BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Вакцинопрофилактика полиомиелита на современном этапе
Get PDFPoliomyelitis is a typical anthroponosis, in natural conditions it infects only humans. The only effective strategy for combating the infection is preventive vaccination. The polio vaccine induces long-lasting humoral and local immunity. The article presents a brief history of polio vaccine development, and compares live and inactivated vaccines currently licensed and used in Russia. It also dwells upon the benefits and shortcomings of each of these vaccines. The results of analysis demonstrated that all foreign-made and domestically-produced polio vaccines currently used in Russia meet international requirements in terms of main quality characteristics and comply with the WHO recommendations. The article looks into some issues arising from the use of live polio vaccine, in particular the development of vaccine-associated paralytic polio, and the appearance of vaccine-derived polioviruses. It reviews the main approaches of the current WHO polio eradication initiative, and summarises the outcomes of the 30-year period since the adoption of the Global Polio Eradication Initiative. The article describes the transition from live attenuated oral polio vaccine (types 1, 2 and 3) to bivalent vaccine (live attenuated oral polio vaccine, types 1 and 3). It discusses the necessity of using polio vaccines (both live and inactivated) at the final stage of polio eradication. The article presents the new National Immunisation Schedule
Проблемы генотипирования микроорганизмов
No full textGenotyping efficiency depends on resolution of methods which provided by the target sequence of genome, efficiency of enzymes, primers and conditions of DNA restriction and PCR amplification. The most differential tools are methods involving the high evolutionary markers. They are methods MST, MLVA, DGE, HRM against to the method MLST based on the slow evolutionary marker. Methods PFGE, AFLP, DNA chips exploit the preliminary information of genome and have the better resolution than ribotyping and RFLP-PCR limited by certain loci. Monitoring of local outbreaks may be carried out using a rapidly evolving markers (methods RAPD-PCR, MST, or MLVA, DGE, HRM). The most suitable methods for prolongated epidemiological or population researches are MLST, PFGE, ribotyping and pyrosequencing analysis. Polymicrobial samples are investigated with DNA specific methods PCR-RFLP, MLVA, DGE, HRM, MLST, MST, DNA chips. The metagenomic analysis is the most informative to identify the species of bacterium from the polymicrobial sample. It is essential to use the conservative DNA sequences, for example 16S rRNA. The modern genotyping assays provide the informative and technological platform for phylogenetic studies of bacterial strains even through the several generations. The important results are figures of genetic distances between strains involving in complex of epidemiological characteristics: virulence, antibiotic resistance and the others. The computing tools for integration the phenotyping and sequencing data have developed. Whole-genome sequencing is the optimal method for bacterial genotyping. But there are several crucial restrictions of this method. It is still rather expensive and needs to operate with high quality DNA
Определение мертиолята в несорбированных ИЛП методом атомно-абсорбционной спектроскопии холодного пара (ААС-ХП) по ионам ртути. Часть 1: отработка методики и оценка статистической значимости различий результатов определения ионов ртути колориметрическим методом и методом ААС-ХПО
Get PDFThe article describes development of methods of quantitative determination of thimerosal in non-adsorbed immunobiological preparations by cold vapor atomic absorption spectroscopy as well as an estimation of the statistical significance of differences in the results determination of thimerosal conventional colorimetric method in combination with dithizone and CV AAS using one-way analysis of variance with Fisher’s exact test (F-test).В статье представлены материалы по отработке условий количественного определения содержания мертиолята в несорбированных иммунобиологических препаратах (ИЛП) методом атомно-абсорбционной спектроскопии холодного пара (ААС-ХП), а также проведена оценка статистической значимости различий результатов определения мертиолята традиционным колориметрическим методом в комплексе с дитизоном и методом ААС-ХП: использован однофакторный дисперсионный анализ с применением критерия Фишера (F-критерия)
Свиной трипсин в производстве биологических лекарственных препаратов. Риски и требования к безопасности
