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The legal norms regulating the collection, storage and processing of human genetic information are aimed at ensuring the proper conduct of genetic research procedures and protecting the participants’ rights. It is particularly important to highlight that national legislation, taking into account international practice, should provide specific methods for collecting biological material, information storage periods and features of its processing. Purpose: to identify the legal characteristics of the collection, storage and processing of genetic information, including legal issues and criteria for modernizing the legislation governing genetic information research. Methods: empirical methods of comparison, description and interpretation, formal-legal, interpreting legal norms. Results: the article considers legal aspects and characteristics of regulating the process and conditions of collection, storage and processing of genetic information; it reveals some problems encountered in genetic research, regarding the storage time of materials and confidentiality in the processing of third-party information. The authors outline ways of improvement to address them.

Purpose of the study. Is to describe the experience of creating a collection of biological images of tumor tissues and biomaterials, which are control samples, for scientific research in morphology and molecular oncology.Materials and methods. We studied the molecular markers of cell cycle regulation, apoptosis, oncogenesis and angiogenesis, the expression of proteins that regulate inflammation and tumor infiltrate cells in biocollections of verified tumors of common localizations: e. g. thyroid cancer, colorectal cancer, breast cancer, prostate adenocarcinoma, endometrioid adenocarcinoma. Also, tissue fragments with normal structure or non-tumor pathology (autoimmune thyroiditis, adenomatous and thyrotoxic goiter, benign formations of the colon, fibrocystic disease of the mammary glands, benign prostatic hyperplasia, endometrial hyperplasia) were used as control samples or comparison groups. The total number of tissue samples is n = 7000.Results. It is reasonable to gather the collection in a pathomorphological laboratory according to the profile of the medical institutions, which has a sufficient volume of incoming target material and specialized morphologists to verify tumors of a given localization. It is necessary to consider the regional and ethnic specifics of the population, which determines the sampling and mutational load. The laboratory must initiate an addition to the informed consent of patients about the possibility of conducting morphological and molecular genetic studies for scientific purposes and publishing their results in a depersonalized form for the development of new elaborations, when signing the contracts with legal entities and individuals and when serving patients within an institution. When working with biocollections, it has to consider having registers of tissue biomaterials of target disorder groups of main localizations with downloading by year from an accessible information system, consider external factors affecting the database (changes in clinical recommendations and classifications, the population of patients served, pandemics and other significant events). The standard of the preanalytical stage, data collection, development of protocols for analytical molecular genetic studies and their evaluation, the utilization of the capabilities of working with reagents for scientific tasks and modeling experiments on laboratory animals are crucial.Conclusion. The formed biocollection made it possible to carry out a number of initiative and funded domestic and international scientific projects at the request of clinicians and fundamental researchers, as well as to improve the quality standards of morphological and molecular genetic oncology diagnostics. Biobanking makes the pathological archive more accessible for review and use, significantly expanding its scientific and practical potential. Scientific and medical research do not conflict and can be used within the same laboratory.

Aim. To analyze the metabolomic profile of patients with coronavirus disease 2019 (COVID-19) using mass spectrometry methods and taking into account clinical and laboratory history. Studying the relationship between the severity of COVID-19 symptoms and the concentration of primary metabolites, primarily amino acids.Material and methods. The retrospective study included serum samples from a total of 935 people (445 men and 490 women) with COVID-19 from the collection of the biobank of the City Hospital № 40. A metabolomic profile was studied in all samples using chromatography-mass spectrometry. The R language was used for statistical data processing.Results. Based on the analysis, a difference in the metabolic profile of patients with COVID-19 was identified depending on the disease severity — for 52 of the 84 detected compounds, differences were observed with a significance of p

Bioresource collection of the N. N. Blokhin National Medical Research Center of Oncology is a unique structured biobank that combines different types of primary and subsidiary samples and ensures its comprehensive characterization, including both generally accepted indicators and specific types of research. Samples of paraffin blocks, frozen material, blood and its derivatives are deposited in the clinical department of the center. The research institute of the center has collected commercial and unique human cell lines and transplantable strains obtained from clinical material, as well as cells from laboratory animals, mainly of mouse origin. The provided cell lines undergo multi- stage quality control, including confirmation of authenticity, assessment of viability and determination of optimal cultivation conditions, analysis of interspecific and intraspecific contamination, study of tumorigenicity and reproducibility in athymic Balb/ c-nude mice, etc. In addition, the Bioresource Collection has hybridoma clones that produce antibodies to a wide range of targets. The Center provides the opportunity to conduct preclinical research using samples from the Bioresource Collection to obtain scientific and regulatory data on the antiproliferative activity of new agents or methods for cancer treatment.

