BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Применение проточной цитометрии для оценки качества биомедицинских клеточных продуктов
Get PDFFlow cytometry is the most common method of identification and quantitation of cell surface markers. Flow cytometry can be used for cell counting and characterization of cell types and subtypes by labeling cells with fluorochrome-conjugated monoclonal antibodies. Manufacturers of human cell-based medicinal products have accumulated significant experience in flow cytometry and developed a large number of procedures that can be validated and included into cell products specifications. The present review summarises the experience gained with the use of flow cytometry for characterization of human cell lines used to develop cell therapy products. Since all biomedical cell products (BMCPs) have a cellular component, it will be necessary to use the flow cytometry method for identification testing of BMCPs during evaluation of their quality.Метод проточной цитометрии — наиболее информативный метод идентификации и количественного определения поверхностных маркеров клеток. Проточная цитометрия дает возможность проводить подсчет клеток, а также характеризацию их типов и подтипов путем мечения клеток моноклональными антителами, конъюгированными с флуорохромом. В настоящее время производителями продуктов на основе клеток человека накоплен значительный опыт применения проточной цитометрии, разработано большое количество методик, подлежащих валидации и включению в спецификацию на клеточный продукт. В обзоре авторами рассмотрен опыт применения метода проточной цитометрии для оценки качества клеточных линий человека, используемых, в частности, для создания препаратов с целью применения в клеточной терапии. Учитывая обязательное наличие клеточного компонента в составе биомедицинских клеточных продуктов (БМКП), метод проточной цитометрии будет являться обязательным при подтверждении подлинности в ходе экспертизы качества БМКП в Российской Федерации
Разработка и валидация методики определения концентрации экулизумаба в плазме крови человека с применением технологии биослойной интерферометрии
No full textThe article describes a new method for measurement of monoclonal antibody Eculizumab concentration in human plasma in a range of 3-250 μg/ml. In this method we used an antibody Fab fragment, capable of binding to eculizumab specifically in human plasma. The method uses the biolayer interferometry for determination of Eculizumab concentration without additional tag in the analyzing substances. This method was comparatively validated along with the traditional ELISA. Comparative validation demonstrated that the biolayer interferometry based method has an advantage to the ELISA in such important statistical criteria as an analytical range, accuracy, precision, specificity and selectivity (matrix effect).Разработана и валидирована методика определения концентрации препарата моноклонального терапевтического антитела экулизумаб в плазме крови человека в диапазоне концентраций 3-250 мкг/мл. Методика основана на взаимодействии иммобилизованного Fab-фрагмента антитела, специфичного к экулизумабу в образце плазмы крови. Методика использует принцип биослойной интерферометрии, позволяющий без внесения дополнительных меток оценить концентрацию анализируемого вещества. Результаты валидации методики сопоставлялись с результатами валидации альтернативной методики на основе иммуноферментного анализа. По итогам исследования показано преимущество методики на основе биослойной интерферометрии по основным метрологическим характеристикам - аналитическому диапазону, правильности, прецизионности и селективности
Экспериментальное исследование фармакодинамики моноклональных антител к α4β1-интегрину на морских свинках
No full textThis article presents the data on pharmacodynamics evaluation of monoclonal antibodies to α4β1-integrin in guinea pigs. The effect on total content of peripheral blood leukocytes after a single intraperitoneal injection of three doses of the drug has been studied. It was shown that intraperitoneal injection of the drug at doses of 30, 60, and 120 mg/kg causes a twofold increase in the content of leukocytes in the first hours after the administration, reaching a maximum value to 6th day. Subsequently 11-18 days, depending on dose, leukocytes content gradually decreased to control values.В статье представлен материал по оценке фармакодинамики моноклональных антител к α4β1-интегрину на морских свинках. Исследовано воздействие препарата на абсолютное содержание лейкоцитов периферической крови после однократного внутрибрюшинного введения в трех дозах. Показано, что внутрибрюшинное введение препарата в дозах 30, 60 и 120 мг/кг вызывает двукратное повышение содержания лейкоцитов уже в первые сутки после введения, достигая максимальных значений к 6 суткам. Впоследствии к 11-18 суткам, в зависимости от дозы препарата, содержание лейкоцитов постепенно снижается до контрольных значений
