BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Культуры клеток в заместительной терапии
No full textCell replacement therapy is one of the top priority areas of modern medicine, which is aimed at restoring the structure and functions of damaged tissues by transplanting cells grown in vitro . The article summarizes data obtained in several studies of diploid cell lines (allogeneic fibroblasts) used as replacement therapy in various therapeutic areas as part of application of medical technology innovations. The article describes benefits of using fibroblasts and the routes of cell culture administration. At present the use of medicinal products containing viable human cells (biomedical cell products) is regulated by Federal Law 180-FZ «On biomedical cell products» of 23 June 2016. Cell cultures used in the production of biomedical cell products should be morphologically homogeneous populations of cells derived from a specific tissue and should have a limited life span, a stable karyotype (at least 75 % of cells should have a double set of chromosomes), should not be associated with cancer risks, be free from extraneous agents, have low levels of histocompatibility antigens expression. According to 180-FZ, all characteristics of a cell line supporting the quality of a biomedical cell product should be reflected in the biomedical cell product specification. Before the adoption of 180-FZ only certified cell cultures could be clinically used. The therapeutic potential of fibroblasts related to optimization of reparative processes, improvement of regenerative and adaptive capabilities, as well as the accumulated experience of their clinical use are stirring interest to the development of fibroblast-based biomedical cell products and their use as replacement therapy. However, it should be pointed out that according to 180-FZ biomedical cell products may not be produced using «biological material obtained by interrupting or jeopardising an embryo/fetus development process»
Разработка и аттестация отраслевого стандартного образца для оценки подлинности вакцины менингококковой группы А полисахаридной
No full textThe article highlights the materials on the development and certification of the industrial reference standard (IRS) for identification of meningococcal polysaccharide vaccine group A. The scheme and methodology for IRS certification have been developed. Samples of the vaccine IRS candidate have been tested in terms of: «Description», «Dissolution time», «Transparency of reconstituted solution «, «Colourity of reconstituted solution», «Particulate matter «, «Loss on drying», «Accuracy of filling» «Phosphorus», «Sterility», «Pyrogenicity», «Abnormal toxicity», confirming their compliance with the current Pharmacopoeia monograph MP-00392-180512. The certified characteristic has been determined: IRS should slow down passive hemagglutination (PHIA) in «A» homologous system with polysaccharide concentration in the range from 0.19 to 0.39 μg per 1 ml in the absence of the inhibitory effect in «C» heterologous system with polysaccharide concentration of 50 μg per 1 ml. The shelf life of the IRS meningococcal group A polysaccharide vaccine for identification has been set against the vaccine shelf life and has been equal to 2 years. The set of regulatory documents on the scientific and technical product IRS 42-28-428-2014 IRS meningococcal group A polysaccharide vaccine for identification (certificate, draft label of primary package and patient information leaflet) has been approved
Динамическое светорассеяние - простой и чувствительный метод, позволяющий определять появление иммунных комплексов в биологических жидкостях
Get PDFIn this paper we introduce new approach in formed in heterogeneous biological fluids immune complexes analysis. The approach is based on an analysis of the contribution of immune complexes in dynamic light scattering, recorded by laser correlometer with heterodyne measurement circuit. We demonstrated our approach sensitivity using embryonic calf serum model in addition of monoclonal antibody against hepatocuprein. Proposed approach is capable to detect forming immune complexes by adding antigen at a concentration greater than 150 pg/ml. Using immunoaffinity techniques we confirmed the lawfulness of identified peaks in the histograms of dynamic light scattering as appropriate immune complexes. For these purposes, we selectively removed immune complexes using staphylococcal protein A sepharose immobilized on the particles or increased in size immune complexes due to their further aggregation using antibodies specific for human immunoglobulin. The proposed approach can detect immune complexes in various biological fluids
Исследование кросс-реактивности терапевтических препаратов на основе моноклональных антител на тканях человека: основные подходы и методические приемы
Get PDFTissue cross-reactivity (TCR) studies are screening immunohistochemical (IHC) assays, usually conducted on frozen human and animal tissues. This study is obligatory for getting the permission for clinical trials in Russia for all innovative therapeutic products based on monoclonal antibodies or antibody-like molecules that contain complementarity-determining region (CDR). In this article are represented approaches and methodical features for successful conduction of tissue cross-reactivity studies with examples from own authors’ experience.Исследование тканевой перекрестной реактивности (кросс-реактивности, TCR, Tissue cross-reactivity) представляет собой скрининговое иммуногистохимическое исследование, которое обычно проводят на замороженных тканях человека и животных. Данное исследование обязательно для получения разрешения на клинические исследования в Российской Федерации любого инновационного терапевтического препарата на основе моноклональных антител или антителоподобных молекул, содержащих участок, определяющий комплементарность (complementarity-determining region, CDR). В данной статье представлены подходы для изучения и методические приемы для успешного проведения исследования тканевой перекрестной реактивности с примерами из собственного опыта авторов
