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.

Aim. To identify new markers using omics technologies for use as predictors of fetal growth and developmental abnormalities in gesta­tio­nal diabetes (GD).

Material and methods. The long-term goal of this study is to create a unique biological sample collection that can be used to assess the risk of diabetic fetopathy (DF) and other adverse perinatal outcomes by identifying early preclinical markers. To achieve this goal, the following studies were planned for the first stage: the formation of a reference collection of biomaterial from women with a known perinatal outcome and its subsequent comprehensive analysis to identify key markers. Conducting complex experiments using genetic, immunological, and mass spectrometric approaches allows for a comprehensive assessment of molecular GD pathogenesis and the identification of complementary biomarkers. For this study, a collection of plasma samples from pregnant women in the first trimester, women in labor, amniotic fluid, and umbilical cord plasma was compiled. The resulting biomaterial samples were frozen and stored at a temperature not exceeding -80 оC. A sample of 100 women aged 18-45 years, at 34 weeks 1 day to 41 weeks 6 days of gestation, from both groups with and without GD, was included in the current study. Enzyme-­linked immunosorbent assay (ELISA) was performed on samples for a number of regulatory proteins and embryotropic antibodies, molecular genetic analysis of hemostasis gene polymorphisms, and mass spectrometric analysis of amino acids.

Results. A comparative analysis revealed that pregnant women with GD were more likely to have the FGB 455 G/A fibrinogen gene poly­mor­phism (p=0,008), and their autoimmune antibody profile was altered, consistent with supraphysiological apoptosis and insulin resistance. In the absence of fetal macrosomia, maternal plasma levels of tissue plasminogen activator were lower (p=0,001). The main findings of mass spectrometry of amino acids in the blood of women with GD were lower concentrations of tryptophan (p=0,025) and γ-aminobutyric acid (p=0,023). In amniotic fluid and cord blood in GD, decreased concentrations of amino acids responsible for protein synthesis (lysine and methionine) and increased concentrations of amino acids associated with macrosomia were detected.

Conclusion. The study results confirm metabolic, immune, and hemo­rheo­logical disturbances in maternal GD, associated with abnormal ami­no acid composition in cord blood and amniotic fluid in neonates with macrosomia. The identified differences in the metabolome can be con­si­dered potential markers for identifying the risk of unfavorable peri­natal outcomes.

Aim. To demonstrate the development and potential applications of bio­medical resource collections of pediatric patient biomaterials, as well as the potential for their differentiated use for clinical and research pur­poses in a multidisciplinary hospital setting at a federal research center.

Material and methods. The study included biomaterial from pediatric pa­tients and their first-­degree relatives, banked between 2016 and 2025 as part of research projects at the Almazov National Medical Re­search Center in the field of clinical genetics and pediatrics. De­oxy­ri­bo­nucleic acid (DNA) isolated from whole blood samples and dried blood spots was used for genetic testing using modern molecular genetic dia­gnos­tic methods.

Results. The potential of using bioresource collections of pediatric pa­tient biomaterial was demonstrated using familial cases of rare mo­no­genic diseases, for which previously collected biomaterial from the biobank was used to establish a diagnosis and determine follow-up strategies for family members, identify risks to future offspring, and re­ceive advance data on the management of patients with spe­ci­fic he­re­ditary syndromes. Additionally, the ability to predict new phe­no­ty­pes associated with a known gene, and conversely, to uncover the rela­tion­ship of new genes with a known phenotype, was demonstrated using examp­les of familial diseases, where biobank biomaterial enabled seg­re­gation analysis. Using biomaterial from cohorts of patients with a specific pathology, the potential for developing novel diagnostic al­go­rithms and laboratory test systems, a differentiated approach to se­lec­ting a targeted genetic panel for diagnosis, and the identification of new clinical and genetic disease features was showed. A founder mu­ta­tion was showed to be identified in a pathology determined in a spe­cific ethnic group, with the potential to describe the onset time and geo­graphic distribution.

Conclusion. The creation of bioresource collections obtained from pediatric populations is a complex, yet extremely important, clini­cal­ly necessary, and promising scientific task. Its implementation faci­li­tates translational research aimed at improving diagnostic methods, under­stan­ding the pathogenesis and progression of childhood diseases, and the influence of environmental factors on their development. It also faci­litates the search for new genetic causes of hereditary pathologies and the description of new phenotypes associated with known genes. It also identifies predictors of disease severity and prognosis. In the long term, it facilitates the search for novel therapeutic approaches and under­stan­ding the disease pathogenesis in adults.

