Development Of Biobanks Research Articles

Development of the myocite biobank: Cost-efficient model of public sector investigator-driven biobank for idiopathic inflammatory myositis

Background: Biobanking refers to the cryopreservation of the various biologic samples for future research. In the era of omics, biobanking has emerged as a vital process to aid research, more so for rare diseases. Aims and Methods: We describe herein the development of a biobank for idiopathic inflammatory myopathies (IIMs), a rheumatic illness with low prevalence. This study addresses the sample collection, transport, storage, maintenance, retrieval, and disposal of samples with a focus on cost-effectiveness, limitations, ethics, and legal aspects involved. Discussion: Financial constraints are juxtaposed next to a wealth of clinical data in the developing countries with a large population size and consequently high burden of rare diseases. Fine-tuning efforts toward the development of bio-archival facilities can maximize outcomes from research units in these countries. A time and cost-efficient model can be the first step toward such initiatives in the appropriate setting. Unique ethical, executive, and scientific challenges were encountered by the authors while establishing the MyoCite biobank in a resource-poor setting. The various efforts to foreclose these obstacles are discussed. Conclusion: This brief summarizes the unmet need, unique challenges, and potential solutions based on the authors' experiences gathered while setting up the MyoCite biobank for research in IIM. It also outlines the means and directions for national and global collaborations in the times ahead.

Перспективы развития биобанков и генетических исследований: этические аспекты

Перспективы развития биобанков и генетических исследований: этические аспекты

CURRENT BEST PRACTICES AND BIOBANKING RECOMMENDATIONS

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.

Analysis of the application mechanism of clinical biobank

Objective Analyze the application status and existed problems of clinical biobank in China, propose possible application mechanisms for clinical biobank. Methods Through questionnaire survey and case analysis combined with relevant literature reports from home and abroad, conduct qualitative analysis to understand the application status and problems of clinical biobank. Results With the rapid development of biobank, its application rate was far from expected. The construction of clinical database lags behind in China will affect the application of samples. The lag of application mechanism will affect the opening and application of the biobank. Conclusions At the beginning of construction, the clinical biobank should take full account of what and how resources can be used, and establish tailored application mechanism. More attention should be paid to the possible benefit of biobank construction. Key words: Biobank; Application; Share; Precision medicine

Registry-based Biobank Development and Integrative Physiological Analysis

Registry-based Biobank Development and Integrative Physiological Analysis

The implementation of a Biobank network for Chile

The concept "Biobank" is relatively new in the scientific literature, and is not yet consensually defined, even for the World Health Organization (WHO). However, the use of human samples in biomedical research is a very old activity. The organized development of Biobanks in different places has grown in the last decade. The experience in different countries and continents has been diverse. In this special article we intend to summarize, organize and communicate to the national medical and scientific community, (i) the concept of Biobank, (ii) the international experience and a map of the Research Biobanks working in Chile, (iii) the basic biomedical and essential operational aspects to manage a Biobank for Research and (iv) the impact of a National Network of Biobanks implementation in the Chilean Health System. Ethical and regulatory aspects will not be included, given their intrinsic complexity, which should be discussed elsewhere.

Development of a Biobank from a Legacy Collection in Universitas Gadjah Mada, Indonesia: Proposed Approach for Centralized Biobank Development in Low-Resource Institutions.

Introduction: The establishment of a biobank requires specific expertise along with relatively expensive infrastructure and appropriate technology. This causes certain challenges in biobank implementation for research in low-middle-income countries. Biobank development with established specimens and data collection (legacy collection) was an approach used in the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada. This approach aimed to identify the resources available at present, while providing nontechnical information for further development of a centralized biobank. Materials and Methods: Retrospective modeling was done in 2015 by recruiting existing specimen collections and their associated data. The steps were as follows: (1) informing research stakeholders through discussion with experts and stakeholders; (2) identifying specimen collections to be used; (3) determining the system, infrastructure, and consumables needed; (4) determining inclusion criteria; (5) building an in-house database system; (6) organizing data and physical specimen collections; and (7) validating data and physical sample arrangement. All technical procedures were built into standard operating procedures. Results: The model included specimens from one -80°C freezer. The associated data included demographic, clinical diagnosis, and physical sample information. Samples came from six studies, collected between 2001 and 2014. A web-based database was built based on the MySQL programming system. Information on biospecimens from a total of 4196 subjects collected in 11,358 vials was entered into the database, following physical rearrangement of vials in the -80°C freezer with one-dimensional barcodes taped to vials, boxes, and racks. A validation test was done for data concordance between the database and physical arrangement in the -80°C freezer, showing no discrepancies. Conclusion: This report demonstrated current technical and nontechnical insights to further develop a centralized biobank for health research at an academic institution in Indonesia.