Основные подходы к управлению данными для администрирования биологических коллекций
No full textThe article analyses the main principles of and approaches to software and hardware solutions and platforms that could be used in the development of data management systems for biological collections. The authors summarise the key requirements for functional capabilities of the software which could be used to support biological resources databases and which is a prerequisite for maintaining a highly organized biological collection. The article sums up the main approaches to restricting access to information on biological collections as required by the patent procedure and biological safety principles. The authors identified specific aspects of developing information support systems for public biological collections.Проведен анализ основных принципов и подходов к использованию программно-технических решений и платформ, применение которых возможно при разработке систем управления данными в биологических коллекциях. Сформулированы основные требования к функциональным возможностям программного обеспечения, предназначенного для поддержки баз данных по биологическим ресурсам и являющегося необходимым атрибутом функционирования биологической коллекции высокого организационного уровня. Рассмотрены основные подходы к ограничению доступа к информации о биологических коллекциях в случаях, предусмотренных патентной процедурой и правилами биологической безопасности. Определены особенности разработки систем информационного обеспечения открытых сервисных биологических коллекций
Вакцины с адъювантами. Доклинические исследования
Get PDFThe paper presents the data on safety and efficacy assessment of adjuvants and vaccines with adjuvants at the stages of development and preclinical studies based on international recommendations. The presence of an adjuvant in vaccine content ensures higher expressing and prolonged specific immunity. The origin and nature of adjuvants currently used for various vaccines are different. Adjuvants can be classified by origin, mechanism of action, physical and chemical properties. The finished vaccine may contain one or more adjuvants which can be intended for one antigen or a number of antigens in vaccine content. Antigen-adjuvant combination is a key part in the production of a vaccine with an adjuvant. Due to the diversity of adjuvant nature and their physical and chemical properties and mechanisms of action, as well as to antigens in adjuvant vaccines content, it is rather complicated to plan and to conduct preclinical studies. The present article describes various aspects of preclinical studies of adjuvants and vaccines with adjuvants based on the analysis of current guidelines and requirements
Методические подходы к валидации технологических процессов получения терапевтических рекомбинатных белков на основе концепции «Quality by Design»
Get PDFValidation of production processes based on the Quality by Design (QbD) principles calls for thorough scientific understanding of the processes and enhancement of their stability by implementation of new technologies. The aim of the study consisted in substantiating a QbD-based technological approach to validation of commercial production of dornase alfa. For this purpose a design space was established in a scale-down model, i.e. 2 L reactors; the model was shown to be representative in terms of all parameters except for the reactor size; the similarity of hydrodynamic conditions, design characteristics and operation modes of laboratory, pilot and commercial scale reactors was established; the process scalability was demonstrated by using the PCA (Principal Component Analysis) multivariate mathematical model including the volume range of 2–1000 L, input and output process parameters and product quality attributes for a number of recombinant therapeutic products derived from the same CHO cell line and expression construction as dornase alfa producer. The article demonstrates the applicability of engineering space, which includes bioreactor design features and production process parameters, to different production scales by implementing 3 processes at the pilot scale (100 L) and 2 processes at the commercial scale (1000 L) and building a PCA model based on the obtained data
Роль российских и советских ученых в разработке сибиреязвенных вакцин
Get PDFIn Russia in the second half of the XIX century research schools, developing anthrax vaccines for agriculture were formed. Their level was highly competitive with the Western analogues. At the end of the 1930 Soviet military scientists were the first in the world to create the anthrax vaccine for medical use on the basis of the spores of unencapsulated live strains of B. anthracis. In the 1940-1960-ies Russian scientists determined the principles of the development of anthrax vaccines, which allowed to avoid failures of their Western colleagues, when developing the vaccines capable of protecting the population from biological weapons with anthrax spores as the harmful agent. Russian military scientists in the 1990s managed to keep the vaccine strains of anthrax bacteria and restore the technological capability for their manufacture, which helps to protect the population of the Russian Federation from natural anthrax outbreaks and from biological terror. At a time when there is a need in creating immunity in humans against infection caused by inhalation of anthrax spores, the most reasonable decision for the upcoming decades is to use the domestic combined vaccine that combines unencapsulated live strains of Bacillus anthracis and anthrax toxin protective antigen