Biobanking standardization in Russia: assessment of the implementation, challenges and prospects
https://doi.org/10.15829/1728-8800-2025-4575
EDN: ZUKTPU
Abstract
Aim. To assess the implementation of international standards in Russian biobanking — members of National Association of Biobanks and Biobanking Specialists (NASBIO), as well as the willingness and interest of specialists in certification and accreditation of Russian biobanks.
Material and methods. To assess the level of standardization of Russian biobanks in June 2025, a questionnaire was developed consisting of four sets of questions on biobanking standardization, the implementation of quality management systems, and the prospects for certification. A survey was conducted from July to August 2025 among representatives of Russian biobanks — NASBIO members. Descriptive statistics were used to analyze the survey results.
Results. Representatives of 20 organizations participated in the survey. All participants provided written consent to personal data processing. The majority of survey participants represented biobanks established at state research and medical institutions. The survey results showed that Russian biobanks apply and actively implement mandatory quality management procedures. However, only four biobanks are certified according to the International Organization for Standardization (ISO) 9001 standard. High interest among specialists in obtaining ISO 20387 certificates of conformity was noted.
Conclusion. The survey results showed that Russian biobanking specialists generally demonstrate a commitment to quality and an interest in standardizing biobank operations. The lack of a clear legal framework in Russia for research biobanks of human samples and accredited bodies for biobank certification according to ISO 20387 remain limiting factors for the exchange of collections and their shared use in research and development.
Supporting agencies: Relationships and Activities. State assignment "Circulating MicroRNAs in Plasma as Diagnostic and Prognostic Biomarkers of CAD"
About the Authors
A. L. Borisova
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Petroverigsky Lane, 10, bld. 3, Moscow, 101990
A. N. Meshkov
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Petroverigsky Lane, 10, bld. 3, Moscow, 101990
M. S. Pokrovskaya
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Petroverigsky Lane, 10, bld. 3, Moscow, 101990
V. A. Metelskaya
National Medical Research Center for Therapy and Preventive Medicine; Russian Medical Academy of Continuous Professional Education
Russian Federation
Russian Federation
Petroverigsky Lane, 10, bld. 3, Moscow, 101990; Petroverigsky Lane, 10, bld. 3, Moscow, 101990
O. M. Drapkina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Petroverigsky Lane, 10, bld. 3, Moscow, 101990
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Supplementary files
What is already known about the subject?
- An integrated approach to management and standardization are effective tools for maintaining the stable operation of a biobank and ensuring the quality of biomaterial.
- International and Russian experts have created a regulatory framework that allows biobanking standardization and harmonization and the improvement of biomaterial quality for research and biomedical development.
What might this study add?
- For the first time in Russia, a study was conducted to examine the extent to which international biobanking standards are being implemented in Russian biobanks. The survey results are presented, including data on operation standardization, the implementation of sample quality control procedures, and risk management. An assessment was made of the level of interest among specialists and the readiness of Russian biobanks for certification according to ISO 9001 and ISO 20387.
Review
For citations:
Borisova A.L., Meshkov A.N., Pokrovskaya M.S., Metelskaya V.A., Drapkina O.M. Biobanking standardization in Russia: assessment of the implementation, challenges and prospects. Cardiovascular Therapy and Prevention. 2025;24(11):4575. (In Russ.) https://doi.org/10.15829/1728-8800-2025-4575. EDN: ZUKTPU
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