Aim. To create the concept of the national information platform of biobanks of the Russian Federation (NIPB RF).

Material and methods. In April 2022, an expert group consisting of 17 representatives of Russian biobanks was formed in National Association of Biobanks and Biobanking Specialists to create the concept of the NIPB RF. An analysis of international practices in this area was carried out. To assess the infrastructure of Russian biobanks in terms of information support for stored biomaterial, experts formed a questionnaire consisting of several blocks of questions. The survey was conducted from April to June 2022 among representatives of Russian biobanks. Descriptive statistics were used to analyze the results of the survey.

Results. In total, representatives of 16 biobanks took part in the survey. The storage capacity of biobanks varies from 2000 to 800000 storage units. It is shown that the majority of biobanks (81%) use information systems for entering and storing related data. Biobanks use foreign and Russian software products (53 and 47%, respectively), while a  third develop their own information systems. We formulated the NIPB RF concept as an information system designed for consolidating, processing and using data on biosamples for the development of Russian biobanking and improving the efficiency and quality of research.

Conclusion. The creation of the NIPB RF will improve the interaction between biobanks and end users and will develop biomedicine in Russia.

The formation of biobanks in the structure of scientific and treatment and diagnostic institutions with prospects for interregional integration is a fundamental link in monitoring and predicting diseases of various origins, creating and testing highly effective diagnostics, and developing novel therapeutic agents.

Aim. To describe standard operating procedures and principles for the formation of bioresource collections (BRC) in medical institutions with biobanking.

Material and methods. The data of scientific and practical biomedical projects using BRC obtained from patients with genetic, multifactorial and infectious diseases in St. Petersburg and Surgut are presented. As of September 2022, the BRC collected on the basis of the Pediatric Research and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency includes biosamples from 1619 patients, and the BRC collected in the Medical Institute of Surgut State University includes biosamples from 450 patients and healthy individuals of different sex and age. The selection of biosamples from apparently healthy individuals and patients with various diseases can serve as a strategically important resource for future research in terms of etiology, epidemiology, the development of regulatory environment and scales, innovations in the development of diagnostic approaches and treatment of the Russian population.

Aim. To determine the reference ranges of concentrations of 38 cytokines, chemokines and growth factors, as well as to measure the content of these analytes in patients with neurodegenerative and cardiovascular diseases (CVDs) using biomaterial from the biobank repository.

Material and methods. The study included 303 serum and plasma samples from 281 healthy donors, 242 samples from 224 patients with neurodegenerative diseases, and 164 samples from 152 patients with CVDs from the biobank of the of St. Petersburg City Hospital № 40. In  all samples, the concentration of 38 cytokines, chemokines, and growth factors was determined by multiplex immunofluorescence assay.

Results. Based on the measured concentrations in the group of healthy donors, non-parametric 95% reference ranges with 90% confidence intervals were calculated. For the majority of analytes, no sex and age differences were observed. In donors >65 years of age, the concentration of macrophage inflammatory protein-1-α was reduced and the levels of interleukin-8 and the chemokine interferon-inducible protein 10 were increased. Young donors (18-35 years) had lower levels of tumor necrosis factor-α. In groups with neurodegenerative and cardiovascular diseases, multiple deviations from the calculated reference values were found.

Conclusion. Certain reference intervals are intended to evaluate the concentrations of cytokines, chemokines and growth factors determined in blood serum or plasma using Human Cytokine/Chemokine Magnetic Bead Panel 1 reagents (Merck, Millipore) on the MAGPIX system and do not imply a direct transfer to other analytical methods.

Risk management is a key aspect of the organization and management of biobanks, which is part of the overall quality management system aimed at early detection, analysis and minimization of events, that can lead to negative consequences for the biobank, as well as affect the quality of biosamples and related data. The article presents the biobanking risk classification with the description of each category.

Aim. To develop and implement the methodology for identification, analysis, evaluation and development of risk management measures for the biobanking process in the biobank of the National Medical Research Center for Therapy and Preventive Medicine.

