BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Этапы стандартизации препаратов эритропоэтинов
Get PDFPreparations of recombinant human erythropoietin (rhEPO) are included in the list of vital and essential drugs for medical use. When evaluating the quality of EPO preparations during the manufacturing process, under the state marketing authorization and certification procedures, in order to confirm their quality in terms of assay (specific activity), identification, dimer and high-molecular related substances content, sialic acids, it is required to use erythropoietin reference standard. The present article describes various stages of the development of erythropoietin reference standards. It provides the comparative description of the existing methods for evaluating the quality of erythropoietin preparations using reference standards. The necessity of the development and validation of national erythropoietin reference standard is justified.Препараты рекомбинантных эритропоэтинов человека (рчЭПО) входят в перечень жизненно необходимых и важнейших лекарственных препаратов для медицинского применения. При оценке качества препаратов ЭПО в процессе производства, при государственной регистрации и сертификации для подтверждения их качества по таким показателям, как количественное определение (специфическая активность), подлинность, димеры и высокомолекулярные родственные вещества, сиаловые кислоты, необходимы стандартные образцы эритропоэтина. В работе приведены сведения об этапах разработки различных стандартных образцов эритропоэтина. Дано сравнительное описание существующих методов оценки качества препаратов эритропоэтина с использованием стандартных образцов. Показана необходимость разработки и аттестации отечественного стандартного образца эритропоэтина
Валидация метода определения содержания активатора прекалликреина в препарате Альбумин человека
No full textPrekallikrein activator (PKA) is regarded as one of the most important factors determining the safety of blood products such as albumin and intravenous immunoglobulin. PKA impurity at a high concentration may cause undesired side effects when administered to patients of blood products. According to requirements of the State Pharmacopoeia of the Russian Federation (13th edition) human albumin preparations have to pass test for the quantitative determination of prekallikrein activator (PKA), but there is no description of the method. The purpose of this study consisted in validation of a method of the quantitative definition of PKA in the preparations Albumin (human albumin) solution for infusions 10 % and 20 % with use of the commercial kit PreKallikrein Activator Assay Kit PW301EP («Pathway Diagnostics Ltd», UK). It is established that the method is accurate, linear, high-precision and specific. The method is characterized by the simplicity of the experiment, high accuracy and reproducibility that can be used in terms of control and analytical laboratories. It is shown that in all investigated batches of the drug Albumin (human albumin) solution for infusion 10 % and 20 % PKA content was less than 1 IU/ml, which corresponds to the requirements of the State Pharmacopoeia of the Russian Federation to these drugs
Аттестация новой серии отраслевого стандартного образца содержания полисахарида в вакцине Шигеллвак
Get PDFThe article summarises materials on the certification of the industry reference standard of Schigella sonnei polysaccharide dysentery vaccine (commercial name — Schigellvac). The industry reference standard is used to assess the consistency of the vaccine «Specific activity» testing by passive hemagglutination inhibition assay. A certification programme for the industry reference standard was developed. Samples of the candidate vaccine were tested in terms of the following quality characteristics: «Appearance», «Identification», «Extractable Volume». The test results confirmed that the samples comply with the current requirements of the manufacturer’s product specification file for Schigellvac vaccine. It was determined that the certification parameter — the polysaccharide dilution ratio which results in inhibition of passive hemagglutination in a homologous system — has to fall in the range from 1:128 to 1:512. The following set of standard documents accompanying a scientific/technological product was approved for the industry reference standard No. 42-28-386-2017: passport, patient information leaflet, mockup labels for primary and secondary packaging.В статье представлены материалы по аттестации отраслевого стандартного образца (ОСО) вакцины дизентерийной против шигелл Зонне полисахаридной, торговое наименование «Шигеллвак», предназначенного для оценки стабильности проведения испытаний данного лекарственного препарата по показателю «Специфическая активность», определяемому в реакции торможения пассивной гемагглютинации. Разработана программа аттестации ОСО. Образцы вакцины — кандидата в ОСО были испытаны по показателям: «Описание», «Подлинность», «Извлекаемый объем». Результаты испытаний подтвердили их соответствие требованиям действующей фармакопейной статьи предприятия на вакцину Шигеллвак. Определена аттестуемая характеристика: разведение полисахарида, при котором наблюдается торможение реакции пассивной гемагглютинации в гомологичной системе, должно находиться в диапазоне от 1:128 до 1:512. Утвержден пакет нормативных документов на научно-техническую продукцию ОСО 42-28- 386-2017: паспорт, инструкция по применению, макеты этикеток первичной и вторичной упаковок
