BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение
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Валидация XTT-теста для оценки антипролиферативной активности препаратов на основе моноклональных антител
Get PDFUsing the example of Herceptin (Roche) a method of assessing the antiproliferative activity of monoclonal antibodies using tetrazolium salt was developed. The method is based on spectrometric measurement of the level of formazan transformed by living cells from a water soluble salt XTT. The level of formazan is proportional to the number of viable cells. The technique was in terms of specificity, calibration curve, accuracy and precision.Методика оценки антипролиферативной активности препаратов моноклональных антител с применением соли те-тразолия XTT отработана на примере препарата Герцептин™ («Roche»). Метод основан на спектрометрическом анализе уровня формазана, трансформированного живыми клетками из водорастворимой тетразоливой соли ХТТ. Уровень формазана пропорционален количеству жизнеспособных клеток. Методика была валидирована по показателям: специфичность, линейность, правильность и прецизионность
Оценка стабильности показателей качества отечественной вакцины против гриппа, предназначенной для иммунизации населения в течение эпидемического сезона 2017–2018 гг.
Get PDFThe efficacy of influenza vaccines has been a matter of considerable debate ever since the development of the first influenza vaccine. The efficacy of currently used influenza vaccines depends on many factors, including the strain composition, the degree of homology between the produced and epidemic influenza viruses, the vaccination coverage, and many other factors. Assessment of quality, i.e. determination of compliance of the product’s quality characteristics with the specification requirements, and assessment of risks associated with the use of the product were considered only in the context of general requirements for the quality of biologicals. The article summarises the results of analysis of batch to batch consistency of the influenza inactivated polymer-subunit vaccine. The study included a retrospective assessment of the data obtained during the product release control and testing performed by an accredited testing centre as part of mandatory certification. The data obtained may be used to improve the production method and the system of statistical management of the production process, as well as to assess the risks accompanying the production of influenza vaccine at each of the stages
Использования биотехнологических препаратов как способ повышения безопасности фармакотерапии: современное состояние проблемы и перспективы развития
No full textDevelopment and improvement of biotechnological drugs currently more relevant than ever. Drugs obtained by means of biotechnology, have a number of positive qualities. Biotechnology allows you to create such products, which are currently impossible to synthesize by chemical means, in addition, the production of drugs using biotechnology meets the standards of quality, efficacy and safety and, more importantly, economically. Biotech drugs are used for treatment of infectious, autoimmune, cancer, are used to prevent, thereby finding wide application in medicine.В настоящее время разработка и усовершенствование биотехнологических препаратов представляет собой актуальную проблему для фармацевтической промышленности. Данные препараты имеют целый ряд положительных качеств по сравнению с их аналогами. Биотехнологические методы позволяют получить более дешевые, безопасные и эффективные препараты белковой и нуклеотидной природы, которые могут использоваться в лечении различных заболеваний: инфекционных, онкологических, аутоиммунных. Кроме этого, биотехнологические препараты также находят широкое применение в профилактике и диагностике болезней различной природы
Оценка иммунобиологических свойств вакцинных штаммов Bordetella pertussis
Get PDFThe study performed as part of evaluation of immunobiological properties of Bordetella pertussis vaccine strains offered an opportunity to standardize pertussis bacterial mass based on the content of surface antigens — agglutinogens 1, 2 and 3. Certain levels of agglutinogens in seed lots were found to be capable of modifying the protective activity of pertussis vaccine. The heterogeneity of the bacterial strain population was reduced by applying selection criteria for colonies based on expression of agglutinogens. B. pertussis seed lots derived from vaccine strains that had undergone selection were sent to manufacturers of the pertussis component of DTP vaccine. Production of pertussis vaccine using a more homogenous bacterial mass that actively expresses agglutinogens 1, 2 and 3 made it possible to enhance immunogenic activity of the pertussis component of DTP vaccine. The safety of the whole-cell pertussis vaccine produced from the standardized seed lot was not compromised
Оптимизация способов математической обработки калибровочных кривых при оценке молекулярной массы биологических лекарственных средств методом электрофореза в полиакриламидном геле с SDS
No full textМировая практика хранения клеточных линий человека, предназначенных для применения в клинических целях
Get PDFCurrently, the Russian Federation does not have a well-established state-controlled market for cell banks (CB) containing cell material that is potentially applicable for clinical purposes. Cryopreservation of cells in cell bank (CB) is an important step in the production of a number of biomedical cell products and makes it possible to overcome difficulties faced by manufacturers during production and storage of large amounts of cell material. At present there are a large number of human cell lines in the world, which are stored in CB owned by commercial and public organisations in different countries. In addition, new cell lines are being banked every year. All this makes it difficult to find cell material suitable for production purposes or that could potentially be used as donor material in clinics. This study analysed the international practice of storing human cell lines for clinical use. The authors of the study systematised the existing CB worldwide and analysed regulatory documents governing the activities of these banks in different countries. The analysis revealed a trend towards formation of CB, often specialising in certain types of cells, as well as a trend towards creation of registries giving full information about cell lines including data on their scientific application. The increasing development and clinical use of cell therapy products in the Russian Federation and abroad will most likely lead to the increase in the number of CB and registry systems, as well as amounts of materials stored in them, including cell lines intended for clinical use