One technology that helps overcome the problem of low research reproducibility is biobanking, which involves maintaining strict quality standards at all stages. In addition to data on the biosample (detailed documentation on sampling, transportation, preparation and subsequent storage), one of the key points is the availability of information about the donor (patient). The aim of this article was to analyze creating clinical abstract of biospecimens, combining data from various biobanks and assessing the possibilities of electronic medical records and other modern technologies for this. The search for publications was carried out in the PUBMED, eLIBRARY.RU, RSCI databases. One approach to creating a clinical description is the targeted collection of information by a specially trained employee. Primary information is most often taken from the individual records of the study participant, which are developed and approved when planning work. An alternative method is the use of electronic medical records and other documents that collect information during the assessment and treatment of patients. There are also mixed types of clinical data collection, a prime example of which is the UK Biobank. Completeness, structure, and standardization are essential characteristics of clinical description associated with biospecimens. Various standards are currently being developed to unify clinical description, making biobanks and collections more available to external researchers and organizations, which is necessary for collaboration and more efficient use of stored biospecimens. Harmonization of clinical description methodology between different biobanks open up broad boundaries for large- scale research within personalized and translational medicine.

Aim. To validate and evaluate the accuracy of 14 genetic risk scores (GRSs) for type 2 diabetes (T2D), created earlier in other countries, using a Russian population sample from the biobank of the National Medical Research Center for Therapy and Preventive Medicine.Material and methods. For genetic analysis, next generation sequencing data was used on a sample from the Russian population (n=1165) based on the biobank collection. The study included 14 GRSs associated with T2D.Results. The study demonstrated that the predictive power of 12 out of 14 GRSs for T2D was replicated in the Russian population. As quality metrics, we used the area under the ROC curve, which for models including only GRS varied from 54,49 to 59,46%, and for models including GRS, sex and age — from 77,56 to 78,75%.Conclusion. For the first time in Russia, a study of 14 T2D GRSs developed on other populations was conducted. Twelve GRSs have been validated and can be used in the future to improve risk prediction and prevention of T2D in Russia.

In connection with the development of genetic and other types of research in translational medicine, collections containing a significant number of biospecimens and large data sets are required. Since in-depth examination of patients is most often carried out during hospitalization, the creation of collections based on electronic medical records (EMR) data is promising. In this regard, the project "Total biobanking in the hospital of the National Medical Research Center for Therapy and Preventive Medicine" was initiated, aimed at total biobanking of blood and related products from patients in inpatient departments and the creation of a unified system that combines information on biosamples, clinical and other types of data.Aim. To describe the collection of biospecimens collected within the project "Total biobanking in the hospital of the National Medical Research Center for Therapy and Preventive Medicine" for August 2023, and to analyze the process of biospecimen description.Material and methods. Recruitment of patients is carried out on the basis of inpatient departments of the National Medical Research Center for Therapy and Preventive Medicine, only if the patient signs informed consent. After blood is taken, the biomaterial enters the biobank, where sample preparation and storage is carried out, as well as data about each biosample is entered into a special FreezerPRO system. At the same time, clinical data about the patient is collected using EMR, which are combined in the Medialog medical information system.Results. A special software for data exchange between the medical information system and the biobank has been developed, which combines information about patients entering the Medialog medical information system and the FreezerPro biospecimen management system, which contains detailed information about biospecimens. As of August 25, 2023, biomaterial from 3996 patients was collected, which was accompanied by a detailed clinical summary. In particular, data is available on diagnoses (for 100% of patients), laboratory test data (100%), paraclinical data, in particular, electrocardiography (100%), echocardiography (76,8%), 24-hour Holter monitoring (59,8%), esophagogastroduodenoscopy (27,3%), etc. The most common diseases were hypertension (76,0%), atherosclerosis (69,9%), coronary artery disease (52,9%), arrhythmias (50,6%), diabetes (19,2%). In addition, 25,0% of patients had prior stenting.Conclusion. Total biobanking within the hospital of a multidisciplinary research medical center allows for the rapid and high-quality collection of biomaterial and related data. A collection of biospecimens with comprehensive and detailed clinical annotations has been collected. A primary analysis of the collection was carried, which showed that it can be used for a wide range of studies.

