BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Молекулярно-биологические методы контроля качества субстанций биологических лекарственных препаратов, полученных с использованием технологии рекомбинантной ДНК
Get PDFBiotechnological products manufactured by recombinant DNA technology are widely used nowadays. According to the national and international requirements the amount of residual host cell DNA in such products should not exceed 10 ng per dose. However, for products intended for frequent or long-term use, this amount must not exceed 100 pg per dose. This article describes methods most frequently used for quantification of residual host cell DNA in biological active substances contained in biotechnological products: molecular hybridization with biotin- or digoxigenin-labelled DNA- probes (semiquantitative method), Threshold system, real-time PCR, method based on the use of a fluorescent reagent (assays). If a method based on the use of a fluorescent reagent or real-time PCR are used to replace the current procedure, it is necessary to demonstrate their validity, e.g. by comparing the results of residual DNA quantification obtained by the two methods — the new one and the current one. The article dwells upon the advantages and disadvantages of the methods and potential sources of uncertainty. It highlights the importance of using appropriately certified reference standards and retention samples. The biological active substances included into the State Register of Medicinal Products conform to the international requirements in terms of the amount of residual host cell DNA
Обзор методических подходов к оценке качества лекарственных средств на основе рекомбинантных интерферонов
No full textThe article summarises methods used to control the quality of recombinant interferon alpha and beta (IFNs) products. It demonstrates that currently used methodological approaches generally ensure proper quality control of this group of medicines. However, it is necessary to formulate basic requirements for the pharmacopoeial general chapters on interferon alpha-2 and beta-1 products in order to standardize the control procedures and increase the efficacy and safety of recombinant IFNs products. These requirements should be harmonized with requirements of both the European Pharmacopeia and pharmacopoeias of the Eurasian Economic Union member-states, and should take account of the current trends in the Russian pharmaceutical industry.Представлен обзор методов, используемых для определения показателей качества лекарственных средств на основе рекомбинантных интерферонов (ИФН) альфа и бета. Показано, что применяемые на сегодняшний день методические подходы в целом обеспечивают надлежащий контроль качества этой группы препаратов. Однако, для унификации контроля и повышения эффективности и безопасности лекарственных препаратов рекомбинантных ИФН необходимо формирование основных требований к общим фармакопейным статьям (ОФС) на субстанции интерферонов альфа-2, бета-1, основанных на принципах гармонизации с требованиями Европейской фармакопеи и фармакопей государств-членов ЕАЭС и учитывающих современные тенденции развития российского рынка лекарственных средств
Оценка подлинности и стабильности производственных и контрольных штаммов - возбудителей актуальных инфекций бактериальной этиологии
Get PDFThe paper presents the results of identification of a spectrum of biochemical activity and certification of 140 bacterial strains of I-II risk level deposited in the State collection of pathogenic microorganisms of Scientific centre for expert evaluation of medicinal products of the Ministry of health of the Russian Federation. Causative agents of meningitis, dysentery, salmonellosis and other acute gastrointestinal, pyoinflammatory infections, including nosocomial, and other epidemiologically significant infections which can be applied for manufacturing and an quality assessment medicinal and diagnostic preparations, including vaccines, toxoids, therapeutic and prophylactic bacteriophages, antimicrobic drugs, diagnostic serum, test system, nutrient media were evaluated. Correction of a taxonomic nomenclature of collection strains according to requirements of Bergey’s manual of systematic bacteriology (2nd ed) was provided. A possibility of selection of the analogs of cultures of the microorganisms deposited in national collections of other countries and applied by production and quality control of immunobiological medicines and also for quality assessment of laboratory researches is proved. Stability of pivotal phenotypic properties and lack of dissociation master-seed and test strains is confirmed at freeze-drying for over 40 years
Биоаналоговые (биоподобные) лекарственные препараты рекомбинантного гранулоцитарного-колониестимулирующего фактора. Оценка качества
Get PDFThe article describes general principles of evidence-based quality assessment research of a recombinant granulocyte colony stimulating factor preparation (G-CSF) under development as well as a confirmation of its similarity to reference preparation (authorized original preparation). Since the quality of biotech preparations is determined by the manufacturing process, when developing a biosimilar one should focus on the manufacturing process details, starting from the selection of the expression system, the composition of excipients, on to the methods of isolation and purification of recombinant protein. Recombinant protein should be characterized in more details, than the quality parameters of the original preparation, included in the specification of the substance or the preparation. Comparative studies include characterization of the active substance and the assessment of the quality of the finished product. The reference preparation in the development of a biosimilar G-CSFВ статье приведены общие принципы проведения научно обоснованных исследований по оценке качества разработанного препарата рекомбинантного гранулоцитарного-колониестимулирующего фактора (рчГ-КСФ) и доказательства его подобия референтному (ранее зарегистрированному оригинальному препарату). Поскольку качество биотехнологических препаратов определяется процессом производства, при разработке биоаналогового (биоподобного) препарата основное внимание должно быть уделено вопросам процесса производства, начиная от подбора системы экспрессии, состава вспомогательных веществ препарата, методов выделения и очистки рекомбинантного белка. Рекомбинантный белок должен быть