Использование наборов реагентов для ОТ-ПЦР в реальном времени для оценки подлинности вакцин против кори, паротита и краснухи
Get PDFCurrently, the identity of measles, mumps and rubella virus vaccines is determined during certification testing by a labour-consuming, lengthy and costly neutralisation test using cell cultures. The identity of the virus contained in such vaccines is established based on neutralisation of cytopathic effect of viruses in sensitive RK-13 and Vero cell cultures using a specific immune serum. An urgent challenge is to simplify and reduce the cost of controlling the identity of commercial batches of measles, mumps and rubella vaccines using polymerase chain reaction (PCR) tests. The aim of the study was to determine the possibility of viral ribonucleic acid (RNA) detection in these vaccines using reagent kits from different manufacturers for detection of measles, mumps and rubella viruses in clinical material by real-time reverse transcription-PCR (RT-PCR). The article presents the results of the study, which assessed the possibility of using the real-time RT-PCR for testing the identity of measles, mumps and rubella viruses in vaccines. The authors of the study analysed domestically produced and foreign reagent kits intended for detection of measles, mumps and rubella viruses in clinical material. All the studied reagent kits were able to detect RNAs of the above-mentioned viruses in vaccine products. All the reagent kits demonstrated high specificity and could be used to confirm the identity of the measles, mumps and rubella viruses in all the studied vaccines. Commercial domestic reagent kits can be used to determine the identity of rubella vaccines by RT-PCR. However, it is advisable to develop domestic reagent kits for checking the identity of measles and mumps vaccines by RT-PCR. The acceptability of the test results was assessed using the industry reference standards of measles, mumps and rubella viruses activity with certified stable activity values
Применение иммуноанализа для решения актуальных проблем стандартизации препаратов аллергенов
Get PDFThe present article describes principal problematic issues that refer to the standardization of allergen preparations. It is shown that at present domestic allergen preparations are being standardized by protein content in allergenic material, however, the mentioned characteristic does not reflect true allergic activity of a drug. There is a need in harmonization of domestic standardization technology for allergen preparations with the approaches of EMA (European Medicines Agency) and FDA (Food and Drug Administration), regulating their standardization in allergenic activity units, as well as the use of modern immunoassay methods for quantitative evaluation such as radioallergosorbent test, chemiluminescence analysis, immunoallergological test, enzyme-linked immunosorbent assay with inhibition phase etc
Новые антирабические рекомбинантные вакцины
No full textThe review covers problems of construction and production of new recombinant rabies vaccine. New approaches are being investigated to develop rabies vaccine and include methods of reverse genetic, production of virus antigens in plant cells cultures, obtaining of virus like particles and DNA and virus vector-based vaccines. Reverse genetics techniques let to manipulate the rabies genome and construct new attenuated strains of rabies virus. The production of the rabies virus main antigen (the glycoprotein G) in the plant cells cultures is promising for getting «edible» vaccines that do not require cleaning of antigen and repeated parenteral administration. Virus-like particles are capable to carry several rabies virus antigens, as well as different molecular adjuvants. DNA vaccines are characterized by ease preparation and low cost, but require different ways to enhance immunogenicity. Such approaches as DNA and virus vector-based vaccines delivering foreign genes, for example the gene of the glicoprotein G. Nowadays veterinary vaccines based on recombinant replication-competent vaccinia virus and human adenovirus type 5 are being actively used. Non-replicative human adenovirus type 5, expressing rabies glycoprotein G gene, is a good candidate for development of vaccines for mass immunization of the population