Оценка качества вакцины туляремийной живой по результатам испытаний в рамках обязательной сертификации
No full textThe results of the tests for the quality assessment of live tularemia vaccine under the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation in 2011-2015 were analyzed in the present article. There were 14 batches (of 34) which did not comply with the requirements of regulatory documents (RD) in terms of «Specific activity (percentage of live microbial cells)», «Number of cutaneous doses» and «Thermal stability». The experimental results had confirmed the irregularity of tularemia vaccine batch samples in terms of «Specific activity (percentage of live microbial cells)» which, respectively, led to differences in vaccine samples in terms of the number of cutaneous and intradermal doses. It was confirmed that FT-agar is a nutrient providing all the necessary conditions for cultivating Francisella tularensis strain. Possible causes of irregular quality of the batches released in 2011 was considered in the present article. Test results for 93 batches of tularemia vaccine manufactured in 2012-2015 shown their full compliance with the requirements of RD. Consistent quality assurance of tularemia vaccine became the basis for the possibility of choice, certification and approval of new drug batches as industrial reference standards
Экспериментальное изучение эффективности удаления вирусов гепатитов B, C и парвовируса B19 при фракционировании плазмы крови этиловым спиртом
No full textThe purpose of the study was to assess the effectiveness of the removal of nucleic acids (NA), Hepatitis B (HBV) and C (HCV) viruses and parvovirus B19 (B19V) from blood plasma fractions obtained by alcohol separation. The studies were performed in a model experiment by fractionation normal pool plasma donation contaminated with virus-containing samples in the laboratory. It was found that the multi-step process to extract a fraction II, designed to provide the immunoglobulin G, provided the elimination of NA HBV and HCV to undetectable levels by PCR, and the total reduction factor compared to the original composition of the plasma HBV DNA >5.35 log, HCV RNA >4.84 log. Factor DNA V19V reduction was at the level of 4.56 log(CI 4.49-4.63). Upon receipt of the fraction V (for albumin) reduction factor of the test virus was >3.0 log wich in combination with additional purification step provides a reliable level of safety. The selection fraction I resulted in effectiveness of the elimination of HBV DNA and V19V DNA less than 2 orders, HCV RNA - less than 3 orders of magnitude, it is not enough to recognize the stage reliable. Experiments confirmed that the high risk of contamination of production pools parvovirus B19 additional safety measures are necessary, including mandatory investigation of plasma DNA V19V. In general the development of a full cycle of drug from blood plasma from donors, basic process alcohol fractionation steps necessary to supplement validation virus elimination and inactivation considering residual risk of contamination with pathogenic agents feedstock
Вакцинопрофилактика туберкулеза
Get PDFBCG vaccine for tuberculosis was developed nearly 100 years ago and still remains the only medicine for specific immunological prevention of tuberculosis. Despite the fact it has been actively used for a long time in more than 100 countries, the results of vaccination are very contradictory. The protective effect of BCG vaccination is assessed from 0 to 80%, while the efficacy of BCG vaccination in children, especially in infants, is generally recognized. BCG helps to reduce tenfold the number of tuberculous meningitis and disseminated tuberculosis in children. However BCG neither protects the population from mycobacteria infections nor the adults from pulmonary tuberculosis, although it prevents extrapulmonary tuberculosis. For the last 20 years new tuberculosis vaccines have been intensive developed, their efficacy is believed to exceed the efficacy of BCG vaccine, with the minimized adverse reactions. Nevertheless out of more than 200 tuberculosis vaccine candidates only few were allowed for clinical trials. In the upcoming years the humanity can not count upon a medicine that could replace BCG. Therefore the research efforts should be focused on improving BCG vaccine in order to enhance its protective effect and to reduce adverse effects
Дизайн доклинических исследований биомедицинских клеточных продуктов: особенности, ключевые принципы и требования
No full textAccording to the Federal Law «On Biomedical Cell Products», preclinical trials are an integral part of biomedical cell product (BCP) development. This article describes the basic principles of fulfilling requirements laid down in the Rules for conducting preclinical trials of BCPs. The main objective of preclinical trials is evaluation of efficacy, safety and biodistribution of cell products. Properly justified markers of biological activity must be used for reliable identification of BCP pharmacodynamic action in the host organism. BCP safety assessment must be comprehensive and include identification, characterization and quantitative evaluation of potential local and systemic toxicity, estimation of the onset of toxicity and possibility of its reduction, and the effect of a particular drug dose on the results of toxicity studies. The ultimate goal of preclinical toxicity studies is to obtain data sufficient for making a conclusion on the possibility of conducting clinical trials of BCP and determining associated risks. The key principles of preclinical trials design are a rational approach and justification of all decisions made during the study. The results of preclinical trials that were conducted in compliance with the law, can be included in the BCP dossier and considered during the product authorization by the expert institution of the Ministry of Health