BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Оценка сопоставимости результатов определения фенола в иммунобиологических лекарственных препаратах
Get PDFThe article presents the practical assessment of the possibility of harmonization and standardization of methods for the determination of phenol in the immunebiological medicines. The evaluation of the statistical significance of differences in the results of determinations of phenol existing methods described in the standard documentation for foreign and domestic preparations: used ANOVA with Fisher’s exact test (F-test). The conclusion of the interchangeability of the studied methods for the determination of phenol in the immune-biological medicines and the opportunity of the development and certification of standard reference and sample validation measurements.В статье представлены материалы практической оценки сопоставимости результатов определения содержания фенола в иммунобиологических лекарственных препаратах полученных различными методами. Проведена оценка статистической значимости различий результатов определения фенола методами, описанными в НД на зарубежные и отечественные препараты: использован однофакторный дисперсионный анализ с применением критерия Фишера (F-критерия). Сделан вывод о взаимозаменяемости исследованных методов определения фенола в ИЛП и актуальности разработки и аттестации стандартного образца сравнения и образца подтверждения правильности измерений
Критерии отбора бактериальных штаммов и бактериофагов для формирования производственной коллекции, специфически лизирующих бактерии родов: Klebsiella, Echerichia, Proteus, Pseudomonas, Staphylococcus
No full textThe present article submits the results of work on the isolation and study of biological properties of bacteriophages, active against Klebsiella, Echerichia, Proteus, Pseudomonas, Staphylococcus. It also shows the results of the study such as: lytic activity, the definition of the spectrum of lytic action, sensitivity to damaging environmental factors: pH, temperature, freeze drying. The data of molecular genetic studies are provided.Представлены результаты работы по выделению и изучению биологических свойств бактериофагов, активных по отношению к бактериям родов Klebsiella, Echerichia, Proteus, Pseudomonas, Staphylococcus. Показаны результаты исследований по изучению: литической активности, определению спектра литического действия, анализу чувствительности к повреждающим факторам внешней среды: значению рН, температуре, лиофильному высушиванию. Приведены данные молекулярно-генетических исследований
Препараты крови человека и животных в аспекте показателей качества, эффективности и безопасности
No full textThe problems of quality and safety products derived from human blood plasma and hyperimmune animal sera as well as recombinant blood products resolved strict government regulation of their production processes. The risk of implications is minimized by plasma fractionation and purification of a specific drugs from various impurities (immunoglobulin aggregates, protease, plasmin, plasminogen, prekallikrein activator, IgA and IgM etc.). Viral safety is achieved by multi-step manufacturing process that includes at least two independent methods (treatment with solvent/detergent + incubation at low pH or pasteurization, combined with polyethylene glycol processing). It was justified that for today the technological process of the development of plasma preparations and hyperimmune animal sera has reached its limit. Their further development is the most likely to refer to specific improvements. The improvements will relate to increasing the efficiency of manufacturing technologies and methods of clinical use (preparations for subcutaneous administration, combinations of different immunoglobulin preparations, etc.), viral safety, ways to eliminate component, that were previously not considered to be able to influence the outcome of clinical use (soluble molecules CD4, CD8, HLA, thrombin, trace amounts of blood clotting factors VIII, IX, X, XI, XII etc.). At the same time new genetic engineered preparations with well-characterized molecular composition and a high selectivity for target impact are expected to appear on the market because of these unsolved issues. These are recombinant blood factors with altered properties; cocktails of recombinant antibodies and Fab-fragments of IgG, highly affine for toxin epitopes, etc. Therefore, in the upcoming years it is necessary to create in Russia a new system for assessing the quality, efficacy and safety of blood products, taking into account the future course of their development
Рекомендации по изложению методики оценки биологической (специфической) активности биотехнологических лекарственных препаратов в нормативной документации
Get PDFBiotechnological products, like all other medicinal products, have to comply with efficacy, safety and quality requirements. Quality evaluation of medicines includes assessment of test methods used to control medicinal product quality (described in product specification files provided by the manufacturer), laboratory testing of samples using these methods, as well as assessment of the registration dossier materials, including materials on test method validation included into the product specification files. One of the most important quality parameters of biotechnological products is biological activity, i.e. specific ability of a product to induce a desired biological effect. The article presents the results of a detailed analysis of methods used for determination of biological (specific) activity that are described in product specification files of various biotechnological products. The aim of the study was to demonstrate the importance of proper presentation of methods used for assessment of biological (specific) activity of biotechnological products and familiarise specialists engaged in elaboration of product specification files with the principles of presenting data in the «Biological (specific) safety» section. The analysis of documentation helped summarise the most common mistakes and omissions, formulate general recommendations concerning the description of methods, develop a general structure of the «Biological (specific) safety» section with detailed guidance on what to include in each of the subsections. Rationalisation of information presented in this part of the product specification files will help reduce the number of expert body’s requests for additional information/documents and will help ensure that laboratory testing is performed at a high professional level and within a prescribed period of time