Aim. To develop an algorithm and manage total biobanking of samples of whole blood, serum and plasma of patients in the hospital of the National Medical Research Center for Therapy and Preventive Medicine in order to create a detailed biosample collection through the integration of electronic medical records and a biobank database.Material and methods. The study includes all patients admitted to the hospital of the National Medical Research Center for Therapy and Preventive Medicine in various departments who signed informed consent for biobanking. Clinical information is collected as part of patient examination and stored in electronic medical records in the Medialog medical information system. Biobanking of blood and related products is carried out in accordance with standard operating procedures. From each patient, 12 aliquots of serum and blood plasma are stored, as well as 1 tube of whole blood with ethylenediaminetetraacetic acid potassium salt. Information about biospecimens, patient identification numbers and storage location coordinates are contained in the biobank database.Results. An algorithm for total biobanking of biomaterial and data from inpatients has been developed and put into practice. This collection is associated with large biomedical data stored in a medical information system, laboratory information system and biobank. The combined databases make it possible to search for samples in the collection according to specified criteria.Conclusion. The collection developed can be used for a wide range of studies by forming patient samples according to the necessary criteria. The developed algorithm for total biobanking in a hospital can be used in various medical centers equipped with biobanks.

Currently, monitoring infectious morbidity, control and forecasting the epidemic process is a topical health problem.Aim. To analyze the capabilities of the biobank for serological monitoring of infectious diseases using the Epstein- Barr virus (EBV), which is associated with infectious mononucleosis, as well as somatic pathology, including cancer.Material and methods. Using the quantitative enzyme- linked immunosorbent assay for specific antibodies to various EBV proteins, we studied blood serum samples from healthy individuals (2010, 2016, 2019, 2020, 2021 and 2022) from the collection of the N. F. Gamaleya National Center of Epidemiology and Microbiology.Results. For the first time, the intensity of EBV epidemic process among apparently healthy adult residents of the capital was assessed using samples of biological material and a biobank information database. At the time of examination, 0,8% of individuals were not infected with EBV, and 9,4% suffered reactivation of a chronic infection. There were no significant changes in detection rate of markers over the years.Conclusion. Certified collections of blood sera can be effectively used to study population immunity, the prevalence of individual infections, population protection nationwide, etc.

Aim. Creation of a sample collection of whole blood, leukocyte suspension, genomic deoxyribonucleic acid from patients with myocardial infarction for fundamental and applied research in medicine.Materials and methods. The collection, transportation and processing of biomaterial samples in the biobank of the Medical Institute of Surgut State University were carried out according to standard methods using recommendations, standard operating procedures and national guidelines for biobanking.Results. As of September 1, 2023, the collection has collected 744 aliquots of whole blood and leukocyte suspension and isolated 108 samples of genomic deoxyribonucleic acid from 108 donors after myocardial infarction. Aliquots of samples from the biobank collection are actively used for a number of molecular genetic studies (genotyping, massively parallel sequencing).Conclusion. This biosample collection on the basis of Surgut State University provides current and future research projects in cardiology with high-quality biomaterial.