Material and methods. We present the methodology of the risk management process developed on the basis of the literary data, world experience and experience of the biobank of the National Medical Research Center for Therapy and Preventive Medicine.

Results. The biobanking risk management procedure was developed and implemented in the biobank of the National Medical Research Center for Therapy and Preventive Medicine in 2020. The work carried out made it possible to identify, analyze and evaluate a wide range of potential negative events and actions that could lead to biobank damage, both in the form of financial losses and ethical and technical issues related to the biobanking process. A significant reduction in the frequency of emergency events and the high stability of the biobank operation under the influence of various external factors prove the effectiveness of the approach used.

Conclusion. The creation and maintenance of a risk management system in the biobank allows, in combination with other measures, to ensure the safety and high quality of the procedures for collecting, processing and long-term storage of biomaterial and related data by creating an environment that rules out or minimizes the impact of various risks.

The Biobank of the National Medical Research Center of Oncology is a multi-layered infrastructure with large collections of biological samples, complemented by extensive and well-annotated clinical and pathological patient data, including medical images, pathological histology, and molecular analysis of biosamples. To date, the biobank of the National Medical Research Center of Oncology contains collections of primary and immortalized cancer cell lines of human origin. The collection of primary cell lines was formed from samples of postoperative material taken during the removal of tumors of various localizations (breast cancer, prostate cancer, lung cancer). All cell lines underwent internal quality control for contaminants (exogenous viruses, mycoplasmas and bacterial L-forms), viability and were cultivated without antibiotics. On the basis of the collected samples, a significant number of projects in the field of biomedicine were carried out, the results of which are described in this article.

Aim. Clinical and anamnestic characterization of the bioresource collection of biosamples from pregnant women at different gestational ages.

Material and methods. Preparation of biosamples of various biomaterial types for long-term storage; static analysis of clinical and anamnestic characteristics of women whose samples are included in the collection.

Results. As of September 1, 2022, the collection consists of 16625 biosamples of various biomaterial types from 355 pregnant women. The clinical and anamnestic characteristics of women, samples of which are presented in the collection, are presented.

Conclusion. The resulting high-quality biosamples can be used in various basic and applied research to study both the physiological and pathological course of pregnancy. Particularly promising is the possibility of searching for the earliest biomarkers of gestational complications before the onset of obstetric complications. In this regard, it is important to have complete clinical and anamnestic data on biosamples of the collection in order to expand the possibilities of its use and improve the quality of ongoing research.

Aim. To approve the COrDIS kit (Gordiz, Russia) for the authenticity of cell lines from the Bioresource Collection of the N.N. Blokhin National Medical Research Center of Oncology by the short tandem repeat (STR) profiling.

Material and methods. The chosen method proved to be a reliable and reproducible option. With this approach, a number of polymorphic STR loci are amplified using commercially available primer sets. Polymerase chain reaction (PCR) products are analyzed simultaneously with size standards using automated fluorescent detection methods. The results are presented as a simple number code corresponding to the lengths of the PCR products amplified at each locus. By applying this method to cell lines, the laboratory can both authenticate commercial cell lines and build a database of their lines. In the work, we used the COrDIS EXPERT 26 kit (Gordiz, Russia), validated for molecular genetic identification of personality based on multiplex PCR analysis of 26 highly polymorphic loci of human genomic deoxyribonucleic acid. PCR results were analyzed by capillary electrophoresis using an automatic genetic analyzer with laser-induced fluorescence detection (Applied Biosystems 3500xL).

Results. When testing the method, profiling of 37 cell lines was carried out, of which 18 were announced in international databases and 19 were unique, obtained at the N. N. Blokhin National Medical Research Center of Oncology, as well as a cell line mixture in order to determine the limits of contamination detection. The obtained results showed the correspondence of commercial cell lines with the data in international databases. Within the framework of this work, profiles of unique lines were obtained and the foundation of own genetic database was laid. Studies to identify the limit of contamination detection by another line have shown that even 4% of the contaminant culture in the total pool can be used to identify its individual alleles.