Aim. Using a bioresource collection, to study the expression of cyto­kines, chemokines, and growth factors in patients with myocardial in­farc­tion (MI) aged 80 years and older and to establish their rela­tionship with unfavorable outcomes.

Material and methods. This retrospective study included 59 patients aged 80 years and older with acute coronary syndrome (ACS). Cli­ni­cal and demographic data, laboratory parameters, and biomarker dynamics at hospital admission and after 7 days were analyzed. Thirty-day outcomes were assessed. Patients were divided into groups based on outcomes as follows: group 1 (n=11) — patients who died within 30 days after ACS; group 2 (n=48) — the remaining patients.

Results. Follow-up in the overall group revealed a significant decrease in serum levels of interleukin (IL)-6, IL-8, and granulocyte colony-­sti­mulating factor at day 7 after ACS, while eotaxin levels, conversely, in­creased. Associations between proinflammatory cytokines and clinical risk stratification scores were revealed. In the fatal group, higher levels of IL-10, IL-15, tumor necrosis factor-­alpha, monocyte chemotactic protein 1, granulocyte colony-­stimulating factor, macrophage colony-sti­mulating factor, and N-terminal pro-brain natriuretic peptide (NTproBNP) were noted at day 7 after ACS. The combination of NTproBNP >1000 pg/ml and IL-15 >25 pg/ml on day 7 has the highest prognostic value for predicting patient mortality within 30 days after ACS, with a sensitivity of 83,3% and a specificity of 90,6% (AUC=0,87).

Conclusion. Using a bioresource collection and multiplex technology, the expression of cytokines, chemokines, and growth factors was stu­died in patients over 80 years of age with myocardial infarction. A model for predicting unfavorable outcomes in patients with myocar­dial infarc­tion was developed.

Aim. To study the genogeography of SNP markers associated with severe coronavirus disease 2019 (COVID-19) and identify patterns of their distribution in indigenous populations of Russia and worldwide. The frequency of genetic polymorphisms associated with COVID-19 complications varies across ethnic groups.

Material and methods. Using collections from the Biobank of the National Medical Research Center for Therapy and Preventive Medicine and the Biobank of Northern Eurasia, we determined the allele and geno­type frequencies of the NFKBIA, TLR3, and TMPRSS2 genes asso­ciated with COVID-19 complications. The analysis included our own data (4207 samples from 186 populations of 97 ethnic groups from Rus­sia and neighboring countries) and published data (3070 samples from 227 populations worldwide). The data were analyzed using bio­informatics, statistical, and cartographic methods.

Results. A high frequency of the "risky" GG homozygote of the NFKBIA marker (rs696) was detected in Russian populations (0,55), with an in­creasing trend from west to east across the widest range as follows: from 0,08 among the Izhorians in the northwest to 0,92 among the Evens in the Far East. The Russian population is characterized by high fre­quencies of alternative homozygotes of the TLR3 (rs3775291) and TMPRSS2 (rs2070788) polymorphisms, which are not associated with the risk of COVID-19 complications. The indigenous populations of Nort­hern Eurasia possess the greatest genetic diversity of any region in the world. At the same time, they are harmoniously integrated into the gene pool of the Eurasian continent, and the Russian Far East is a tran­sition zone to the gene pool of the indigenous populations of North America.

Conclusion. A study of genogeographic variation makes it possible us to identify regions of Russia and the world for which the analyzed DNA markers pose the greatest risk for severe COVID-19.

Aim. To analyze the frequency and potential association with the severity and outcome of coronavirus disease (COVID-19) of MUC5B rs35705950, TERT rs2736100, TLR3 rs3775290, and TLR7 rs179008 polymorphisms.

Material and methods. The study included blood samples from 4783 patients diagnosed with COVID-19 from the biobank of City Hos­pi­tal № 40 (St. Petersburg). All patients signed informed consent to par­ticipate in the study. Genotyping was performed using real-time poly­me­rase chain reaction. Statistical analysis included Fisher's exact test and multiple regression.

Results. Polymorphism frequencies are comparable with the Genome Aggregation Database (gnomAD). Among all polymorphisms, only the AA genotype of the TLR7 gene showed a significant association with severe COVID-19. Two following potentially significant genotype interactions were also identified: TERT AA + TLR7 T in men and TERT CC + TLR3 CT in women.