Biobanks are the platform for innovative biomedical research in the field of translational and personalized medicine. The important aspect for conducting large-scale research in the field of genomics, transcriptomics, proteomics is the availability of a sample information of the documented high-resolution samples. The biobanks solve the problem of forming groups of patients with different nosology within the population of interest and provide clinical and laboratory information on each sample. The aim of this article is to describe the Biobank processes of the National Medical Research Centre for Oncology within the framework of existing projects and build up collections. The review discusses the main stages of the systematized biobank process, describes the methods of sample preparation of different types of biological material, and also provides statistics of the build up collections. To this date, the predominant part of the depository consists of tissue samples of patients diagnosed with colorectal cancer 24% and stomach cancer 23% of the total number of tissue samples, while the number of tissue samples of pancreatic cancer is 10%, and esophageal cancer and breast cancer 22%. In addition to tissue samples, the biobank of the National Medical Research Centre for Oncology stores 24 cell lines of a human origin and the collection of 200 microbiota samples: 100 are from patients diagnosed with lung cancer and 100 from conditional healthy donors. Currently, the studies have been performed on biomaterial from the biobank build up collections to search for prognostic biomarkers and potential targets for targeted therapy by using high-throughput sequencing in patients diagnosed with pancreatic cancer and brain cancer. Thus, the collections play an important role for research in the field of personalized medicine, providing early diagnosis and effective treatment for each patient.

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.

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.

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.

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.

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.

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 optimize the technique for the isolation and storage of ribonucleic acid (RNA) from whole blood and leukocyte fraction.Materials and methods. Comparison of isolation quality was carried out for RNA samples obtained from 228 leukocyte samples and 198 whole blood samples. Isolation was performed from fresh and frozen samples using ExtractRNA™ reagent and a MagNA Pure Compact automated system. Various methods of removing erythrocytes (centrifugation and treatment with hemolytic agents from two manufacturers) were tested, as well as freezing with and without preservatives for subsequent RNA isolation.Results. Twenty-one combinations of conditions were tested. The highest quality RNA was isolated by manual extraction using the ExtractRNA™ reagent from a fresh leukocyte fraction, purified by the Amplisens hemolytic agent (successful extraction — 94%, median RIN=8,4); frozen in IntactRNA™, purified by leukocyte fraction centrifugation (successful extraction — 100%, median RIN=8); frozen in ExtractRNA™, purified by leukocyte fraction centrifugation (successful extraction — 100%, median RIN=9,3).Conclusion. RNA can be isolated from frozen blood fractions, which is not inferior in quality to that isolated from fresh samples. Thus, it is not necessary to isolate RNA immediately after the receipt of biological material.

Biobanking is one of the most important elements of the modern infrastructure for biomedical research. Organization of a biobank on the basis of the N. P. Bochkov Medical Genetics Research Center provides a centralized infrastructure for preparing biomaterial for research. Biobank has the format of a research equipment sharing center and works with two types of unique biomaterials from patients with genetic diseases: blood/blood components and vital cells of various tissue origin. The storage facility of the Biobank is equipped with low-temperature (-80° C) and cryostorage (-196° C) systems. Identification and search of samples is carried out using a bar-coding system and is implemented through the information interface of the biobank, which is integrated into the general database of patients at the Medical Genetics Research Center. Information on biomaterial samples is presented in periodically updated catalogs on the page of equipment sharing center “Biobank”. Biobank collection is available to internal and external users.

Conducting fundamental and clinical research in the field of tuberculosis is an important step towards reducing related morbidity and mortality, but access to a sufficient number of high-quality samples required for research is an unsolved problem in Russia. This review is devoted to biobanking as a key component of modern research in personalized medicine, as well as to the status and prospects for developing this area in phthisiology and infectious diseases combined with tuberculosis.

Aim. To create a collection of samples of blood components of patients with multiple myeloma for potential fundamental and applied biomedical research.Material and methods. The material was collected according to the developed algorithm, including the collection of clinical information, biological material, sample preparation, quality control and storage in the biobank of the National Medical Research Center of Oncology.Results. As of August 2021, the cryostorage of the National Medical Research Center of Oncology biobank contains a collection of 175 samples of blood serum, plasma and mononuclear cell fraction of patients with multiple myeloma. Samples were obtained from 32 patients of both sexes, the mean age of which was 59,5±1,65 years. To create an electronic catalog, personal, clinical and laboratory data about patients were collected, after which each sample was assigned its own unique identification number. Written informed consent was obtained from all patients for the storage of their biomaterial in a biobank with possible subsequent use for scientific purposes. Freezing of the obtained samples was carried out in accordance with low-temperature storage protocol. The electronic catalog contains a wide range of systematized clinical and laboratory information on samples.Conclusion. The collection of multiple myeloma samples is a unique resource for potential research on its pathophysiology, the development of diagnostic biomarkers, and the search for targeted agents.