The OncoAge Consortium: Linking Aging and Oncology from Bench to Bedside and Back Again.

It is generally accepted that carcinogenesis and aging are two biological processes, which are known to be associated. Notably, the frequency of certain cancers (including lung cancer), increases significantly with the age of patients and there is now a wealth of data showing that multiple mechanisms leading to malignant transformation and to aging are interconnected, defining the so-called common biology of aging and cancer. OncoAge, a consortium launched in 2015, brings together the multidisciplinary expertise of leading public hospital services and academic laboratories to foster the transfer of scientific knowledge rapidly acquired in the fields of cancer biology and aging into innovative medical practice and silver economy development. This is achieved through the development of shared technical platforms (for research on genome stability, (epi)genetics, biobanking, immunology, metabolism, and artificial intelligence), clinical research projects, clinical trials, and education. OncoAge focuses mainly on two pilot pathologies, which benefit from the expertise of several members, namely lung and head and neck cancers. This review outlines the broad strategic directions and key advances of OncoAge and summarizes some of the issues faced by this consortium, as well as the short- and long-term perspectives.

Legal aspects of biobanking HBS for scientific purposes in Poland

Legal issues related to the biobanking of human biological samples are one of the extremely important areas of European law. Biobanks created in Poland as well as the Polish Biobank Network created under the auspices of the Ministry of Science and Higher Education have become a catalyst for the search for solutions and the basis of rights for the functioning of biobanks in Poland as well as the protection of donor rights. Undoubtedly, the lack of legal regulation of biobanks and biomedical research on human biological samples could become a significant problem limiting the development of biobanking and conducting scientific research in Poland. The research attempts to show how representatives of the doctrine of law, bioethics and sociologists have interpreted the principles and standards of biobank operation in Poland from basic human rights, constitutional norms and personal rights.

Cross-sectional survey of cognitive status and attitude of different population about biobanking donation

Objective To understand the cognition and attitude of patients, medical staff and medical examination people on biobanks and their willingness to donation. Methods A cross-sectional study was conducted among 452 individuals, including patients, medical staff and people receiving health checkup at a hospital in Beijing from July to September, 2017.The questionnaire assessed the respondents′ demographic data, general knowledge about biobanking and the factors influencing their willingness to donate specimens to biobanks.Pearson′s Chi-square test, student t test or ANOVA were used for univariate analysis.Additionally, the linear regression analysis and logistic regression analysis were used for multivariate analyses. Results A total of 452 questionnaires were delivered, and the effective questionnaires amounted to 440, including 196 medical staff, 123 patients and 121 health checkup individuals.The awareness score of biobanks was significantly different among the medical staff, patients and health checkup individuals(P<0.05). After adjustment for potential risk factors, we found that the population characteristics and the experience of participation in a medical research were the independent beneficial factors of the awareness score.The percentage of the willingness of donation in medical staff, health checkup individuals and patients were 83.7%, 76.9% and 70.7%, respectively.The results of univariate analyses suggested that the population characteristics, education level, health conditions, the history of blood donation, and the experience of participation in a medical research were significantly associated with the willingness to donate(all P<0.05). Population characteristics and health conditions were independently relevant to the willingness of donation, after multivariate analyses of logistic regression. Conclusions Despite the strong willingness to donate biospecimens, patients and health checkup individuals lack knowledge of biobanking. It is apparent that we need to strengthen promotions and to encourage the ethics and humanities to improve the knowledge of biosample donation, for healthy development of hospital-based biobanks. Key words: Questionnaires; Biobanks; Cognition; Willingness to donate; Population

New-onset refractory status epilepticus (NORSE) and febrile infection-related epilepsy syndrome (FIRES): State of the art and perspectives.

