Many acute viral infections cause similar clinical symptoms, therefore, establishing the etiology of a viral disease requires the use of whole complexes of serological or PCR tests designed to detect a particular type of pathogen. Modern methods of molecular biology allow early diagnosis of viral diseases at a time when serological diagnostic methods are not yet effective. The aim of the work was to analyze molecular diagnostic methods that allow the determination of viral nucleic acids in human blood. The article presents the classification of molecular methods for the diagnosis of viral particles in clinical specimens. Methods such as in situ hybridization, reverse transcription reaction (RT-PCR), nested PCR, multiplex PCR, as well as DNA microarray technology, and the method of massive parallel sequencing are considered in detail. Particular attention is paid to NGS-technologies that were used in virology almost immediately after their appearance and allowed for detection of a number of new types of human viruses (including representatives of anelloviruses, picornaviruses, polyomaviruses, etc.). The advantages and problems associated with the application of these methods in clinical practice, as well as the prospects for their improvement are discussed.

Currently, 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.

The article presents the results of a retrospective analysis of viral hepatitis B incidence in the Russian Federation from 2013 to 2017, taking into account the use of vaccines included into the National Immunisation Schedule and the Immunisation Programme in Case of Epidemic Outbreaks. The analysis of the data revealed a trend towards a reduction in the incidence of acute and chronic forms of hepatitis B in the territory of the Russian Federation during the past five years. The reduction of viral hepatitis B incidence was achieved thanks to a higher vaccination coverage of both children and adults. The article presents an overview of monovalent and combination recombinant hepatitis B vaccines licensed in the Russian Federation. It describes the WHO position on preventive vaccination against viral hepatitis B, and pays special attention to vaccination of people at risk. The article considers promising areas for improving immunobiological products for hepatitis B prevention, including new technologies used in vaccine production, development and introduction of new adjuvants or adjuvants systems, and development of therapeutic vaccines.

Poliomyelitis 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.

WHO experts attribute the resurgence of whooping cough to the wide use of acellular pertussis vaccines (aPs) as components of combination products. In this regard, WHO encourages countries that have not yet switched to the use of aPs to continue to use whole-cell pertussis vaccines (wPs) for primary vaccination. The experience of using pertussis vaccines has shown that companies do not always produce highly efficacious products. The use of statistical methods of samples quality control helps to ensure consistency of the technological process, which results in the production of more homogeneous products, and rules out the possibility of producing low-quality products. This paper presents the results of retrospective evaluation of the consistency of the wP (as a pertussis component of the DTP vaccine) production using Shewhart control charts. It was shown that at some points in time during the analyzed period from January 2017 until March 2018 the technological process of the company lacked proper statistical control. This increased the risk of producing non-uniform and defective products. In order to improve the quality and consistency of pertussis component batches, the company’s quality control and quality assurance services should make extensive use of Shewhart charts on a real-time basis.

Currently, the identity of measles, mumps and rubella virus vaccines is determined during certification testing by a labour-consuming, lengthy and costly neutralisation test using cell cultures. The identity of the virus contained in such vaccines is established based on neutralisation of cytopathic effect of viruses in sensitive RK-13 and Vero cell cultures using a specific immune serum. An urgent challenge is to simplify and reduce the cost of controlling the identity of commercial batches of measles, mumps and rubella vaccines using polymerase chain reaction (PCR) tests. The aim of the study was to determine the possibility of viral ribonucleic acid (RNA) detection in these vaccines using reagent kits from different manufacturers for detection of measles, mumps and rubella viruses in clinical material by real-time reverse transcription-PCR (RT-PCR). The article presents the results of the study, which assessed the possibility of using the real-time RT-PCR for testing the identity of measles, mumps and rubella viruses in vaccines. The authors of the study analysed domestically produced and foreign reagent kits intended for detection of measles, mumps and rubella viruses in clinical material. All the studied reagent kits were able to detect RNAs of the above-mentioned viruses in vaccine products. All the reagent kits demonstrated high specificity and could be used to confirm the identity of the measles, mumps and rubella viruses in all the studied vaccines. Commercial domestic reagent kits can be used to determine the identity of rubella vaccines by RT-PCR. However, it is advisable to develop domestic reagent kits for checking the identity of measles and mumps vaccines by RT-PCR. The acceptability of the test results was assessed using the industry reference standards of measles, mumps and rubella viruses activity with certified stable activity values.

The article summarises materials on the certification of the industry reference standard of Schigella sonnei polysaccharide dysentery vaccine (commercial name — Schigellvac). The industry reference standard is used to assess the consistency of the vaccine «Specific activity» testing by passive hemagglutination inhibition assay. A certification programme for the industry reference standard was developed. Samples of the candidate vaccine were tested in terms of the following quality characteristics: «Appearance», «Identification», «Extractable Volume». The test results confirmed that the samples comply with the current requirements of the manufacturer’s product specification file for Schigellvac vaccine. It was determined that the certification parameter — the polysaccharide dilution ratio which results in inhibition of passive hemagglutination in a homologous system — has to fall in the range from 1:128 to 1:512. The following set of standard documents accompanying a scientific/technological product was approved for the industry reference standard No. 42-28-386-2017: passport, patient information leaflet, mockup labels for primary and secondary packaging.

In accordance with the State Pharmacopoeia (SPh) requirements for live plague vaccine, a reference standard has to be used when testing the specific activity and thermal stability of plague vaccine commercial batches in order to assess the consistency and acceptability of the test results. Since there is no international reference standard for plague vaccine, the certification of a new batch of the industry reference standard (IRS) of live plague vaccine in terms of the above-mentioned quality parameters is an urgent challenge. Therefore, a certification programme for the industry reference standard was developed that establishes the design and scope of testing required to obtain statistically significant results. A candidate IRS was represented by a commercial batch of the product meeting the specification requirements for live plague vaccine. The certification parameters were: «Specific activity: microbial cell concentration», «Specific activity: live microbial cell percentage» and «Thermal stability». The article presents the results of the certification of a new batch of the live plague vaccine IRS, detailed evaluation of the candidate IRS in terms of: «Average weight and uniformity of weight», «Loss on drying», and statistical interpretation of the test results. It also summarises the results of the product testing in terms of «Specific activity: immunogenicity». The results of application of the previous batch of the live plague vaccine IRS (OSO 42-28-392-2013) and the results of monitoring the stability of its certification parameters demonstrated that the IRS shelf life could be extended by 6 months relative to the established period (from 2 to 2.5 years). All the certified and additional characteristics are reflected in the official documents for the scientific/technological product — live plague vaccine IRS, OSO 42-28-392-2017: passport, labelling and patient information leaflet.