The growing prevalence of metabolic disorders creates an increasing demand for novel approaches to their prevention and therapy. Novel genetic diagnostic technologies are developed every year, which makes it possible to identify people who are at the highest genetic risk of diabetes, non-alcoholic fatty liver disease, and metabolic syndrome. Early intervention strategies can be used to prevent metabolic disorders in this group of people. Genetic risk scores (GRSs) are a powerful tool to identify people with a high genetic risk. Millions of genetic variants are analyzed in genome-wide association studies in order to combine them into GRSs. It has become possible to store and process such huge amounts of data with the help of biobanks, where biological samples are stored according to international standards. Genetic studies include more and more people every year that increases the predictive power of GRSs. It has already been demonstrated that the use of GRSs makes future preventive measures more effective. In the near future, GRSs are likely to become part of clinical guidelines so that they can be widely used to identify people at high risk for metabolic syndrome and its components.

With aging, tissue homeostasis and their effective recovery after damage is violated. It has been shown that this may be due to the excessive accumulation of senescent (SC) cells in various tissues, which leads to the activation of chronic sterile inflammation, tissue dysfunction and, as a result, to the development of age-related diseases. To assess the contribution of SC cells to human body aging and pathogenesis of such diseases, relevant biomarkers are studied. For successful translation into clinical practice of approaches aimed at regulating the SC cell content in various tissues, it is necessary to study the relationship between the established clinical biomarkers of aging and age-related diseases, systemic aging parameters, and SC biomarkers at the tissue and cellular levels.Aim. To develop and describe action algorithms for creating a biobank of samples obtained from patients aged >65 years in order to study biomarkers of SC cell accumulation.Material and methods. To collect samples, an interaction system was built between several research, clinical and infrastructure departments of a multidisciplinary medical center. At the stage of preanalytical training, regulatory legal acts were developed, including informed consent for patients, as well as protocols for each stage of the study.Results. A roadmap was formed with action algorithms for all participants in the study, as well as with a convenient and accessible system of annotations and storage of biological samples. To date, the collection includes biological samples of 7 different types (peripheral blood serum, formalin-fixed tissue samples and formalin fixed paraffin embedded tissue specimens, samples of different cells isolated from peripheral blood, skin and adipose tissue, samples of deoxyribonucleic and ribonucleic acids, cell secretome conditioned media) obtained from 82 patients. We accumulated relevant anamnestic, clinical and laboratory data, as well as the results of experimental studies to assess the SC cell biomarkers. Using the collection, the relationship between clinical, tissue and cellular biomarkers of SC cell accumulation was studied.Conclusion. The creation of a collection of biological samples at the molecular, cellular, tissue and organism levels from one patient provides great opportunities for research in the field of personalized medicine and the study of age-related disease pathogenesis.

Aim. To analyze the structure of clinical data, as well as the principles of collecting and storing related data of the biobank of the National Medical Research Center for Therapy and Preventive Medicine (hereinafter Biobank).Material and methods. The analysis was carried out using the documentation available in the Biobank, as well as the databases used in its work. The paper presents clinical data on biosamples available in the Biobank as of August 18, 2021.Results. At the time of analysis, the Biobank had 373547 samples collected from 54192 patients within 37 research projects. The article presents the analysis of data representation and quantitative assessment of the presence/absence of common diagnoses in clinical projects. Approaches to documenting clinical information associated with biological samples stored in the Biobank were assessed. The methods and tools used for standardization and automation of processes used in the Biobank were substantiated.Conclusion. The Biobank of the National Medical Research Center for Therapy and Preventive Medicine is the largest research biobank in Russia, which meets all modern international requirements and is one of the key structures that improve the research quality and intensify their conduct both within the one center and in cooperation with other biobanks and scientific institutions. The collection and systematic storage of clinical abstracts of biological samples is an integral and most important part of the Biobank’s work.