охарактеризован по показателям, спектр которых должен быть шире, чем оцениваемые показатели качества оригинального препарата, включенные в спецификацию субстанции или лекарственного препарата. Сравнительные исследования включают характеристику действующего вещества и оценку качества готового лекарственного препарата. Препаратом сравнения при разработке биоаналогового (биоподобного) препарата рчГ-КСФ (филграстим), как правило, является Нейпоген®. В ряде аналитических методик используют стандартный образец ВОЗ - Международный стандарт рчГ-КСФ NIBSC (код 09/136). Сравнительные исследования включают оценку состава; физико-химических свойств; первичной структуры и конформации белка; чистоты; качественного и количественного содержания родственных соединений и посторонних примесей, связанных с процессом; биологической активности. Действующее вещество (рекомбинантный белок), присутствующее в биоаналоговом (биоподобном) препарате, должно иметь высокую степень подобия действующему веществу референтного (оригинального) препарата. При выявлении значительных различий в показателях качества разработанного препарата, которые могут оказать воздействие на показатели его безопасности и (или) эффективности, препарат не может рассматриваться как биоаналоговый (биоподобный). Проведение исследований по оценке качества является первым этапом изучения препарата, результаты которого определяют необходимость проведения, объем и вид дальнейших доклинических и (или) клинических исследований. Положения, изложенные в статье, базируются на опыте оценки качества препаратов филграстима, одобренных СНМР в странах Евросоюза как биоаналоговые (биоподобные) - «biosimilars», «biosimilar medical products»
Характеристика кандидата в стандартные образцы аллергена из пыльцы тимофеевки луговой по белковому профилю и специфическим аллергенным компонентам
Get PDFMedicinal products based on pollen allergen extracts are widely used for diagnosis and therapy of pollinosis. According to the requirements of the State Pharmacopoeia of the Russian Federation, 13th ed., the allergenic potency of such products is assessed against certified reference materials whose biological activity was confirmed in vivo in subjects sensitized to particular tested allergens. The finished dosage form of a candidate In-House Reference Material (IHRM) of timothy pollen allergen extract and the corresponding allergen pollen extract (intermediate) were characterized in terms of protein profile and allergenic composition using SDS-PAGE, gel- filtration HPLC, and western blotting. The test samples were compared to finished pharmaceutical products (FPP) and pollen allergen extracts produced at different dates and made from pollen harvested at different dates, as well as to the WHO International Standard (IS) of Timothy Pollen Extract (NIBSC code: 82/520). SDS- PAGE and gelfiltration HPLC showed that the candidate IHRM protein profile was comparable in terms of major protein fractions to those of all the FPP batches and pollen allergen extracts produced at different dates. HPLC confirmed the comparability of the protein profiles of the candidate IHRM and the IS (NIBSC code: 82/520), but showed minor variations in the ratio of the main protein fractions. Western blotting confirmed the presence of the main allergenic components with relative molecular masses ranging from 50 to 60 kDa and from 27 to 35 kDa. The composition of specific allergenic components of timothy pollen allergen products manufactured by JSC «SIC «Microgen» was identical with that of the WHO IS of Timothy Pollen Extract in terms of the main protein and allergenic components.
Применение методов цитогенетического анализа при оценке качества клеточных линий в составе биомедицинских клеточных продуктов
Get PDFBiomedical cell products (BMCPs) are a new group of biologicals that are based on various cell lines and are used in the treatment of a wide range of diseases as well as in the field of regenerative medicine. The quality control of the cellular component in such preparations is very important at all stages of BMCPs development and production. Much attention should be given to confirmation of BMCPs safety because of their specific properties and potential side effects, including the risk of cancer development. Carcinogenesis may be attributed to genetic instability of the BMCP cellular component. A number of cytogenetic methods can be used at the chromosomal level in order to identify the genetic instability of cells in a BMCP. Confirmation of the normal karyotype of cells and identification of various chromosomal abnormalities can be achieved using both classic cytogenetic analysis methods, such as chromosome banding, and molecular cytogenetic methods based on the use of fluorescent in situ hybridization. Combination of these methods may provide a reliable estimation of genetic stability of the cell line in a BMCP, and indirect evidence of absence of malignancy
Сравнительный анализ использования цельноклеточных и бесклеточных коклюшных вакцин для профилактики коклюшной инфекции
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Трансплантация фекальной микробиоты: возможные терапевтические подходы и вопросы правового регулирования
Get PDFSince Ilya Metchnikoff’s studies, both medical science and clinical practice have accumulated a large amount of evidence that human intestinal microbiota possesses a unique characteristics for our existence. However, only recently, scientists have achieved the actual breakthrough in this field of human physiology, and we start to understand the precise mechanisms of the complex interplay of microbial activity with human homeostasis and discover numerous new functions of intestinal microbes. In this regard, a novel medical technology evolves since 1958, so called fecal microbiota transplantation (FMT), which is the administration of donor feces to the patients suffering from different kinds of diseases. Such infusion of donor feces restores the natural balance of gut commensal germs. FMT is most efficacious in severe or recurrent Clostridium difficile infection. FMT has been also reported to cure diarrhea and constipation caused by different conditions, such as multiple sclerosis, Crohn ’s disease etc. In the U.S. and Canada as well as in other countries FMT is of uttermost interest of not merely clinical practitioners but lately also of regulatory authorities. The paper also addresses the possibility of application the Russian pharmaceutical legislation to FMT