Basic Requirements for the Procedure for Maintaining Collections of Industrial Strains of Bacteriophages

The development and implementation of biological drugs based on bacteriophages is one of the elements of the “Strategy for Preventing the Spread of Antimicrobial Resistance in the Russian Federation for the Period of up to 2030”, approved by the Decision of the Government of the Russian Federation, dated September 25, 2017 No. 2045-r. A prerequisite for the implementation of the objectives of the Strategy is the creation of banks of hospital strains of microorganisms and banks of relevant bacteriophages. The aim of the work was to determine the basic requirements for the procedure for maintaining a collection of industrial strains of bacteriophages. Materials and methods. An analysis of regulatory documents has been carried out, where goals, objectives, rules for the creation and use of collections of pathogenic microorganisms and viruses are stated, and the requirements for the quality of therapeutic and prophylactic preparations of bacteriophages are set. Information materials containing up-to-date information on the biological properties of bacteriophages that are important for their therapeutic use are considered. Results and discussion. Maintaining a production collection of bacteriophages is characterized by certain features that must be taken into account when crea ting therapeutic and prophylactic preparations of bacteriophages that correspond to the current dynamics of variability of clinical bacterial strains. To ensure the clinical efficacy and genetic safety of phage therapy, bacteriophage preparations should contain bacteriophages that are identified and characterized by morphological, biological, and genetic features. Bacteriophage preparations should be adapted to epidemiologically significant pathogens of purulent-inflammatory and intestinal infections.

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