Osteoporosis is a chronic systemic disease of the skeleton, characterized by a decrease in bone mass and an impairment of bone microarchitecture, which can lead to a decrease in bone strength and an increase in the risk of minor trauma fractures. Osteoporosis is diagnosed on the basis of bone mineral density (BMD). BMD is characterized by high heritability that ranges according to various sources from 50 to 85%. As in the case of other complex traits, the most common approach to searching for genetic variants that affect BMD is a genome-wide association study. The lower effect size or frequency of a variant is, the larger the sample size is required to achieve statistically significant data on associations. Therefore, the studies involving hundreds of thousands of participants based on biobank data can identify the largest number of variants associated with BMD. In addition, biobank data are used in the development of genetic risk scores for osteoporosis that can be used both in combination with existing prognosis algorithms and independently of them. The aim of this review was to present the most significant studies of osteoporosis genetics, including those based on biobank data and genome-wide association studies, as well as studies on the genetic risk scores and the contribution of rare variants.

The success and quality of large-scale epidemiological studies depends entirely on biomaterial quality. Therefore, when arranging the third Epidemiology of Cardiovascular Diseases and their Risk Factors in Regions of Russian Federation (ESSE-RF-3) study, increased attention was paid to specifics of collection, processing and further transportation of biological samples and related clinical and anthropometric data of participants from regional collection centers to Biobank.Aim. To develop a methodology for collection of high-quality biomaterials within the large-scale epidemiological study, involving the sampling, processing, freezing of blood and its derivatives (serum, plasma) in the regions, followed by transportation and storage of obtained biomaterial in the Biobank of National Medical Research Center for Therapy and Preventive Medicine (Moscow).Material and methods. To conduct the ESSE-RF-3 study, a design was developed, according to which the collection of venous blood samples in a total volume of 29,5 ml from each participant is planned in all participating regions in order to obtain and store samples of whole blood, serum and two types of plasma.Results. On the basis of international biobanking standards, ethical norms, experience from ESSE-RF and ESSE-RF-2, and literature data, a protocol for biobanking of blood and its derivatives was developed. The type and number of serum and plasma aliquots obtained, the required standard technical means and consumables, as well as logistic biomaterial requirements were determined. Training programs for regional participants were developed. By the beginning of August 2021, 180 thousand samples of whole blood, serum and plasma from more than 23 thousand participants from 28 Russian regions were collected, processed and stored.Conclusion. The presented work made it possible to assess and confirm the compliance of developed biobanking protocol with quality requirements. However, due to the coronavirus disease 2019 pandemic, by August 2021, the Biobank did not reach the maximum effectiveness predicted for the ESSE-RF-3 project.

Introduction. Biobank is a large-scale biomedical database and an important research resource for conducting scientific, translational, clinical research aimed at developing new treatment methods in modern medicine. Materials and methods. Biological materials (tumour, venous blood) from patients with glial tumours were selected for the study. Biomaterials were processed and cryopreserved in a biobank. Histological, immunohistochemical and molecular genetic studies were performed to establish the diagnosis. All information about the biosamples was recorded in an electronic biobank database. Results: For three years of research (from 2018 to 2021), 777 aliquots from 269 patients were collected in the biobank of the National Centre for Neurosurgery. These are patients mainly with glial tumor lesions of the brain of the III-IV degree of malignancy. All clinical and pathomorphological results of patients are stored in an electronic information system. Conclusion: This biobank will allow us to search for new methods of treatment, improve the quality and increase the life expectancy of neurosurgical patients in the Republic of Kazakhstan. To attract investment from both domestic and foreign investors in the development of scientific research, which together with the above will contribute to the positive development of the country’s economy. The article was prepared within the state order for scientific programme realization under the budget programme 217 «Development of science», subprogram 101 «Programmed target-oriented financing of scientific and/or scientific-technical activity subjects at the expense of the republican budget», subject: BR10965225 «Development of molecular-cytogenetic research programme and creation of biobank of central nervous system tumours». [ABSTRACT FROM AUTHOR]

To carry out research projects, clinical trials and other studies in the field of personalized medicine, it is necessary to have collections of high-quality biological samples of various types. With the development of biomedical technologies, the need for large collections of biological samples will grow every year, which necessitates the creation of various biobanks for standardized collection, storage and distribution of such samples. One of the goals of the National Association of Biobanks and Biobanking Specialists is the development of a network of Russian biobanks interacting with each other at various levels, as well as the development and implementation of organizational and legal tools for its regulation. It is required not only to standardize the access and exchange of biological samples and data, but also to create a unified terminology that will be used by biobanks throughout Russia. The main aim is to create an accurate, professional and legally correct tool containing information accessible and understandable to a wide range of researchers.

