Sterility is one of the key parameters of biological safety of immunobiological medicinal products. The article traces the history  of the development of sterility test methods for immunobiological  medicinal products from as far back as 1961 and up to the current  requirements laid down in the State Pharmacopoeia of the Russian  Federation, 13th edition. The article provides a detailed analysis of  major approaches to the improvement of medicines quality  evaluation based on this parameter, namely to the choice of: optimal growth media and methods of their evaluation, sensitive test strains, incubation conditions, the number of test samples (i.e., sample size)  required for reliable demonstration of batch sterility; as well as  approaches to the development of a test design that would accommodate specific aspects of production and use of  immunobiological products. The article dwells upon the longstanding use of the sterility testing scheme developed in the national agency for control of immunobiological products — L.A. Tarasevich State  Institute for Standardization and Control of Medicinal  Immunobiological Products. The article analyses the current status of harmonisation of requirements for sterility testing of immunobiological products and other groups of medicines with those of the leading world pharmacopoeias, and prospects of using these requirements in the Eurasian Economic Union.

Flow cytometry is the most common method of identification and quantitation of cell surface markers. Flow cytometry can be used for  cell counting and characterization of cell types and subtypes by  labeling cells with fluorochrome-conjugated monoclonal antibodies.  Manufacturers of human cell-based medicinal products have accumulated significant experience in flow cytometry and  developed a large number of procedures that can be validated and  included into cell products specifications. The present review  summarises the experience gained with the use of flow cytometry for characterization of human cell lines used to develop cell therapy  products. Since all biomedical cell products (BMCPs) have a cellular  component, it will be necessary to use the flow cytometry method for identification testing of BMCPs during evaluation of their quality.

Biomedical cell products (BMCPs) are a new group of biologicals that are based on various cell lines and are used in the treatment of a  wide range of diseases as well as in the field of regenerative  medicine. The quality control of the cellular component in such  preparations is very important at all stages of BMCPs development  and production. Much attention should be given to confirmation of  BMCPs safety because of their specific properties and potential side  effects, including the risk of cancer development. Carcinogenesis  may be attributed to genetic instability of the BMCP cellular  component. A number of cytogenetic methods can be used at the  chromosomal level in order to identify the genetic instability of cells  in a BMCP. Confirmation of the normal karyotype of cells and  identification of various chromosomal abnormalities can be achieved  using both classic cytogenetic analysis methods, such as chromosome banding, and molecular cytogenetic methods based on the use of fluorescent in situ hybridization. Combination of these  methods may provide a reliable estimation of genetic stability of the  cell line in a BMCP, and indirect evidence of absence of malignancy.

This article provides a review on efficacy and safety of tick-borne encephalitis vaccines licensed in the Russian Federation. It highlights  that both Russian and imported tick-borne encephalitis vaccines  demonstrate high immunogenicity, safety and epidemiological  effectiveness in regions with high vaccine coverage. All licensed tick- borne encephalitis vaccines meet interchangeability criteria in terms of  indications for use (with due regard to age limits), medical  contraindications, vaccination schedules, vaccine composition, as well as safety, immunological activity and efficacy parameters. Timely and  specific prophylaxis help reduce the incidence of tick-borne encephalitis  in endemic regions.

Cholera is an acute diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and O139 serogroups. It still remains a major  global healthcare problem. According to WHO, about 100,000 people die from cholera every year, despite the modern methods of  treatment, improvement in the quality of drinking water, sanitation and hygiene. In recent years, oral cholera vaccines have proved an  effective tool for preventing and curbing cholera epidemics.  According to the WHO Ending Cholera — A Global Roadmap, mass  vaccination should help reduce the mortality resulting from cholera  by 90 % worldwide by 2030 and eliminate the disease in 20  countries. The review outlines the main historical stages in the  development of cholera vaccines: parenteral, chemical, inactivated and live oral vaccines. The paper compares active  ingredients and excipients used in Dukoral®, mORC-VAX®, Shanchol®, Euvichol®, Vaxchora®, Oravacs® and the cholera bivalent chemical vaccine. The results of international multicenter clinical trials of oral inactivated, live and  chemical cholera vaccines are analysed. Issues related to efficacy and safety studies of cholera vaccines are considered.

Microorganism resistance to medicinal products and disinfectants reduces the efficacy of prevention and treatment of human infectious diseases, increases the severity and duration of such diseases as  well as the mortality rates, and is therefore regarded as a major  global health issue. With a view to implementing the Russian  National Security Strategy and the Principles of the National Policy in the Sphere of Chemical and Biological Safety of the Russian Federation up to 2025 and beyond, and with due regard to the Concept of the Long-Term Social and Economic Development of the  Russian Federation until 2030 — the Government of the Russian  Federation issued a resolution (in 2017) that approved the Strategy  for Prevention and Combating the Resistance of Microorganisms and  Plant Pests to Medicinal Products, Chemical and Biological Agents up  to 2030 and beyond (hereinafter — Strategy). The Strategy is a federal document that defines the aim and objectives of controlling the biological threat coming from the spread of microorganism and  plant pest resistance to medicines, chemical and biological agents.  The article analyses the aim and objectives of the Strategy, dwells  upon specific features of the document, summarises the main stages and expected results of measures outlined in the document, and  describes some aspects of its implementation.

The 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.