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The research biobanking field is developing rapidly in Russia. Over the course of the last decade, numerous biobanks were created or formed from existing collections of human and environmental biospecimens. The Russian National Association of Biobanks and Biobanking Specialists (NASBIO) was established in December 2018, aiming to: (1) unite professionals and research centers to create and develop a network of biobanks in Russia; (2) provide services and expertise in the field of biobanking; (3) execute various research projects utilizing biobanks' infrastructure; and (4) facilitate integration of Russian biomedical research centers into global research activities. The organizational structure, aims, and plans of this newly formed national association are reviewed in this article. The founders of NASBIO hope that the association will promote further development of biobanks and their networking in Russia, which is critically important for the success of national biomedical, pharmaceutical, and biotechnological research, and can facilitate international biobanking projects on a global scale.

Taking into account the impact of shipment method of biosamples is necessary for obtaining high-quality biological samples in biobanking and laboratory research. The impact of liquid nitrogen, dry ice and cold accumulators on the quality of biological markers was considered, as well as recommendations to reduce the impact of these methods of shipment. The liquid nitrogen provides the best preservation of samples, however, dry ice is used much more often during their transportation. When transporting certain types of cells using dry ice, there is the way to use CryoStor CS1 and Cell Banker 1 cryoprotectors. The dry ice has a significant effect on both the pH of liquid biological samples and the coagulological parameters of plasma samples. The penetration of CO2 into the sample leads to changes in the parameters of PTT and APPT, as well as to decrease the protein C and fibrinogen level under certain conditions. Serum and plasma samples exposed to dry ice for more than 16 hours should be thawed open at room temperature, or instead of it should be kept at -80 °C for 24 hours to avoid changes in coagulation parameters, The use of cold accumulators is unacceptable for long-term shipment of serum and plasma containing unstable biomarkers because of insufficiently low temperature (increase over time to -25 °C and above). Besides, metal pellets can be used as cold storage batteries at low temperatures (up to -80 ° C), but they are not as effective as dry ice, since it is able to hold the required temperature for much longer., Competing Interests: The authors declare no conflict of interest.

Currently one of the most important problems facing biobanking specialists is the standardization of biobanks operation. Close attention is paid to this issue by international biobanking organizations, such as ISBER and BBMRI-ERIC, which develop regulatory documentation in this area. The article provides examples of standardization tools - implementation of the ISO 9001 quality standard and ISBER Best Practices. General information about the development, scope, and structure of the ISO 20387 standard is provided. The standard does not provide ready-made solutions and does not contain specific requirements for storage temperature or biosamples processing in biobanks, allowing each biobank to adapt its own management system to existing conditions and needs. The standard contains requirements for both the organization of the biobanking and the supporting processes - personnel competence; requirements for biological safety; infrastructure management, including equipment used by the biobank, environmental parameters that affect the storage of biomaterial. The standard contains requirements for the quality management system of biobank, as a necessary element of the organization of any biorepository. At the initiative of the Russian National Association of biobanks and biobanking specialists (NASBIO), development of the Russian standard GOST R ISO 20387 «Biotechnology. Collection and storage of biological samples in biobanks. General requirements» is included in the plan of the National Standardization Program for 2020 by order of Rosstandart No. 2612 of 11/01/2019. Implementing quality standards is a long and painstaking process that requires the involvement of all employees and certain resources. However, the effectiveness of strict compliance exceeds the cost of developing, implementing and maintaining management systems, as it significantly increases the confidence of researchers in the work of biobanks, guarantees high quality of biospecimens and associated data, and creates opportunities for cooperation, both at the national and international level, based on the application of common quality standards in the work., Competing Interests: The authors declare no conflict of interest.

The National Medical Research Center for Preventive Medicine of Russia (NMRCPM) conducts epidemiological and clinical research for the development of personalized medicine. This is why NMRCPM has faced the problem of how to standardize preanalytical conditions for all biospecimens from various scientific projects and of how to provide long-term responsible standardized regulated safe storage of blood and its derivatives. This article describes various aspects of establishing a biobank in a large medical center dedicated to integrating the biomarkers research activities of different departments. To date, >205,000 serum/plasma/whole blood specimens have been stored. Collaboration with >25 scientific projects as well as the biobank's own research project has been organized. The availability of this biobank became a platform for the establishment of the Personalized Medicine Center in NMRCPM.

The biobank is a structure established with the goal of long-term responsible storage of biological samples and the associated data for their further use in scientific and clinical research. The objectives of biobanking are the creation of unified recommendations on: the planning of premises and the selection of equipment for storage; development of management methods and staff training; standardization of methods for the collection, shipping, processing and storage of biomaterial of various origins, as well as methods for quality control and validation of the applied methods; creation and use of databases of information accompanying biospecimens. The lack of common standards for conducting the preanalytical phase has been the cause of low accuracy and poor reproducibility of research results. To date, a large number of guidelines and best practices have been published that provide an answer to a wide range of problems in organizing the biobanking process. The article provides an overview of the most famous biobanking guidelines that can be used to solve various research problems. Biobanking in Russia is actively developing. Since 1996 there is a work on the legislative regulation of biobanking activities, as a result of which a number of regulatory documents have been issued. An important stage in the development of biobanking in Russia was the establishment of the "National Association of Biobanks and Biobanking Specialists" (NASBio) in 2018, which included representatives of medical and research institutions, commercial firms, and qualified specialists in the field of biobanking. One of the key tasks of NASBio is the adaptation and implementation of the best biobanking practices in Russian research institutes and centers. The use of modern guidelines and best practices on biobanking will lead to an increase in the quality of research and publications., Competing Interests: The authors declare no conflict of interest.

This paper provides several definitions of the term "biobank"; a list of standards developed by the International Organization for Standardization (ISO) applicable to the activities of biobanks; analyzes the legal and ethical requirements; the Russian legal framework in the field of biobanking, the best international practices and recommendations; describes the experience of the development and implementation of quality management systems according to ISO 9001 in Biobanks established in different countries, and the experience of the Bank of Biological Material of the National Medical Research Center for Preventive Medicine of the Ministry of Healthcare of Russia. The ISO 20387 Biobanking Standard, released in August 2018, combined the knowledge and experience of specialists from around the world and defined the general requirements that must be fulfilled by biobanks and repositories wishing to guarantee their customers the high quality of the preanalytical stage of scientific research, biological samples and associated data. In 2019, the Russian version of this standard is expected. Documents of the quality management system provide the reproducibility of activities on the main storage processes and facilitates the process of incorporating a new employee; conducting internal and external audits; Biobank knowledge management - continuous staff education. The introduction of an effective quality management system into biobank activity warrants the high quality of biological samples, the standardized pre-analytical stage, reliable, regulated long-term storage of biomaterial and related information for use in research purposes today and in future., Competing Interests: The authors declare no conflict of interest.