Изучение возможности использования метода qPCR для контроля отсутствия микоплазменной контаминации в клеточных культурах
No full textMycoplasmas are the main contaminants of cells cultures. They persist in cell cultures and can extensively affect host cell functions. Conducting experiments or producing protein in contaminated cultures are impractical. The aim of the study was to explore the possibility of quick detection of mycoplasma contamination of cell cultures and biotechnological products by a previously developed method which was modified to make it simpler and more affordable in Russia; and to assess the possibility of method validation for quality control. The authors chose the most applicable qPCR method of all qPCR methods currently used for mycoplasma detection, and modified it in the following way: expensive MGB-probes which cannot be synthesized in Russia were substituted by ordinary fluorescence probes. The reproducibility and sensitivity of the modified method were tested with M. hominis. The sensitivity of the test was equal to 10 mycoplasma gene copies per reaction. Comparison of the obtained results with regulatory requirements for mycoplasma detection showed that the proposed method complies with current official requirements and could be used as the main method for routine prompt cell culture testing for mycoplasma contamination
Редактирование генома и биомедицинские клеточные продукты: современное состояние, безопасность и эффективность
Get PDFAdvances in ex vivo technologies of human genome editing have made it possible to develop new approaches to the treatment of genetic, oncological, infectious and other diseases, which may involve the use of biomedical cell products. However, despite the rapid development of these technologies and a large number of clinical trials conducted in many countries around the world, only 4 products (Strimvelis, Zalmoxis, Kymriah and Yescarta) containing ex vivo genetically modified human cells are authorised for use in the European Union and the United States of America. This paper considers three promising technologies (ZFN, TALEN and CRISPR) that allow for easy and effective editing of the genome at the sites of interest, thereby creating a platform for further development of the genetic engineering of human cells. It describes the technology of engineering chimeric antigen receptors (CARs). It also provides data on the efficacy and safety of the approved products: Strimvelis which contains autologous CD34+ cells transduced ex vivo with a retroviral vector containing adenosine deaminase gene, Zalmoxis which contains modified allogeneic T-cells, and two products: Kymriah and Yescarta which contain autologous T-cells with CARs to CD19 antigen, intended for the treatment of CD19+ hematological malignancies
Эффективность и безопасность вакцин для профилактики холеры
Get PDFCholera is an acute diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and O139 serogroups. It still remains a major global healthcare problem. According to WHO, about 100,000 people die from cholera every year, despite the modern methods of treatment, improvement in the quality of drinking water, sanitation and hygiene. In recent years, oral cholera vaccines have proved an effective tool for preventing and curbing cholera epidemics. According to the WHO Ending Cholera — A Global Roadmap, mass vaccination should help reduce the mortality resulting from cholera by 90 % worldwide by 2030 and eliminate the disease in 20 countries. The review outlines the main historical stages in the development of cholera vaccines: parenteral, chemical, inactivated and live oral vaccines. The paper compares active ingredients and excipients used in Dukoral®, mORC-VAX®, Shanchol®, Euvichol®, Vaxchora®, Oravacs® and the cholera bivalent chemical vaccine. The results of international multicenter clinical trials of oral inactivated, live and chemical cholera vaccines are analysed. Issues related to efficacy and safety studies of cholera vaccines are considered
Влияние сока подорожника на проявления и исход острой интоксикации циклофосфаному крыс
Get PDFTo estimate the influence of the plantain juice on neurological manifestations of the severe acute cyclophosphamide intoxication, rats have been gavaged with 4 ml/kg plantain juice 1 h before cyclophosphamide dosing (intraperitoneally, 600 mg/kg). Within 3 h after cyclophosphamide administration, rats’ blood ammonia, glutamine and urea was increased. These alterations have been attenuated with the prophylactic administration of the plantain juice. At the background of the administration of the plantain juice the hypodynamia was less pronounced, duration of life has increased. Therefore, experimentally has been demonstrated the potency of the plantain juice usage for prophylaxis of hyperammonaemic and neurotoxic action of cyclophosphamide.Для оценки влияния сока подорожника на обмен аммиака и неврологические проявления острого тяжелого отравления циклофосфамидом крысам внутрижелудочно вводили сок подорожника в дозе 4 мл/кг за 1 ч до инъекции циклофосфамида (внутрибрюшинно, 600 мг/кг). Через 3 ч после введения циклофосфамида в крови крыс были повышены уровни аммиака, глутамина и мочевины. Эти изменения были частично коррегированы профилактическим применением сока подорожника. На фоне введения сока подорожника гиподинамия у отравленных животных была менее выражена, продолжительность жизни увеличивалась. Таким образом, экспериментально показана возможность использования сока подорожника для коррекции гипераммониемического и нейротоксического действия циклофосфамида
