Cell 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».

In light of the increasing incidence of pertussis in many countries much attention is paid to vaccines for immunologic prophylaxis of pertussis. The article dwells upon the use of whole-cell and acellular pertussis vaccines (DTPs and DTaPs, respectively). The analyzed materials demonstrate that the choice of the vaccine (DTP or DTaP) plays a crucial role in the creation of the proportion of the population who are immune to the disease. The wide use of DTPs in 1950s-1960s resulted in more than a 90 % decrease in pertussis incidence and mortality rates. While DTPs are very efficacious they have also been associated with a high degree of reactogenicity (especially those vaccines produced abroad since they contain half or twice as many inactivated pertussis cells as Russian vaccines). An alternative variant is DTaPs which show signficantly lower reactogenicity as compared to DTPs. Available data demonstrate that licensed DTaPs and DTPs have equivalent primary efficacy in preventing the disease during the first year of life, but the effect of APVs is not as long-standing as that of DTPs and this results in a more rapid weakening of the immune system and decrease in the influence on pathogen transmission. Immune protection following the administration of DTaP booster doses decreases more rapidly in those people who received first immunization with a DTaP rather than a DTP. Experts believe that after administration of a repeat DTaP booster dose the weakening of the immunity will be still more rapid. Epidemiological surveillance data suggest that the use of DTaPs can lead to the resurgence of pertussis, and this resurgence may increase the risk of death for children who are too small to be vaccinated. This conclusion is supported by the increase in pertussis incidence in developed countries where the immunological prophylaxis is based on DTaPs only. It is important that specialists make their choice of the prophylactic vaccine based on its effect on the immunity duration and level.

The 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.

The article demonstrates that safe and efficacious use of allergen products for detection and treatment of allergic diseases relies on standardization and quality control methods. The article summarises various approaches to allergen products standardization that are used in the United States, the European Union and the Russian Federation. Development of requirements for allergen products of natural origin must take account of the heterogeneity of raw materials used in their production, since native allergen extracts are complex protein-polysaccharide mixtures consisting of allergenic (primary and secondary) and non-allergenic components. Standardization of methods used for evaluation of allergen products potency is performed using reference standards. To date, there exist several approaches to allergens standardization. The United States introduced a system of national reference standards whose biological activity is determined by one technique (IntraDermal Dilution for 50 mm sum of Erythema determines bioequivalent Allergy Units - ID₅₀EAL). In Europe each manufacturer establishes their own in-house reference standards (IHRS) and assigns them with units of activity. Products manufactured in the Russian Federation are standardized in protein nitrogen units (PNU).

The statistical analysis of trends in the quantitative data obtained during laboratory evaluation is one of the most important conditions of ensuring quality. Equally, the analysis of trends is necessary to confirm the compliance of biological medicinal products to the requirements of manufacturers’ quality standards and to ensure the reliability of laboratory tests. The article briefly surveys the positions of the World Health Organization (WHO) and the International Organization for Standardization (ISO) on the analysis of trends in the production of biological medicinal products, especially vaccines, as well as on methodological approaches to the planning and organization of random sampling checks.

The article describes the first attempt to use the juice and extract of Cyclamen europaeum (Cyclamen purpurascens) tubers as an adjuvant for intranasal immunization of mice with influenza antigens. The concentration of antigens used for immunization was 300 μg/ml for each subtype. The adjuvant was added at the concentration of 10 and 20 mg/ml. Blood serum was studied using the hemagglutination inhibition reaction (HI) and enzyme immunoassay (ELISA). After two immunizations with a dose of 7.5 μg, the maximum inverse titers to the H1/H3/B components in the HI were 320/80/80, respectively. The administration of an intranasal comparator without an adjuvant did not result in seroconversion which can be detected by the HI. The analysis of the blood sera of mice, immunized intranasally by the antigen only, showed no increase in the antibody levels between the first and second injections. For mice immunized intranasally by a preparation containing 10 mg/ml (0.5 mg per 50 μl dose) of adjuvant the ELISA detected a significant growth of antibody levels for all components, and GMT antibody levels were comparable to GMT antibody levels after a single intramuscular injection of 5 μg of each antigen. Despite a significant serum titer dispersion (which the authors explain by the impossibility of ensuring absolute uniformity in administration of 50 μl of substance via the nasal route) the use of the extract as an adjuvant for intranasal immunization of mice with highly concentrated influenza antigens showed a significant humoral response. The level of this response after two immunizations in some animals was comparable to that after intramuscular administration. The obtained data open the possibility of using Cyclamen europaeum tuber extract or its chemical analogues in further studies in guinea pigs, ferrets or other animal models in order to develop an efficacious adjuvant for intranasal immunization.

The article presents prospects for improving the evaluation of live tularemia vaccine (hereinafter - tularemia vaccine) quality in terms of the following parameters: «Identification», «Specific activity (the number of living microbial cells)» and the «Absence of extraneous microorganisms and fungi». The authors investigated the possibility of improving evaluation of tularemia vaccine quality as regards the «Identification» parameter by using a commercial diagnostic test kit - immunochromatographic test system for express detection and identification of tularemia agent («F. tularensis ICA test system»). In order to optimize and improve the evaluation of tularemia vaccine quality as regards «Specific activity (the number of living microbial cells)» parameter it is recommended to use a ready-to-use growth medium for cultivation and isolation of tularemia microbe - as an additional culture medium for determination of the number of living microbial cells. It is proposed to improve the methodology of tularemia vaccine quality evaluation as regards the «Absence of foreign microorganisms and fungi» parameter by eliminating the stage of subculturing material in thioglycollate medium for 5-7 days, which is reasonable from economic and practical points of view and also reduces the risk of false positive results.

The 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).

The article presents the results of a retrospective analysis of experimental data on the protective properties of the three seed lots of tuberculosis vaccines which have been used in the production of BCG and BCG-M vaccines since 1984. It was shown that these seed lots have comparable characteristics of viability, which accounts for their equivalent immunogenicity. An additional study of the protective properties of the preparations was carried out in guinea pigs vaccinated with production batches of tuberculosis vaccines containing a different amount of viable BCG cells in the vaccine dose. Exposure of animals to a virulent strain of M. tuberculosis 2.5 months after the vaccination demonstrated high immunogenicity of the tuberculosis vaccines. It was established that a fivefold reduction in the dose of a vaccine with a high content of viable BCG cells only slightly reduces the degree of protection of the animals from disseminated tuberculosis. Thus, the data obtained confirmed that the 30 % reduction of the upper limit of the viability (viable BCG) of the BCG and BCG-M tuberculosis vaccines aimed at reducing their reactogenicity does not affect the protective properties of the preparation. It is important to note that previous post-marketing surveillance of such improved vaccines has shown a significant reduction in the number of post-vaccination complications in children.