BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Методические подходы к доклинической оценке побочного действия сывороточных иммунобиологических лекарственных препаратов
No full textAnalysis of methodological approaches to preclinical evaluation of sensitizing activity of horse serum products shows that the anaphylactogenicity scale recommended in national regulatory documents is imperfect as it is not capable of fully predicting the safety of the clinical use of products. The article demonstrates feasibility of another methodological approach to preclinical evaluation of sensitizing activity of heterologous serum products which is based on calculation of a sensitizing dose inducing anaphylactic reactions in 50 % of guinea pigs. This approach will make it possible to more effectively predict side effects of already authorized heterologous immunoglobulins and drugs currently under development, and to select a clinical use strategy on a case-by-case basis.Анализ методических подходов к доклиническому изучению сенсибилизирующей активности иммунобиологических препаратов из сыворотки крови лошадей показывает, что национальные руководящие документы рекомендуют использование ограниченной шкалы анафилактогенности, которая не позволяет в полной мере прогнозировать безопасность клинического применения препаратов. Обоснован другой методический подход к доклинической оценке сенсибилизирующей активности сывороточных гетерологичных иммунобиологических препаратов по расчету сенсибилизирующей дозы, вызывающей анафилактическую реакцию у 50 % морских свинок, что позволит более объективно прогнозировать побочное действие как уже существующих, так и разрабатываемых гетерологичных иммуноглобулинов, а также индивидуально выбирать тактику их клинического применения
Фармакокинетические свойства препаратов белковой природы
Get PDFBiological preparations differ substantially from low molecular weight chemicals in molecular weight, multidimensional structure of an active substance, presence of post-translational modifications, composition of impurities and excipients, drug manufacturing process, etc. These specific features of biological preparations also influence their pharmacokinetic properties. The assessment of pharmacokinetic properties is essential not only for the confirmation of the efficacy of a biological preparation, but it is also key aspect of demonstrating the similarity/analogy of a biosimilar preparation under development and the reference (original) preparation. High molecular weight biological preparations when administered subcutaneously and intramusculary initially migrate from the injection site into lymphatic vessels and then to blood. Pharmacokinetic properties of drugs with Fc region of immunoglobulin, are affected by their ability to interact with Fcy and FcRn receptors. Almost all biological preparations possess immunogenicity, the appearance of antibodies to a drug causes changes not only in pharmacodynamic but also in pharmacokinetic properties of biological products. The assessment of pharmacokinetic properties is a complicated and time-consuming process, for example, the study of drug distribution may in some cases require the use of a radioactive label
Первые биоподобные лекарственные препараты моноклональных антител
No full textoai:oai.biopreparat.elpub.ru:article/67The review deals with the issues related to the special aspects of the development of the first available similar biopharmaceuticals/biological analogues («biosimilars») based on monoclonal antibodies. In June 2013 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved for licensing Remsima and Inflectra which are biosimilars of the brand-name product Remicade® (infliximab). The review describes the general principles of the development of the mentioned biosimilars. It highlights the features of the quality assessment studies, including characterization of the physical and chemical properties, specific biological activity, as well as comparative preclinical and clinical trials confirming the similarity of the candidate and the brand-name (reference) product. The review provides with the analysis of the results of comparative studies to assess the clinical relevance of the differences detected at the stage of quality assessment. The data substantiating the possibility of extrapolating the results obtained in clinical trials, against the approved standards for the brand-name product is provided
Аттестация и продление срока годности новой серии отраслевого стандартного образца специфической активности и иммуногенности вакцины туляремийной живой
Get PDFThe article presents the results obtained in the study of a new batch of a candidate branch reference standard for live tularemic vaccine (vaccine BRS). The candidate vaccine BRS was represented by a commercial batch of a product that met all applicable requirements of the manufacturer’s monograph (MM) for live tularemic vaccine’s quality attributes. The candidate vaccine BRS was certified for specific activity including a range of parameters, such as: microbial cells concentration, percentage of living microbial cells, dissociation degree (percent of SR (white) immunogenic colonies from the total number of colonies grown), as well as immunogenicity. Results of analysis that addressed the use of this batch of vaccine BRS and its quality attributes made it possible to extend the shelf-life of the product for 6 months.В статье представлены результаты по изучению новой серии кандидата в отраслевой стандартный образец вакцины туляремийной живой (ОСО вакцины). В качестве кандидата в ОСО вакцины, использовали коммерческую серию препарата, удовлетворяющую требованиям фармакопейной статьи предприятия (ФСП) по всем показателям качества, предъявляемым к вакцине туляремийной живой. Кандидат в ОСО вакцины аттестован по показателю специфическая активность, включающей в себя комплекс показателей: концентрация микробных клеток, процент живых микробных клеток, степень диссоциации (процент SR (белых) иммуногенных колоний от общего количества выросших), а также иммуногенность. На основании анализа результатов применения и оценки показателей качества данной серии ОСО вакцины продлен срок годности ОСО на 6 мес
Анализ стабильности показателей качества биологических лекарственных препаратов при проведении испытаний в рамках подтверждения соответствия
No full textThe statistical analysis of trends in the quantitative data obtained during laboratory evaluation is one of the most important conditions of ensuring quality. Equally, the analysis of trends is necessary to confirm the compliance of biological medicinal products to the requirements of manufacturers’ quality standards and to ensure the reliability of laboratory tests. The article briefly surveys the positions of the World Health Organization (WHO) and the International Organization for Standardization (ISO) on the analysis of trends in the production of biological medicinal products, especially vaccines, as well as on methodological approaches to the planning and organization of random sampling checks.Статистический анализ закономерностей количественных данных, получаемых в результате лабораторной экспертизы, является одним из важнейших элементов обеспечения качества. В равной степени анализ трендов необходим при подтверждении соответствия биологических лекарственных препаратов требованиям нормативной документации и для обеспечения достоверности лабораторных испытаний. В статье кратко рассмотрены позиции Всемирной организации здравоохранения и Международной организации по стандартизации по вопросам анализа трендов при выпуске биологических препаратов, в частности, вакцин, а также методическим подходам к планированию и организации процедуры выборочного контроля
Эпидемиология гепатита А и тактика вакцинопрофилактики
Get PDFHepatitis A (HA) is an acute infectious disease of the liver caused by the hepatitis A virus (HAV). HA disease incidence rate is closely linked to the social and economical development. The results of seroepidemiologic studies show that the prevalence of anti-HAV antibodies in population ranges from 15 to almost 100% in various countries of the world. The only reliable way to prevent hepatitis A virus (HAV) for today is the specific prophylactic vaccination. Recently developed inactivated vaccines against HAV have been successfully used in many countries. Vaccines authorized in Russia are safe, possess low reactogenicity and high immunogenicity. Practical experience in using vaccines during the outbreaks of HAV has shown that they possess epidemiological efficacy and provide necessary protection of the population in extreme conditions. This is clearly confirmed by single administration of vaccines to patients in epidemic focus of HAV. Constant regular monitoring of the duration of protection induced by one and two doses of the vaccine is required. The article considers WHO’s position on the use of vaccines for the prevention of HA. It describes the prospects of the further use of vaccines to control the spread of HA