Conclusion. The results highlight the value of local biobanks for stu­dying population-­based patterns of allele distribution and identifying genetic factors influencing the course of infectious diseases.

Aim. To study the effect of storage temperatures (-20 and -70 оC) and exposure duration (6 months and 6 years) on the preservation and stability of specific anti-hepatitis B virus HBs antigen IgG antibodies (anti-­HBs IgG) in serum samples stored in a biobank.

Material and methods. An experimental study was conducted on 180 serum samples. Anti-­HBs IgG levels were determined by enzyme-­linked immunosorbent assay (ELISA) using Vector-­Best test systems (Russia) in native samples and after storage according to two following scenarios: 1) storage at -20 and -70 оC for 6 months; 2) storage at -70 оC for 6 months and 6 years. Statistical analysis was performed using nonparametric methods (Wilcoxon test, median, interquartile range, Spearman correlation coefficient).

Results. The study using the first scenario found that storage at -20 оC for 6 months led to an almost 2-fold increase in the median anti-­HBs IgG level (from 35,5 (7,8-76,8) to 65,3 (26,0-105,0) IU/ml) and 9 false-­positive results. In the second scenario study, storage at -70 оC for 6 months was accompanied by a slight decrease in antibody levels (from 72,5 (27,9-132,0) to 49,3 (4,0-98,4) IU/ml) without false positive results. After 6 years of storage at -70 оC, a further decrease to 33,3 (6,15-88,4) IU/ml was noted, with 2 samples becoming false negative. A strong correlation was found between antibody levels in native samples and after storage (р=0,97-0,99; p<0,05).

Conclusion. Long-term (up to 6 years) storage of serum samples at -70 оC is reliable and does not critically distort the results of population serological studies of anti-­HBs IgG prevalence. Storage at -20 оC is only acceptable for short-term storage, as after just 6 months it leads to false-­positive results and an overestimation of the average antibody level, making it unsuitable for biobanking.

Aim. To create rat testicular cell collections characterized by pheno­types and functional activity to determine optimal conditions for their use in models for assessing the specific activity of spermatogenesis restoration drugs.

Material and methods. To isolate different cell types from rat tes­tes, sequential enzymatic treatment of testicular tissue was used. Immu­no­cytochemical analysis of the isolated cell cultures was performed for canonical and non-canonical markers. Testosterone secretion by Leydig cells was measured on days 2, 4, and 7 of culture using enzyme-­linked immunosorbent assay. The developed model for assessing the biological activity of drugs in Leydig cells was validated in accordance with the requirements of the Eurasian Economic Commission Decision dated July 17, 2018, № 113.

Results. The following cell cultures were isolated from rat testes and characterized: Leydig cells expressing specific CYP11A1 and LHR markers; resident mesenchymal stromal/stem cells expressing CD73, CD90, and PDGFRb markers; Sertoli cells expressing inhibin beta B and Sox9 markers; spermatogonial stem cells expressing GDNFR, c-kit, and alkaline phosphatase markers; and peritubular myoid cells expressing αSMA. It was shown that Leydig cells, when isolated in culture, began ex­pressing vinculin, and with prolonged cultivation and passaging, they acquired the Sox9 and vimentin markers. In addition, Leydig cells in culture sharply reduced their ability to secrete testosterone within a week. Based on these data, our previously developed in vitro mo­del for assessing the specific activity of drugs for spermatogenesis resto­ration was optimized and validated.

Conclusion. The approaches used enable the formation of charac­te­rized collections of different cell types isolated from the testes of la­bo­ratory animals. However, when isolated from tissue, due to the loss of a specific microenvironment, the phenotypic and functional properties of the cells may change over time in culture. This should be taken into account when creating and subsequently using cell collections. A study was conducted on the phenotype of testicular cells, as well as the secretory activity of Leydig cells. Based on this, a method for asses­sing specific activity in vitro and an optimal biobanking strategy were de­veloped.

Aim. To assess the level of circulating small non-coding ribonucleic acids (microRNAs), previously identified as differentially expressed in next-generation sequencing (NGS) profiles of various brain tumor types, using a validation cohort formed from a low-temperature plasma bank.