The advances of biomedicine include the new technologies, diagnosis and treatment techniques, as well as the practical use of new types of biological targets, in particular, nucleic acids. Genomic deoxyribonucleic acid (DNA), extracellular DNA (exDNA) and microbiome DNA obtained from different types of samples (tissues, blood and its derivatives, feces, etc.) are used as objects of genetic research. The use of new technologies for DNA analysis required the development of standardized methods for processing biological samples in order to obtain high-quality DNA samples. The research uses various methods for collecting, preparing samples and storing various DNA-containing biomaterials and isolated DNA, as well as methods for assessing the quality of samples and biobank standards. It is obvious that the use of uniform standards will allow large-scale genetic research on the basis of biobanks and research laboratories. Specialists from professional organizations such as International Society for Biological and Environmental Repositories (ISBER), Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC), European, Middle Eastern & African Society for Biopreservationa and Biobanking (ESBB) and the Russian National Association of Biobanks and Biobanking Professionals.

Aim. To create a collection of samples from women at different stages of pregnancy to search for early biomarkers of preterm birth.Material and methods. In order to standardize the sample collection, standard operation procedures have been developed with a step-by-step protocol for each research member at the clinical (collection of medical data and biological material) and laboratory (transportation, sample preparation, storage, quality control) stages.Results. As of October 1, 2020, the collection includes peripheral blood samples from 182 women. Whole blood, serum, plasma, buffy coat and urine were collected during pregnancy, and placenta and umbilical cord blood samples — during labor. Clinical and medical history data was obtained about each pregnant woman, which includes data on the woman’s health status, the course and outcome of pregnancy. An electronic catalog has been created with information on samples (data on clinical characteristics and the number of aliquots of each sample type). The quality control (assessment of DNA and microRNA) was carried out, which showed the compliance of the obtained samples with the quality criteria and the preservation of initial characteristics during long-term storage. On the basis of collection, a study has begun to assess the level of microRNA expression in various types of biomaterial, in order to search for early biomarkers of premature birth.Conclusion. The creation of a collection of samples from pregnant women is a significant groundwork for future fundamental and applied research in various fields of biomedicine. This collection may provide an in-depth study of the pathogenesis of various pregnancy complications and the development of new methods for their diagnosis and treatment.-

Aim. To study the effect of the shelf life of frozen whole blood samples in a biobank on the amount of released deoxyribonucleic acid (DNA).Material and methods. The study included whole blood samples placed in tubes with the anticoagulant EDTA (ethylenediaminetetraacetic acid at a concentration of 1,8 mg/ml) from participants in the epidemiological study ESSE-RF-1 and ESSE-RF-2 and cohort studies conducted at the National Medical Research Center for Therapy and Preventive Medicine. The samples were stored in the biobank of the National Medical Research Center for Therapy and Preventive Medicine at temperature from -22О C to -32О C. The shelf life from blood collection to DNA extraction ranged from several weeks to 11 years. DNA was extracted using QIAamp DNA Blood Mini Kit (250) and 96 Blood Kit (Qiagen, Germany). Statistical analysis was performed using the R 3.6.1 software. To analyze the association of blood storage time with the logarithm of DNA concentration, a linear regression was used.Results. The analysis included data on the DNA concentration of 5405 samples. Multivariate regression showed that the blood shelf life was significantly associated with a decrease in concentration by 3,92% (3,16-4,68) for each year of storage (p