Определение остаточной ДНК клеток-продуцентов E. coli и CHO в субстанциях рекомбинантых белков методом qPCR
No full textИзучение роли первичных иммунодефицитных состояний у детей с БЦЖ-оститами
Get PDFThe article presents an analysis of 522 cases of complications after BCG vaccination, i.e. post-vaccinal osteomyelitis, based on pharmacovigilance data obtained between 2001 and 2012. A detailed study of ill children revealed no clinical manifestations (severe bacterial, viral or fungal infections, repeat bacterial infections of respiratory tract, paraproctitis, chronic eczema etc) suggesting primary or secondary immunodeficiency. All of the 135 children who were vaccinated with measles, mumps and rubella vaccine and all of the 315 children who were vaccinated with live polio vaccine had no complications in the post-vaccinal period.В работе представлены результаты анализа 522 случаев генерализованной формы осложнений после прививок вакциной БЦЖ - поствакцинальных оститов, материалы о которых получены в процессе проведения фармаконадзора за период с 2001 по 2012 гг. Особое внимание было уделено клиническим показателям, характеризующим состояние иммунной системы ребенка. Детальное изучение состояния здоровья заболевших детей не выявило у них клинических проявлений (тяжело протекающие бактериальные, вирусные и грибковые инфекции, повторные бактериальные инфекции респираторного тракта, парапроктит, упорная экзема), свидетельствующих о наличии первичного или вторичного иммунодефицита, которые могли бы способствовать развитию данной формы поствакцинальной патологии. Заболевшие не имели противопоказаний к применению туберкулезных вакцин и хорошо переносили вакцинацию другими препаратами календаря прививок, в том числе живыми вакцинами
Микоплазмы - контаминанты клеточных культур
No full textThe safety of biological products derived from animal cells is associated with the properties of the cells themselves or their components, as well as with the possible presence of contaminants of microbial and viral origin. The suitability of cell substrate for production of prophylactic preparations is often determined by the features of the production process, which allows to benefit/risk ratio of the product. One of the common contaminants of cell substrates are mycoplasmas, type Mollicutes. As distinguished from other microorganisms they don’t have cell membranes, and parasitize a wide range of animals and plants, on the surface or inside the cells. Some mycoplasma species of are potentially pathogenic to humans, they compete for nutrients with cells in vitro , cause chromosomal aberrations, interfere with normal cell metabolism. The detection of mycoplasma contamination in cell substrates when manufacturing prophylactic preparations is required by regulatory documents.Безопасность биопродуктов, получаемых из клеток животных, связана со свойствами самих клеток или их компонентов, а также с возможным присутствием в них контаминантов микробного и вирусного происхождения. Пригодность клеточного субстрата для производства профилактических препаратов нередко определяется совершенством производственного процесса, который позволяет обеспечивать пользу/риск получаемого продукта. Одним из распространенных контаминантов клеточных субстратов являются микоплазмы, относящиеся к классу Mollicutes. Они отличаются от других микроорганизмов отсутствием клеточной мембраны, паразитированием на различных видах животных и растений, на поверхности или внутри клеток. Некоторые виды микоплазм потенциально патогенны для человека, in vitro конкурируют с клетками за питательные вещества, вызывают хромосомные аберрации, препятствуют нормальному метаболизму клеток. Выявление микоплазменной контаминации клеточных субстратов при производстве профилактических препаратов определяется требованиями нормативных документов
Исследование остаточной вирулентности и иммунизирующей способности посевных серий Mycobacterium bovis BCG-1
No full textThe article is devoted to a challenging issue of stability of seed lot systems that have been used in Russia since 1947 to produce BCG vaccines. This problem is underexplored and needs further investigation. In an earlier study the authors of the article used innovative (molecular genetic) methods to demonstrate the conformity of BCG-1 seed lots used in Russia to the international reference reagent ( BCG Vaccine of Russian BCG-I sub-strain-International Reference Reagent ) in terms of «Identification». This article lays out the results of new comparative studies of BCG-1 367 «shch» (1982) and 368 «shch» (2006). During the study special emphasis was put on such quality parameters as residual virulence (survival), specific safety (absence of virulent mycobacteria tuberculosis), sensitization effect (by induction of immune-mediated delayed hypersensitivity to tuberculin), and protective effects. The values obtained in the batches evaluation were very close and did not differ from the results obtained during certification performed just after the production of each seed lot. These results testify to the high degree of stability of the seed lots biological properties. The article also cites literary sources that address the issue in question
Аттестация отраслевого стандартного образца специфической активности вакцины полиомиелитной пероральной, двухвалентной, живой аттенуированной 1, 3 типов - БиВак полио
No full textThe standardization and control of «BiVac polio» (live attenuated bivalent oral polio vaccine type 1 and 3) developed by M. P. Chumakov Institute of Poliomyelitis and Viral Encephalitides of the Russian Academy of Medical Sciences, called for establishment of an industry reference standard (IRS) to be used in determination of infectious units for each type of the poliovirus in a vaccine dose, according to the requirements of the quality standard. The article gives an account of certification performed for the first batch of a live attenuated bivalent oral polio vaccine type 1 and 3 IRS. The following parameters were tested: Clarity, Colourity, рН, Sterility, Identification, Specific activity, Thermal stability. Identification, Specific activity and Thermal stability of the candidate reference standard were assessed in comparison with the vaccine poliovirus type 1 IRS (IRS 42-28-362-2016) and vaccine poliovirus type 3 IRS (IRS 42-28-372-2015). The IRS certified parameter was found to be: 107.38±0.38 TCID50/ml for type 1 and 106.7±0.48 TCID50/ml for type 3. The IRS was assigned with the number IRS 42-28-434-2016 and a shelf life of 1.5 years. The IRS can be used in specific activity testing of «BiVac polio» commercial batches