The analysis of the use of the method for the evaluation of specific (immunogenic) activity of vaccines for preventing tick-borne encephalitis (TBE vaccines) against protective dilution (PD₅₀) and the minimum immunizing dose (MID₅₀) has been performed. The method was standardized and submitted to the regulatory documents for TBE vaccines authorized in the Russian Federation. When analyzing the results of the study of specific (immunogenic) activity of TBE vaccines (107 TBE vaccine batches by different manufacturers have been studied) it was confirmed that the choice of real lethal dose (RLD₅₀) indicator of TBE virus (test strain «Absettarov») in the range of 100-3000 LD₅₀, the reasonability of using BALB /c cell-line mice, the effectiveness of the national method of determining immunogenicity in terms of MlD₅₀ for TBE vaccines authorized in the Russian Federation. The reasonability of using immunogenicity reference standard for TBE-OSO 42-28-48 to assess the reproducibility of the experiments, and the homogeneity of laboratory animals in terms of quality. Methods for determining TBE vaccine immunogenicity («specific activity (immunogenicity)» in terms of PD₅₀ and MID₅₀ is applicable both for Russian commercial TBE vaccines and for FSME-Immun vaccine, manufactured by «Baxter Vaccine AG», Austria.

Hepatitis A (HA) is an acute infectious disease of the liver caused by the hepatitis A virus (HAV). HA disease incidence rate is closely linked to the social and economical development. The results of seroepidemiologic studies show that the prevalence of anti-HAV antibodies in population ranges from 15 to almost 100% in various countries of the world. The only reliable way to prevent hepatitis A virus (HAV) for today is the specific prophylactic vaccination. Recently developed inactivated vaccines against HAV have been successfully used in many countries. Vaccines authorized in Russia are safe, possess low reactogenicity and high immunogenicity. Practical experience in using vaccines during the outbreaks of HAV has shown that they possess epidemiological efficacy and provide necessary protection of the population in extreme conditions. This is clearly confirmed by single administration of vaccines to patients in epidemic focus of HAV. Constant regular monitoring of the duration of protection induced by one and two doses of the vaccine is required. The article considers WHO’s position on the use of vaccines for the prevention of HA. It describes the prospects of the further use of vaccines to control the spread of HA.

Preparations of recombinant human erythropoietin (rhEPO) are included in the list of vital and essential drugs for medical use. When evaluating the quality of EPO preparations during the manufacturing process, under the state marketing authorization and certification procedures, in order to confirm their quality in terms of assay (specific activity), identification, dimer and high-molecular related substances content, sialic acids, it is required to use erythropoietin reference standard. The present article describes various stages of the development of erythropoietin reference standards. It provides the comparative description of the existing methods for evaluating the quality of erythropoietin preparations using reference standards. The necessity of the development and validation of national erythropoietin reference standard is justified.

The present article describes the scientific and methodological development of biotechnological manufacture of test-system components (diagnostic preparations) for instant diagnosis of plague, brucellosis, tularemia, anthrax, cholera. In this regard, in the first place the effective methods for obtaining complete antigenic complexes used for immunizing animals for the purpose of developing highly potent immune sera have been established. These antisera were used in determining optimum parameters of manufacture on the basis of their diagnosticums. Methodical basis of developing magnetic immunosorbents for selective concentration of infectious agents and their instant diagnosis methods has been mentioned. Moreover, the article describes the development of piezoelectric quartz crystal biosensors to detect plague, brucellosis and tularemia pathogens by gravimetric flow injection analysis, allowing to quickly implement the process of reliable identification of a test pathogen in antigen-antibody complex.

Perfusion cultivation process for CHO cells producing recombinant B-domen deleted coagulation factor VIII was developed. Cell culture medium and feed supplement were optimized by screening of big panel of prototype media and supplements. Cultivation temperature was optimized for better expression of complex protein as well. Cultivation process was tested in a laboratory-scale perfusion bioreactor. Significant increase of productivity was shown as a result of the development.

The article presents the results obtained in the study of a new batch of a candidate branch reference standard for live tularemic vaccine (vaccine BRS). The candidate vaccine BRS was represented by a commercial batch of a product that met all applicable requirements of the manufacturer’s monograph (MM) for live tularemic vaccine’s quality attributes. The candidate vaccine BRS was certified for specific activity including a range of parameters, such as: microbial cells concentration, percentage of living microbial cells, dissociation degree (percent of SR (white) immunogenic colonies from the total number of colonies grown), as well as immunogenicity. Results of analysis that addressed the use of this batch of vaccine BRS and its quality attributes made it possible to extend the shelf-life of the product for 6 months.

The article summarizes the new microbiological culture media produced in FSIS SRCAMB to improve the efficiency of diagnosis of infectious diseases, describes the advantages of these environments compared to foreign analogs, technological achievements in the field of drug development.

The 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.

The paper presents the results of identification of a spectrum of biochemical activity and certification of 140 bacterial strains of I-II risk level deposited in the State collection of pathogenic microorganisms of Scientific centre for expert evaluation of medicinal products of the Ministry of health of the Russian Federation. Causative agents of meningitis, dysentery, salmonellosis and other acute gastrointestinal, pyoinflammatory infections, including nosocomial, and other epidemiologically significant infections which can be applied for manufacturing and an quality assessment medicinal and diagnostic preparations, including vaccines, toxoids, therapeutic and prophylactic bacteriophages, antimicrobic drugs, diagnostic serum, test system, nutrient media were evaluated. Correction of a taxonomic nomenclature of collection strains according to requirements of Bergey’s manual of systematic bacteriology (2^nd ed) was provided. A possibility of selection of the analogs of cultures of the microorganisms deposited in national collections of other countries and applied by production and quality control of immunobiological medicines and also for quality assessment of laboratory researches is proved. Stability of pivotal phenotypic properties and lack of dissociation master-seed and test strains is confirmed at freeze-drying for over 40 years.

Therapeutic and antiviral efficacies of inhalations of aerosolized aprotinin, a protease inhibitor, which blocks a stage of influenza virus proteolytic activation, were studied. This clinical study was performed during winter-spring outbreak caused with pandemic Influenza H1N1pdm09. Aprotinin (a natural low molecular weight antiprotease polypeptide) is known to be a chemotherapeutic antiviral drug, which inhibits influenza virus proteolytic activation accomplished by host respiratory proteases. Patients inhaled 2 aerosol doses of aprotinin (160 Kallikrein-inhibiting Units (KIU)) each 2 hours for 5 days. In comparison group, patients were treated with ingavirin (a synthetic peptidoamine with unknown antiviral target), 90 mg per day for 5 days. About 10-fold decrease of virus load in aprotinin patients were determined in comparison to ingavirin patients. Duration of clinical symptoms, such as rhinorrhea, weakness, headache, sore throat, cough, sore thorax, fever, was 1 -2 days shorter in aprotinin then in ingavirin group. Side effects and patient discomfort were not revealed in aprotinin group patients. Aerosolized form of aprotinin can be recommended as a pathogenetic antiviral drug against Influenza caused by different viruses, including seasonal H1N1, H2N2, H3N2, swine-like H1N1pdm09, and avian-like H7N9 viruses.