Get PDFTrypsin is a reagent widely used in the manufacture of biological medicinal products (BMPs). Until recently, pancreata of cattle, pigs and poultry were the main sources of trypsin preparations. The discovery of the disease called «transmissive spongiform encephalopathy» or «cow rabies» (TSE) in cattle in the late 1980s showed a clear need for limiting the use of this source. Given the potential risk of using trypsin obtained from cattle, porcine trypsin became more commonly used in the production of biological medicinal products. Enzymes obtained from raw materials of animal origin can be contaminated with circoviruses, parvo- and pestiviruses, and mycoplasmas that are common to pigs. Due to high resistance to physical and chemical treatment, these contaminants pose a potential risk to recipients of vaccines, as well as to other biological medicinal products. Prevention of contamination requires measures aimed at detection, reduction and inactivation of foreign agents, both in raw materials and during BMP production. The article considers the most common types of porcine trypsin contamination, methods of its detection, reduction and elimination. The article also contains information on the Russian and international requirements for the quality and safety of porcine trypsin used in the production of biological medicinal products
Орфанные препараты, принципы их регистрации и применения
Get PDFOne of the most complicated issues of modern medicine is diagnosis, treatment and prevention of rare diseases. In the structure of rare diseases the vast majority accounts for genetically determined disorders. The introduction of genetic testing methods helped to identify a lot of hereditary diseases, that currently reach the number of 8,000 cases and according to estimations the frequency of their detection is about to increase. Medicinal products for diagnosis or treatment of rare diseases form the group of orphan drugs. Biologicals are the most effective medicinal products in the whole group, due to their ability to bind specifically with the «target receptor», which allows to use them as targeted drugs. Another advantage of biologicals, compared with preparations of chemical origin, is their low toxicity. Orphan drug provision is the most severe issue because the treatment of severe forms of rare diseases may require the prescription of an expensive drug. Manufacturing of orphan drugs may be unprofitable for the reason of the low prevalence of rare diseases. Therefore, the availability of orphan drugs for patients depends on the amount of state participation in manufacture stimulation. In various countries regulatory requirements for the recognition of a disease as a rare disease, and marketing authorization procedures for orphan drugs are developed with due regard to the social and economic characteristics of the country. The article presents the analysis of the regulatory requirements for various countries for the detection of rare diseases, and a common approach to marketing authorization procedure for the drugs used in treatment of rare diseases, exemplified by biological orphan preparations
Аттестация отраслевого стандартного образца содержания антиальфастафилолизина и некоторые аспекты его практического применения
No full textThe article summarises materials on the certification of a candidate branch standard sample (BSS) of anti-alpha-staphylolysin content - OSO 42-28-342-2017 FSBI «SCEEMP» of the Ministry of Health of Russia, batch No. 34, production date April 1, 2017, expiry date April 1, 2018. According to the Certification programme the reaction of neutralization of staphylococcal toxin hemolytic properties was carried out to establish the range of the certified property of the candidate BSS against the WHO international standard (21±2 IU/ml). The BSS of anti-alpha-staphylolysin content can be used for quantitative determination of antibodies to staphylococcal exotoxin (alpha-staphylolysin) in the reaction of neutralization of staphylococcal toxin (alpha-toxin) hemolytic properties by specific antibodies present in human blood plasma and in a number of biologicals (normal and specific human immunoglobulins, purified and adsorbed staphylococcal toxins, and diagnostic staphylococcal toxin).Представлены материалы по аттестации кандидата в отраслевой стандартный образец содержания антиальфастафилолизина ОСО 42-28-342-2017, серия № 34, дата выпуска 01.04.2017 г., срок годности до 01.04.2018 г. В соответствии с Программой аттестации стандартного образца в реакции нейтрализации гемолитических свойств токсина стафилококкового экспериментально установлен диапазон значений аттестованной характеристики кандидата в ОСО по отношению к Международному стандартному образцу ВОЗ (21±2 МЕ/мл). ОСО содержания антиальфастафилолизина может быть использован для количественного определения содержания антител к стафилококковому экзотоксину (альфастафилолизину) в реакции нейтрализации гемолитических свойств токсина стафилококкового (альфатоксина) специфическими антителами в плазме крови человека и в ряде групп биологических лекарственных препаратов (иммуноглобулинах человека нормальных и специфических, анатоксинах стафилококковых очищенных и адсорбированных, токсине стафилококковом диагностическом)
Гетерологичные сывороточные препараты в практике современной медицины