Conclusion. The results obtained indicate the possibility of using the method to identify samples of the collection and detect intraspecific contamination.

Aim. To create and validate an algorithm for automatic aliquoting of serum and plasma samples for biobanking as part of a large-scale study.

Material and methods. Biobank of the National Medical Research Center for Therapy and Preventive Medicine is equipped with a Tecan automated aliquoting system. When compiling the aliquoting program (script), the following parameters were selected: the time spent on spotting one complete cryobox, with a capacity of 96 cryotubes, the optimal number of vacutainers and tips for a single loading of the device. The program was created to receive 12 aliquots of 0,5 ml of blood serum, plasma with ethylenediaminetetraacetic acid and plasma with sodium citrate in cryotubes per 1 ml from eight participants in total from each in one cycle of device loading. Automatic and manual spotting was assessed in terms of the time spent on sample preparation and the quality of the aliquots obtained.

Results. A methodology for conducting the preanalytical phase of a  large-scale study based on the automation of biosample aliquoting has been developed and validated. We created scripts for aliquoting serum and blood plasma at the automated Tecan Freedom EVO system. An experiment conducted on biomaterial from 64 participants showed, that with an expected flow of 32 participants per day, it took more than 2 hours for manual aliquoting, and for automatic aliquoting (4 launches of the aliquot robot for 24 vacutainers from 8 participants) — less than 1,5 hours with the complete exclusion of human errors.

Conclusion. Automated aliquoting has a following number of advantages in comparison with manual: it allows to guarantee standardization and efficiency of sample preparation, reduce the time and increase the accuracy of aliquoting of biomaterial, save space in long-term storage freezers due to the use of smaller cryotubes. The developed algorithm for creating aliquoting programs and calculating the optimal use of consumables can be used in other projects.

Aim. To assess the safety of IgG antibodies during long-term storage of blood serum samples using measles- and rubella-specific antibodies as an example.

Material and methods. The study used serum samples from the collection of the Department of Epidemiology of the Gamaleya National Research Center for Epidemiology and Microbiologya, which were tested for measles- or rubella-specific IgG antibodies immediately upon admission to the laboratory, were frozen and stored at -70^оC (n=180). The samples were reexamined after 20 months (n=90) and 6 years (n=90).

Results. Reexamination after 20-month storage showed a decrease in the mean level of measles- and rubella-specific antibodies by 13,1% (from 0,36 (0,08-1,21) to 0,31 (0,02-1,2) IU/ml) and by 11,8% (from 151,4 (45-235) to 133,5 (72-198) IU/ml), respectively (p<0,05 for all). At the same time, the number of seronegative samples did not change. After a 6-year storage period, the mean level of measles-specific antibodies decreased by 33,8% (p<0,05) from 0,72 (0,4-1,79) to 0,34 (0,18-1,14) IU/ml and only two samples became seronegative. It was shown that the higher the IgG level in native samples, the more pronounced its decrease was during the second examination.

Conclusion. Storage of serum samples in a biobank for 20 months at -70^оC ensures the safety of measles- and rubella-specific IgG antibodies, and is the basis for the reliability of future studies.

Biobanking is an actively developing scientific area that provides tools for conducting biomedical research, increasing the reliability and reproducibility of their results. In endocrinology, more and more attention is paid to the study of molecular and genetic markers of diseases for the selection of new points of influence in treatment, the development of targeted therapy and a strategy for personalized prevention. This approach is designed to solve the problems of endocrine disorders, their complications, causing significant damage to the individual and he population health, and reduce the financial burden of chronic endocrine disorders. To increase the reliability and reproducibility of research results, requirements for working with biological material should be strictly complied. The use of biobanking will increase the validity of data obtained in clinical trials in endocrinology. There are successful examples of Russian and foreign studies using the capabilities of biobanks aimed at studying diabetes, polycystic ovary syndrome, adenomas and other endocrine disorders. The article discusses the prospects for partnership with biobanks in the framework of endocrinology research. The purpose of this review is to analyze the literature to systematize knowledge for application of biobanking in biomedical research in the field of endocrinology.