Material and methods. Plasma bioarchiving was performed on pa­tients treated for brain tumors at the National Medical Research Center of Oncology from April 2018 to December 2024. Reverse transcription-­polymerase chain reaction (RT-PCR) was used to determine the levels of 10 microRNAs in plasma samples from 40 individuals. Participants were divided into five groups of eight individuals as follows: those dia­gnosed with glioblastoma, astrocytoma, oligodendroglioma, benign me­ningioma, and healthy controls. The study groups included 17 wo­men and 15 men, with a median age of 52,5 years. The control group in­cluded seven women and one man, with a median age of 53 years.

Results. Plasma levels of miR-30c-5p, miR-128-3p, miR-186-5p, miR-194-5p, miR-484, miR-19b-3p, miR-431-5p, miR-3168, let-7c-5p, and miR-363-3p were determined using NGS data from 58 plasma samples (Gvaldin, 2024). The validation cohort revealed differential expression changes for four microRNAs (miR-128-3p, miR-194-5p, miR-19b-3p, and miR-363-3p) across the study groups.

Conclusion. Differential expression of circulating miR-128-3p, miR-194-5p, miR-19b-3p, and miR-363-3p is associated with brain tumor oncogenesis and can be used for their diagnosis.

Aim. To optimize a library preparation protocol for sequencing small non-coding ribonucleic acids (microRNAs) based on the commercial QIAseq miRNA UDI Library Kit to improve the quality of the obtained data.

Material and methods. Plasma and serum samples from four study participants were collected from the biobank collection of the National Medical Research Center for Therapeutic and Preventive Medicine. Ribonucleic acid (RNA) was isolated for each sample in parallel, using 200 and 300 µl aliquots. Two sequencing libraries were prepared from each RNA sample using the QIAseq miRNA UDI Library Kit by two manufacturer's protocol versions as follows: one for 1 ng of RNA with a reduced number of amplification cycles and one for 10 ng of RNA. Sequencing was performed on a NextSeq 550.

Results. When comparing groups of samples prepared using different protocol versions, there was a significant difference in the tags per million reads (TPM) per sample for human (ENCODE v47) and microRNA genes (p<0,001).

Conclusion. We showed that when using plasma and serum biosamp­les, the main parameter influencing higher microRNA sequencing rates is a reduction in the number of polymerase chain reaction cycles during library preparation.

Aim. To conduct a comparative analysis of the effectiveness of com­mer­cial kits for deoxyribonucleic acid (DNA) extraction from blood and tissue, as well as ribonucleic acid (RNA) from mouse tissue, and to eva­luate the effect of the postmortem interval (PMI) on the quality and quan­tity of extracted nucleic acids (NA).

Material and methods. Blood and tissue samples (brain, heart, liver, kid­neys, lungs, muscle, and testes) from 12 Balb/C mice were used. Samp­les were collected immediately (0 h) and 24 h after euthanasia. Ten commercial kits (Russian and international) were tested for DNA ex­trac­tion, and the RNeasy Mini Kit (Qiagen, Germany) was used for RNA extraction. Quality control included measuring the concen­tra­tion (fluorometry), purity (spectrophotometry), and integrity (electro­pho­resis) of the DNA.

Results. Spin-column-­based kits (QIAamp DNA Blood Mini Kit, Qiagen, USA, D-Blood-5) demonstrated the highest DNA yield from blood. For tissue, magnetic particle kits (GM Tissue, Tissue M) provided the highest DNA yield, but the column-­based method (QIAamp DNA Mini Kit, Qiagen, Germany) yielded better purity and stability with increasing PMI. Increasing the PMI to 24 hours resulted in a significant decrease in the concentration and integrity of both DNA and RNA in all tissues except the testes. The most pronounced RNA degradation (a decrease in RNA integrity number to 2,5-2,8) was observed in the kidneys and muscles.

Conclusion. The efficiency of NA isolation significantly depends on the type of kit, biomaterial, and PMI. The selection of the optimal method should be based on these factors. The data obtained are critical for planning the preanalytical stage of the study.

Aim. To assess the impact of long-term storage of biobanked plasma samples on the profile of circulating small non-coding ribonucleic acids (microRNAs).

Material and methods. The study included paired plasma aliquots from 10 patients from the biobank collection of the National Medical Research Center for Therapy and Preventive Medicine. The control group consisted of microRNA samples isolated 1,5 years after plasma collection and then stored in aqueous solution for 3,5 years. In the long-term plasma storage group, microRNA was isolated from a second plasma aliquot after 5 years. All samples were stored at -70 оC. Se­quen­cing was performed for both groups simultaneously on the NextSeq 550 platform (Illumina, USA) using the High Output 1×75 bp protocol.