No full textThe article contains data on the use of heterologous serum products in the treatment of some infectious diseases and snake bites. Despite achievements of preventive vaccination there are still cases of diphtheria and tetanus registered annually all over the world. Cases of botulism and gas gangrene are not uncommon either. There is also an important problem of snake bites treatment. Heterologous serum is mainly derived from the blood of horses immunized with bacterial anatoxins or toxins (snake venoms). They are included into the Russian List of Vital and Essential Medicines and in the WHO Essential Medicines List. Antivenoms are the only effective antidotes for the bites of venomous snakes, spiders, and scorpions. However, despite a self-evident demand in such products, there is a lack of antitoxic serum caused by the phasing out of its production in some countries, its low economic efficiency and stringent regulatory requirements for the safe production of blood products
Основные технологические процессы, используемые при производстве биомедицинских клеточных продуктов
Get PDFDeveloping specific, effective and safe biomedical cell culture products (BCCP) assumes the following standard operating procedures: a) developing cell line with specific cell composition; b) obtaining a sufficient amount of cells of a specific cell line for therapeutic use as a part of BCCP; c) quality control and standardization of the developed cell line. Experts believe mesenchymal stromal cells (MSC) to be the first choice for the purpose of stem cell therapy. The development of a cell line with a specific cellular composition includes five sequential steps: selection of donors, sampling of biological material, cell isolation from donor material, preparation of standardized homogeneous population of cells, characterization of cell line composition of the cell line and its certification. The process of obtaining a sufficient amount of cells of a specific cell line for therapeutic use as a part of BCCP includes the selection of culture medium for cultivation of MSC, in special bioreactors for cultivation and culture control parameters. Quality control and standardization of the developed cell line assumes the elaboration of general requirements for quality parameters, characterizing all cell lines; as well as specific requirements for the assessment of therapeutic preparations in accordance with their proposed indications (for example, for the treatment of diabetes, bone grafting, restoration of blood supply to ischemic myocardium). The article describes typical procedures and identifies possible checkpoints for common technological methods used in BCCP manufacture and their quality assessment. It also outlines the requirements for the content of documents submitted by BCCP developer to an official authority in marketing authorization dossier as well as the expert evaluation procedure
Особенности аттестации и перспективы применения стандартного образца тест-системы для определения фракционного (антигенного) состава препаратов из сыворотки крови человека методом иммуноэлектрофореза
No full textThe article gives an account of certification performed for a new batch of a Reference standard to be used with the test system for determination of the fractional (antigenic) composition of human serum products by immunoelectrophoresis -industry reference standard (IRS) 42-28-77 - in accordance with existing requirements. A candidate reference standard was represented by a batch of normal human serum intended for diagnostic purposes (more than 500 donors) and a batch of immunoelectrophoresis serum against human serum proteins (antiserum against human serum proteins). In accordance with the certification programme, the fractional (antigenic) composition of the reference standard was determined by immunoelectrophoresis using «KliniTest-EF» buffer and 0.05 M borate buffer solution and the modes stipulated in the general monograph 1.8.2.0002.15 Agar gel immunoelectrophoresis. The reaction between the antiserum against human serum proteins and the normal human serum components of the reference standard produced at least 15 precipitation lines. The study demonstrated that the bromphenol blue dye could be used together with «KliniTest-EF» buffer to assess albumin migration, and the pyronin B dye could be used together with «KliniTest-EF» buffer and 0.05 M borate buffer solution to assess immunoglobulin migration. The study confirmed the applicability of the certified reference standard designed for the test system for determination of the fractional (antigenic) composition of human serum products by immunoelectrophoresis, and set the criteria for its use in the context of human serum products identification (species specificity) testing not only by immunoelectrophoresis, but also by agar-gel immunodiffusion
Тест-система для определения наличия связывающих антител к интерферону бета-1а для клинического применения
No full textTest system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms).Разработана тест-система для определения наличия связывающих антител к интерферону бета 1а (САт к ИФН бета-1а) в сыворотке крови человека с использованием метода твердофазного иммуноферментного анализа. С целью описания характеристик тест-системы проведены валидационные мероприятия, включающие исследование чувствительности, селективности, специфичности, прецизионности и точности, робастности, стабильности, пригодности тест-системы. Показана применимость данной тест-системы для использования в рамках клинических исследований - оценка иммуногенности препаратов интерферона бета-1а (пегилированных и непегилированных форм)