The development of biomedical research based on predictive, preventive and personalized medicine has served as a challenge to the formation and rapid development of a novel interdisciplinary scientific area  — biobanking, the main goal of which is the long-term proper storage of biological samples and related data for use in scientific and clinical research. Qualified personnel, along with the creation and development of biobank infrastructure, provide high-quality results required for biomedicine. Education and training must reflect the changing scope of knowledge and adapt to biobanking challenges. In this regard, there is an increasing need to develop and implement educational programs for staff working in and managing biobanks, as well as researchers, doctors and students who are not familiar with this area, but plan research using bioresources. The aim of this review is to present an analysis of the main biobanking directions and training programs in the world and in Russia in order to assess the existing problems and needs.

Biosample preservation for future research is a fundamental component of translational medicine. At the same time, the value of stored biosamples is largely determined by the presence of related clinical data and other information. Electronic medical records are a unique source of a large amount of information received over a long period of time. In this regard, genetic and other types of data obtained from the biosample analysis can be associated with phenotypic and other types of information stored in electronic medical records, which pushes the boundaries in large-scale genetic research and improves healthcare. The aim of this review was to analyze the literature on the potential of combining electronic medical records and biobank databases in research and clinical practice.

The introduction of pharmacogenetic tests among the Russian population faces a fundamental limitation  — pronounced genetic differences between populations. The genetic geography of pharmacogenetic markers of deoxyribonucleic acid (DNA) helps to remove these limitations.

Aim. To reveal the spatial variation of the gene pools of the indigenous European Russian population in terms of DNA markers that are significant for the pharmacotherapy of cardiovascular diseases (CVDs) using the population biobank collections.

Material and methods. A total of 3170 samples from 61 populations of the Biobank of Northern Eurasia, which represents the gene pools of the indigenous Eastern Europe population, were studied using two pharmacogenetic DNA marker arrays as follows: 60 most significant markers and 24 markers associated with CVDs. Using the multivariate statistics and genetic geography, a comparison of gene pool variation was made.

Results. A cartographic atlas has been created that includes maps of the distribution among the Eastern Europe population of 24 pharmacogenetic CVD markers. These cartographic models allow various specialists to analyze patterns in the distribution of pharmacogenetic markers. General patterns are supplemented by regional studies in  the  North Caucasus, the Cisurals and the Russian Plain, which identify population groups with similar pharmacogenetic status. For each region, a comparison of gene pool variation for two arrays of above-mentioned DNA markers was made.

Conclusion. The created atlas is the basis for the development of pharmacogenetic studies conducted by genetic geography methods using a single panel of markers and representative samples provided by population biobanks. The reliability of the results is ensured by a detailed genealogical and population annotation of each biobank sample and representative samples from the populations.

The methodological rationale contains a description of epidemiological research methods, provides an analysis of the key concepts of epidemiology (population, sample, risk factor (RF)), in the context of  prevention priorities, as well as describes each of the main RFs for noncommunicable diseases (NCDs), including cardiovascular diseases. Emphasis is placed on behavioral and mediated biological RFs, such as smoking and alcohol consumption, poor nutrition (low consumption of vegetables and fruits), physical inactivity, high blood pressure, dyslipidemia and obesity, hyperglycemia and diabetes. The methodological rationale was created with the aim of popularizing epidemiological studies, expanding the scope of its use by clinicians, primary care physicians, specialists from medical prevention centers, providers of preventive measures, as well as decision makers in  the healthcare system. The sphere of the implementation of epidemiological data covers both the planning of preventive programs for the modification of risk factors in the population, and monitoring the effectiveness of preventive measures. These materials will also be useful in the development of a population, regional and municipal strategy for the prevention of NCDs and related RFs in Russia.