be developed for subvisible particles determination in water for injections based on the Coulter principle (hereinafter — procedure). The article presents the results of development and validation of the procedure, i.e. the characteristics of accuracy, dilutional linearity, ruggedness in terms of the time factor, and repeatability for particles more than 10 μm in size. The results of subvisible particles determination obtained with the help of the developed procedure based on the Coulter principle were compared to the results obtained with the help of the light obscuration particle count test. The accuracy of the developed procedure was supported by the statistical insignificance of the differences between the obtained results. The values of ruggedness in terms of the time factor (NMT 14 %) and repeatability (NMT 15 %) did not exceed the established acceptance criterion which is equal to the acceptable limit of the instrument error for particle count in the tested samples (20 %). The dilutional linearity of the procedure was demonstrated (coefficient of determination R2 = 0.999). The results obtained during the validation studies support the possibility of using the Coulter principle for the assessment of subvisible particles in water for injections