BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Исследование фармакодинамики препарата на основе терапевтических гуманизированных моноклональных антител против интерлейкина-17 на модели антиген-индуцированного артрита на кроликах
No full textThe present article contains scientific data on the assessment of specific activity of therapeutic humanized monoclonal antibodies against IL-17 in rabbit model of antigen-induced arthritis. Pharmacokinetics and immunogenicity of anti-IL-17A preparation have been studied. The severity of rheumatoid arthritis progression has been assessed by the levels of joint damage, the levels of inflammatory markers and according to Menkin histological grade.В настоящей статье представлен материал по оценке специфического действия препарата терапевтических гуманизированных моноклональных антител против интерлейкина-17 на модели антиген-индуцированного артрита на кроликах. Исследована фармакокинетика и иммуногенность препарата анти-IL-17A. Тяжесть развития артрита оценивали по степени повреждения суставов, уровню маркеров воспаления и гистологической шкале Мэнкина
Влияние рекомбинантного интерферона альфа-2b на относительное содержание CD56bright-популяции натуральных киллеров в периферической крови беременных женщин с урогенитальными инфекциями
No full textPhysiological immunodeficiency during pregnancy contributes to activation of chronic urogenital pathology which often causes intrauterine infections. Recombinant interferon-alpha based rectal suppositories VIFERON® are often used in Russia for treatment of pregnant women with urogenital pathology. The treatment results in a marked decrease in the number of pregnancy complications and perinatal pathology accompanied by a decrease in peripheral blood CD56bright natural killer cells.Ослабление неспецифической резистентности организма во время беременности сопровождается активацией хронических урогенитальных инфекций, которые являются частой причиной внутриутробного инфицирования плода. В российской акушерско-гинекологической практике в комплексе дородовой подготовки беременных с урогенитальными инфекциями применяется препарат на основе рекомбинантного интерферона альфа-2b ВИФЕРОН® в лекарственной форме «суппозитории ректальные». Благоприятный клинический эффект препарата на течение беременности и перинатальный исход сопровождается снижением относительного содержания CD56bright-популяции натуральных киллеров в периферической крови исследованных беременных женщин
Проблемы оценки неопределенности методик испытаний и стандартных образцов иммунобиологических лекарственных средств
No full textThe article summarises the results of analysis of guidelines and regulations as well as experience in validation of analytical methods and certification of reference standards (RS) of biological medicinal products. Based on the results of the analysis the authors propose an approach to estimation of test methods and reference standards uncertainty to determine biologicals quality parameters in the context of intermediate precision/reproducibility. Expanded uncertainty of the test method was estimated as 2 standard deviations of the test results in the context of intermediate precision/reproducibility for the predetermined range of the tested parameters, and the uncertainty of the reference standards - as 2 standard deviations of the test results for the reference standards in the context of intermediate precision/reproducibility. Since reference standards for most biologicals are currently tested by the same method by which they were certified, an analytical system (a reference standard and a test method) is used as a means of measurement units representation
Безопасность биологических препаратов. Сообщение 2. Проблемы безопасности биоподобных препаратов
No full textМеждународный опыт нормативно-правового регулирования препаратов, содержащих жизнеспособные клетки человека
Get PDFThe intensive development of cellular technologies stipulates the introduction at the global level of medicinal products based on viable human cells, which in most countries are referred to as biomedical cell products. The authors conducted a comparative analysis of the regulatory framework in different countries and determined special aspects of regulation of cell therapy products (analogues of biomedical cell products). Some countries have mechanisms for priority review of cell therapy products for marketing authorization, such as accelerated assessment, accelerated approval, or conditional marketing authorisation. These mechanisms are currently absent in Russia, because of the novelty of the regulatory framework, and the biological properties of innovative cell products. Biomedical cell products are regarded as a separate class of medicinal products in Russia, they are not treated as biologicals and are regulated by the Federal Law No. 180-FZ «On Biomedical Cell Products» of June 23, 2016. The main difference in regulation of cell-based products in the Russian Federation is the principle of unified requirements for marketing authorisation of autologous, allogeneic, and combined biomedical cellular products, and the absence of the «hospital exemptions» mechanism that exists in many countries. This mechanism allows prescription and use of personalised autologous medicines produced in the laboratory of a medical institution for a particular patient
Национальная стратегия Российской Федерации по предупреждению распространения устойчивости патогенных микроорганизмов к антимикробным препаратам: трудности и перспективы сдерживания одной из глобальных биологических угроз XXI века