Aim. Using a collection of samples from the biobank ofCityHospital № 40 ofSt. Petersburg, to study the cytokine profile in patients with coronavirus disease 2019 (COVID-19) and sepsis, in comparison with patients with abdominal inflammation and septicemia.Material and methods. The study included serum samples from 181 patients with sepsis and COVID-19 (127 patients with a diagnosis confirmed by polymerase chain reaction (PCR); 54 patients with a negative PCR test, but with a characteristic computed tomographic lung performance) and 47 patients with abdominal sepsis. The content of cytokines was determined using a multiplex immunofluorescence analysis based on the Luminex xMAP technology using the HCYTOMAG60K panel — a soluble CD40 ligand (sCD40L), interleukin-1α (IL-1α), interleukin-1β (IL-1β), interleukin 6 (IL-6), interleukin 8 (IL-8), monocyte chemoattractant protein 1 (MCP-1), tumor necrosis factor alpha (TNFα), vascular endothelial growth factor (VEGF). Other laboratory parameters (C-reactive protein (CRP), ferritin, procalcitonin) were taken from patient records. Normality of distribution was assessed by the Shapiro-Wilk test. To compare groups, the Mann-Whitney test for independent samples, Wilcoxon test for dependent samples, and the Kruskal-Wallis test with Bonferroni correction for multiple comparisons were used.Results. In patients with sepsis and COVID-19 infection, no differences in the concentrations of cytokines, ferritin and CRP were found between the groups with detected and not detected virus by PCR test. Based on this, this group was considered homogeneous when studying the cytokine profile. It was shown that in patients with sepsis and COVID-19, significantly higher levels of sCD40L (p

Review focuses on estimation of population immunity and effectiveness of vaccination against socially significant influenza infection. Long-term observations of the population immunity, including post-vaccine seroprevalence to influenza are an important component of surveillance. The possibility of use of systems of biological banks (biobanks) in these investigations is of great interest. The data on the principles of biobanks design in the world, the scope of their application, the present state of the industry are described. The information about collections of infectious diseases agents is presented. Suggestions to build a network of biobanks in the Russian Federation and its implementation in the system of epidemiological influenza surveillance are formed. The biobanks filling by samples, principles of selection of donors biological specimens, methods of laboratory research are discussed.

The first biobank in Russia was created in 1998 to investigate post-Chernobyl thyroid tumors. The number of biobanks in the world is growing. Infrastructure and collaboration are improving. Ethical, legal and methodological guidelines for biobanking have been developed and are regularly reviewed. Biobanking objects are now not only biological samples of patients but also their dynamic biomedical characteristics. Comparison of genetics, proteome and tumour metabolism and in vivo radiological visualization is necessary to improve personalized diagnostics, treatment and its effectiveness. The article focuses on international evidence-based experience of sample preparation and cryopreservation of biological samples, information logistics, and integration solutions in biobanking. Guiding principles and the model of a modern biobank, integrating up-to-date technologies of digital personalized medicine and telemedicine in oncology and radiology are reported. The article may be of interest to a wide range of experts in biomedicine, especially oncologists, radiologists, pathologists, geneticists, and IT specialists.

Organ shortage remains to be a crucial issue in transplantation. However, it’s not the only challenge that modern transplantation is facing. There are critical issues to be solved, such as, choosing optimal patient-specific immunosuppressive regimen, preventing or coping effectively with graft rejection and improving graft and patient survival rates. There are still a number of ongoing studies on ischemia-reperfusion injury mechanisms. It is also unknown what the true limitations of organ viability are and what mechanisms actually regulate it. The upcoming era of personalized medicine dictates the necessity for individualized approach to these issues. The creation of transplant biobanks followed by different studies on their base may be the key option to resolve problems of modern transplantation. Biobanks are an essential basis of personalized medicine, which allows largescale population studies, discovery of new biomarkers and therapy targets as well as new drugs development. The importance of this relatively new fi eld has increased over last decades making its way from small collections of samples to large national and international biorepositories. There are biobanks of different types and purposes. In this article a systematic review is given covering historical reference, term definition, and classifi cation variants. Furthermore, the current state of the industry is highlighted along with current issues and perspectives with respect to transplantation.

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.

Biobanking is crucial for the development of life sciences in general and biomedical science in particular. A systematic study of stored biomaterials enables the discovery of new biomarkers for various physiological and pathophysiological states, identification of the drug targets, and validation of these findings in human population studies. During the last decades, the importance of biobanking has increased in parallel with the growth in their size from relatively small collections to very large national and international biorepositories. Here, we have systematically reviewed modern approaches to biobanking, a variety of biobank definitions and types, and the current states of biobanking art in Russia and in the world and have discussed the obstacles to the global development of biobanking, along with possible solutions.