Basic Requirements for the Procedure for Maintaining Collections of Industrial Strains of Bacteriophages
https://doi.org/10.21055/0370-1069-2024-4-146-149
Abstract
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.
Keywords
About the Authors
D. S. DavydovRussian Federation
Dmitry S. Davydov
8, Bld. 2, Petrovsky Boulevard, Moscow, 127051
R. L. Parfenyuk
Russian Federation
8, Bld. 2, Petrovsky Boulevard, Moscow, 127051
Z. V. Durmanova
Russian Federation
8, Bld. 2, Petrovsky Boulevard, Moscow, 127051
A. A. Movsesyants
Russian Federation
8, Bld. 2, Petrovsky Boulevard, Moscow, 127051
References
1. Zurabov A.Yu., Karkishchenko N.N., Popov D.V., Zhilenkov E.L., Popova V.M. [Creation of native bacteriophages collection and principle of treatment and prophylactic phage drug design]. Biomeditsina [Biomedicine]. 2012; (1):134–8.
2. Myakinina V.P., Volozhantsev N.V., Denisenko E.A., Govorunov I.G. [Database “Collection of bacteriophages of FBSI SSC AMB”]. In: [Proceedings of the V National Congress of Bacteriologists. Moscow, September 16–17, 2019 / Associated National Scientific-Practical Society of Bacteriologists]. Moscow: Dynasty Publishing House; 2019. P. 58–9.
3. Pharmaceutical Holding “National immunobiological enter- prise” creates an all-Russian base of bacteriophages. (Cited 12 Sept 2023). [Internet]. Available from: https://rostec.ru/news/4521345/.
4. Polygach O.A., Voroshilova N.N., Tikunova N.V., Morozova V.V., Tikunov A.Yu., Krylov V.N., Yunusova A.A., Dabizheva A.N. [Modern approaches to methods for creating a phage base for a thera- peutic and prophylactic preparation of bacteriophages Pseudomonas aeruginosa]. Epidemiologiya i Vaktsinoprofilaktika [Epidemiology and Vaccinal Prevention]. 2018; (2):37–45. DOI: 10.24411/2073-3046-2018-10004.
5. [Production, quality, preclinical, clinical trials of thera- peutic and prophylactic preparations of bacteriophages]. In: [Regulatory Legal Acts in the Field of Circulation of Medicines within the Framework of the Eurasian Economic Union. Volume 3. Development and Conduct of Research on Biological Medicines]. Moscow: “Remedium”; 2017. P. 341–52.
Review
For citations:
Davydov D.S., Parfenyuk R.L., Durmanova Z.V., Movsesyants A.A. Basic Requirements for the Procedure for Maintaining Collections of Industrial Strains of Bacteriophages. Problems of Particularly Dangerous Infections. 2024;(4):146-149. (In Russ.) https://doi.org/10.21055/0370-1069-2024-4-146-149