Results. Principal component analysis based on human microRNA gene expression data (ENCODE v47) revealed heterogeneity between the study groups. In the long-term plasma storage group, compared to the control group, a significant decrease in library concentration and size was observed, as well as a more than twofold increase in expression levels for 31 microRNAs.

Conclusion. Circulating microRNAs demonstrated higher stability du­ring storage in plasma than in aqueous solution. The obtained results in­di­cate the need to consider the storage time of isolated microRNA, along with other preanalytical factors, to improve the reproducibility of micro­RNA studies.

Aim. To examine the specifics of implementing biobanking educational modules based on rotation cycles in the laboratories of the Dedov National Medical Research Center of Endocrinology for first- and second-year Endocrinology and Pediatric Endocrinology residents, as well as based on an additional extracurricular module on biobanking at the Pirogov Russian National Research Medical University.

Material and methods. This retrospective study was conducted at two sites. At the Dedov National Medical Research Center of Endocrinology, the results of the Biobank module within a laboratory rotation for 75 first- and second-year residents (specializing in Endocrinology and Pe­diatric Endocrinology) in 2023-2025, were analyzed. At the Pirogov Rus­sian National Research Medical University, the motivation and learning results of 19 first-year students who chose the additional Fun­damentals of Biobanking module were studied. Survey methods, project analysis, and statistical methods for processing analytical data were used.

Results. A low baseline level of biobanking awareness was found in both groups. After completing the module, 100% of participants ex­pres­sed a neutral or positive attitude toward biobanking. Following key mo­ti­va­tional factors were identified: for residents, career prospects (34,7% of those who completed the module were admitted to post­gra­duate education) and earning additional credits; for students, personal inte­rest in new technologies (89%) and the opportunity to visit an opera­ting biobank. The short-term modular format proved to be very effec­tive for initial immersion in biobanking.

Conclusion. The implementation of short-term educational modu­les on biobanking is an effective tool for raising awareness and foste­ring a positive attitude toward biobanks among future medical profes­sio­nals. Successful implementation depends on target audience specifics. For residents, the emphasis should be on practical and career-­oriented components, while for students — on innovation and interdisciplinarity. The data obtained substantiate the need for further integration of bio­banking principles into continuing medical education programs.

Fecal microbiota transplantation (FMT) is an effective and safe treat­ment for recurrent Clostridioides difficile infections. It is increasingly used to treat diseases pathogenetically associated with intestinal dysbiosis. Only 10% of the global demand for this treatment method is met. The growing popularity of this method necessitates the creation of fecal microbiota banks (FMBs), as they provide access to carefully screened fecal suspensions obtained from healthy donors. This review article analyzes approaches to FMB development, taking into account the legislative framework of the Russian Federation (RF), compared with regulations in North America, Europe, and the Asia-­Pacific region. Four following regulatory strategies for FMT are considered, defining the prospects for biobanking: 1) medicinal product; 2) biological pro­duct; 3) substance of human origin; 4) medical practice. Intro­ducing the approach practiced in the People's Republic of China (FMT as a medical practice) and the European Union (FMT as the use of a substance of human origin) in the Russian Federation is substantiated. The development of a FMB network will be facilitated by the national implementation of a standardized technology for collecting, processing donor material, storing, and dispensing the FMT product. Regional FMBs can be deployed at me­dical and research institutions, as well as at industrial pharmacies. Clinical and laboratory profiling of donors and recipients, including metagenomic analysis, in a national database will enable the creation of a system to support medical decision-­making and improve the efficacy and safety of FMT for the treatment of a wide range of pathologies. Developing a national FMB system will require coordinated efforts between specialized public organizations (with National Association of Biobanks and Biobanking Specialists (NASBIO)) and federal executive bodies, among which the Federal Medical and Biological Agency has the most experience with FMT and the necessary regulatory framework. A compelling advan­tage of deploying a national FMB network in Russia is the wide regional microbiome diversity, which allows for the identification of "superdonors" in conjunction with personalized FMT. The preconditions for accelerated advancement in the field of metagenomic regulation of human health have been created, and the FMB network is one of the tools for implementing this national breakthrough technology.