Get PDFMicroorganism resistance to medicinal products and disinfectants reduces the efficacy of prevention and treatment of human infectious diseases, increases the severity and duration of such diseases as well as the mortality rates, and is therefore regarded as a major global health issue. With a view to implementing the Russian National Security Strategy and the Principles of the National Policy in the Sphere of Chemical and Biological Safety of the Russian Federation up to 2025 and beyond, and with due regard to the Concept of the Long-Term Social and Economic Development of the Russian Federation until 2030 — the Government of the Russian Federation issued a resolution (in 2017) that approved the Strategy for Prevention and Combating the Resistance of Microorganisms and Plant Pests to Medicinal Products, Chemical and Biological Agents up to 2030 and beyond (hereinafter — Strategy). The Strategy is a federal document that defines the aim and objectives of controlling the biological threat coming from the spread of microorganism and plant pest resistance to medicines, chemical and biological agents. The article analyses the aim and objectives of the Strategy, dwells upon specific features of the document, summarises the main stages and expected results of measures outlined in the document, and describes some aspects of its implementation
Оценка стабильности производства коклюшного компонента АКДС-вакцины по показателям иммуногенной активности и специфической безопасности с использованием карт Шухарта
Get PDFWHO experts attribute the resurgence of whooping cough to the wide use of acellular pertussis vaccines (aPs) as components of combination products. In this regard, WHO encourages countries that have not yet switched to the use of aPs to continue to use whole-cell pertussis vaccines (wPs) for primary vaccination. The experience of using pertussis vaccines has shown that companies do not always produce highly efficacious products. The use of statistical methods of samples quality control helps to ensure consistency of the technological process, which results in the production of more homogeneous products, and rules out the possibility of producing low-quality products. This paper presents the results of retrospective evaluation of the consistency of the wP (as a pertussis component of the DTP vaccine) production using Shewhart control charts. It was shown that at some points in time during the analyzed period from January 2017 until March 2018 the technological process of the company lacked proper statistical control. This increased the risk of producing non-uniform and defective products. In order to improve the quality and consistency of pertussis component batches, the company’s quality control and quality assurance services should make extensive use of Shewhart charts on a real-time basis
Изучение возможности увеличения срока годности стандартного образца иммуноглобулина человека для определения антикомплементарной активности
No full textThe article gives an account of the stability study performed for two batches of human immunoglobulin reference standard (RS) used for determination of anticomplementary activity (industry reference standard, IRS 42-28-430). The first batch of human immunoglobulin reference standard used for determination of anticomplementary activity showed sustainable results during 30 months of storage at (5±3) °C which makes it possible to extend the RS shelf life from 18 months (corresponding to the initial monitoring period) to 30 months from the date of determining the certified parameter, given the acceptable range of more than 50 % for the positive control and less than 50 % for the negative control. Based on the results obtained, the re-certification was performed for the second RS batch after 18 months of storage. The main certified parameter (anticomplementary activity) of the negative control was within the range of 41.6±7.2 %, and of the positive control 75.7±6.8 % for the confidence level of 0.95. Therefore, the shelf life of the second batch of the human immunoglobulin reference standard used for determination of anticomplementary activity (IRS 42-28-430) was extended until February 2018, which makes 30 months
Получение рекомбинантного слитого белка OprF-aTox Pseudomonas aeruginosa, обладающего защитными свойствами
No full textInto the cells of Escherichia coli (strain BL21(DE3)) two forms of the fusion protein Pseudomonas aeruginosa containing the full length outer membrane protein F (OprF) and nontoxic form of Exotoxin A (without 106 C-terminal amino acid residues) have been synthesized. Two recombinant genes were inserted into plasmid pET28 in different order: oprF-atox and atox-oprF. Only oprF-atox variant allowed to obtain the recombinant protein sufficient for purification by affinity chromatography on Ni-Sepharose. The recombinant fusion protein OprF-aTox showed a high specificity in interaction with the preparations of polyclonal immune rabbit serum to the recombinant OprF, the recombinant nontoxic form of Exotoxin A and the bacterial cells of P. aeruginosa. The purified recombinant fusion protein OprF-aTox after two immunizations protected the mice against toxigenic strain of P. aeruginosa (РА-103) being injected intraperitoneally. The index of efficiency of protective properties of OprF-aTox in the optimal dose (50 µg protein per mouse) was 3.5. This was more efficient than in cases when the recombinant OprF and the recombinant toxoid were injected separately. The indexes of efficiency of protective properties of OprF and the toxoid were 2.1 and 2.0.Получен рекомбинантный слитый белок OprF-аТох, который содержал последовательности белка F наружной мембраны (OprF) и дефектной формы экзотоксина А Pseudomonas aeruginosa. Этот рекомбинантный белок был синтезирован в клетках Escherichia coli и очищен с помощью никель-сефарозы. Показано, что слитый рекомбинантный белок OprF-аТох при иммунизации обладал защитными свойствами от инфекции, вызываемой вирулентной токсигенной культурой Pseudomonas aeruginosa штамма РА-103