K.A. Kotegova1, M.P. Kostenko2, B.G. Kotegov3, Yu.I. Pigareva4

1,2,4 Federal State Budgetary Scientific Institution “All-Russian Scientific Research and Technological Institute of Biological Industry” (Losino-Petrovsky, Moscow region, Russia)

1,2,4 Federal State Enterprise “Shchelkovo biocombinat” (Losino-Petrovsky, Moscow region, Russia)

3 Federal State Autonomous Educational Institution of Higher Education “Moscow Polytechnic University” (Moscow, Russia)

3 “All-Russian Scientific Research Institute of Fisheries and Oceanograph” (Moscow, Russia)

1 kotegovaka@biocombinat.ru, 2 kostenkomp@biocombinat.ru, 3 rutilus@yandex.ru, 4 pigarevaui@biocombinat.ru

The production of vaccines for veterinary use is a process based on the manipulation of microorganisms, requiring the development and implementation of special biological safety measures at each stage of production. A risk-based approach provides a deeper understanding of biosafety and biosecurity processes, and the use of risk assessment results is necessary to develop measures to control and reduce the level of risk to acceptable values. This article focuses on the use of risk management techniques to identify and quantify biological risk factors and develop mitigation and control measures. Biological industry enterprises are faced with the identification of unique, characteristic only for them, problems associated with biorisk. Therefore, the results of the biological risk assessment and the measures used to control it may differ significantly for different enterprises and be detailed depending on the technologies used at the enterprise for the production of vaccines and biological agents. And the developed measures to reduce and control biorisk are aimed at eliminating the identified causes, are based on scientific data (with confirmed effectiveness by peer-reviewed studies) and are provided with the available resources of the enterprise, do not contradict the current regulatory requirements (legislative requirements of the national/federal, regional/regional, city and local level) and do not provoke additional risks. Thanks to these principles, the selected measures are effective and efficient in implementation. The authors have shown that the risk analysis system is simply integrated into the company's quality systems that use risk management principles.

Kotegova K.A., Kostenko M.P., Kotegov B.G., Pigareva Yu.I. Evaluation of bioriscs on the production of veterinary vaccines. Technologies of Living Systems. 2026. V. 23. № 2. Р. 100-106. DOI: https://doi.org/10.18127/j20700997-202602-10 (In Russian).

1. Simonova E.G., Saburova S.A., Levina K.Yu. et al. Sovremennaya situatsiya i osnovnye napravleniya borby i profilaktiki beshenstva v Rossiyskoy Federatsii. Lechashchiy Vrach. 2019. № 6. S. 74-76. DOI: 10.26295/OS.2019.72.95.016 (in Russian).
2. Shubina E.G., Grudev A.I., Drugova O.P. et al. Kontrol soderzhaniya antibiotikov tetratsiklinovoy gruppy v produktakh pitaniya na territorii Rossiyskoy Federatsii. Veterinariya Kubani. 2021. № 1. S. 22-25. DOI: 10.33861/2071-8020-2021-1-22-25 (in Russian).
3. O biologicheskoy bezopasnosti v Rossiyskoy Federatsii. Federalnyy zakon ot 30.12.2020 g. № 492-FZ (s izmeneniyami na 23 iyulya 2025 goda). (in Russian).
4. Sanitarno-epidemiologicheskie trebovaniya po profilaktike infektsionnykh bolezney. SanPiN 3.3686-21. (in Russian).
5. Gigienicheskie normativy i trebovaniya k obespecheniyu bezopasnosti i (ili) bezvrednosti dlya cheloveka faktorov sredy obitaniya. SanPiN 1.2.3685-21. (in Russian).
6. O sostoyanii sanitarno-epidemiologicheskogo blagopoluchiya naseleniya v Rossiyskoy Federatsii v 2023 godu. Gosudarstvennyy doklad. El. publikatsiya na sayte: https://www.rospotrebnadzor.ru/documents/details.php?ELEMENT_ID=27779 (in Russian).
7. Solórzano-Álvarez E., Pérez-Tortoló J., Rodríguez-Dueñas J. Evaluación del riesgo biológico en la producción de vacunas inactivadas de uso animal. VacciMonitor. 2020. V. 29. № 3. P. 93–102.
8. Sistemy menedzhmenta organizatsiy. Rekomendatsii po postroeniyu integrirovannykh sistem menedzhmenta. GOST R 55269-2012. (in Russian).
9. Prakticheskie aspekty menedzhmenta riska. Menedzhment bioriska. GOST R 55234.2-2013. (in Russian).
10. Chernysheva G. Osnovy integratsii sistem menedzhmenta. Sluzhba Kachestva (onlayn-zhurnal). 2021. № 1. S. 26–29. (in Russian).
11. Kotegova K.A., Eremets N.K. Upravlenie riskami dlya kachestva kak element obespecheniya kachestva, bezopasnosti i effektivnosti lekarstvennykh sredstv dlya veterinarnogo primeneniya. V kn.: Sovremennye dostizheniya v reshenii aktualnykh problem agropromyshlennogo kompleksa. Minsk. 2022. S. 256–259. (in Russian).
12. Orekhov D.A., Kashtanova D.V. Pravovye osnovy analiza riska v veterinarii. Uchenye Zapiski Kazanskoy Gosudarstvennoy Akademii Veterinarnoy Meditsiny im. N.E. Baumana. 2018. V. 236. № 4. S. 146–150. DOI: 10.31588/2413-4201-1883-236-4-146-150 (in Russian).
13. Pukhova N.M., Girsh T.A., Shubina E.A., Eremets N.K. Metodologiya analiza riskov v proizvodstve kulturalnykh protivovirusnykh vaktsin. V kn.: Aktualnye problemy veterinarnoy meditsiny. Kazan. 2018. S. 255–259. (in Russian)
14. Menéndez de San Pedro J.C., Santos L.G., Hernández L.A. et al. Manual de Inspección de Seguridad Biológica. La Habana. Cuba: Editorial Academia. 2005.