We report the proceedings of the First International new-onset refractory status epilepticus (NORSE) and febrile infection-related epilepsy syndrome (FIRES) Symposium. To promote awareness of this condition and foster research efforts, we conveyed the First International new-onset refractory status epilepticus (NORSE) and febrile infection-related epilepsy syndrome (FIRES) Symposium. The conference was supported by The NORSE Institute (http://www.norseinstitute.org). This article summarizes the discussions that were held during the Symposium and presents our strategy to unravel the cause of these disorders and to improve patient care. The standardized definitions for these disorders that have been developed, are required to improve communication and facilitate the development of multicenter registries and biobanks. A distinction between childhood- and adult-onset forms of the syndrome is not supported by strong scientific evidence and it is argued that both should be studied together. Although the pathophysiology remains elusive, nascent evidence suggests a role for a postinfectious cytokine-mediated mechanism, which should be further investigated. It also appears important to develop tools for their early recognition and prompt treatment. Recent evidence suggests that specific electroencephalography (EEG) features might be helpful. The optimal treatment options remain to be determined; immune therapies are usually disappointing, but the ketogenic diet has proved effective in uncontrolled trials. NORSE and FIRES represent a very delicate clinical situation with specific communication issues between physicians and with patients and families. Standardized consensus definitions and a multidisciplinary multicenter strategy will help research efforts and improve clinical care for patients with NORSE and FIRES.

Biomarkers for equine joint injury and osteoarthritis.

We report the results of a symposium aimed at identifying validated biomarkers that can be used to complement clinical observations for diagnosis and prognosis of joint injury leading to equine osteoarthritis (OA). Biomarkers might also predict pre-fracture change that could lead to catastrophic bone failure in equine athletes. The workshop was attended by leading scientists in the fields of equine and human musculoskeletal biomarkers to enable cross-disciplinary exchange and improve knowledge in both. Detailed proceedings with strategic planning was written, added to, edited and referenced to develop this manuscript. The most recent information from work in equine and human osteoarthritic biomarkers was accumulated, including the use of personalized healthcare to stratify OA phenotypes, transcriptome analysis of anterior cruciate ligament (ACL) and meniscal injuries in the human knee. The spectrum of "wet" biomarker assays that are antibody based that have achieved usefulness in both humans and horses, imaging biomarkers and the role they can play in equine and human OA was discussed. Prediction of musculoskeletal injury in the horse remains a challenge, and the potential usefulness of spectroscopy, metabolomics, proteomics, and development of biobanks to classify biomarkers in different stages of equine and human OA were reviewed. The participants concluded that new information and studies in equine musculoskeletal biomarkers have potential translational value for humans and vice versa. OA is equally important in humans and horses, and the welfare issues associated with catastrophic musculoskeletal injury in horses add further emphasis to the need for good validated biomarkers in the horse. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:823-831, 2018.

The social dimension of biobanking: objectives and challenges

The present article allows to explore, analyze and reflect on the consequences and problems posed by biobanks and attempts to prove the need of social and humanitarian support in establishing and functioning of biobanks as a new type of scientific institutions. The basis of the article is the latest publications devoted to social and humanitarian aspects of biobanking and Russian experience of the initial formation of this subject domain (before the first professional biobanks were established in Russia in the 2010-s, the only highly specialized collections of bio-samples had been registered). The article marks and classifies different aspects of biobanking that objectively demands the participation of specialists in ethics and social sciences. The cases of biobanking development and risks are estimated; the objective need of applied ethics and social sciences specialists’ participation in biobanking is proved.

The role of scientific research management department in the construction of biobank

Objective To explore and identify the role of scientific research management departmentin the construction of biobank, discuss problems encountered and possible strategies. Methods Our hospital scientific research management department actively involved, and played an important role in the coordination work for hardware and software construction during the setting up of Infectious disease biorepository.A series of institutional policies and procedures were developed, such as organizational structure of the biobank, sample collection rules at the clinic and research achievementtransformation guidelines. Results A total of 500-case samples were collected, involving different kinds of infectious diseases, like HBV, HCV and HIV. The biobank undertook the Science and Technology Resources Platform Construction Projectof Tianjin health and Family Planning Commission, also established collaboration relationships with domestic and foreign scientific research institutions andhospitals like Memorial University of Newfoundland. Conclusions Scientific research management department should play an important role in the construction of biobank and lay a solid foundation for the development of the biobank. Key words: Translational medicine; Biobank; Infectious disease; Medical science research department

CKD.QLD: establishment of a chronic kidney disease [CKD] registry in Queensland, Australia

BackgroundChronic kidney disease [CKD] is recognised as a global public health problem. Until recently, the majority of information informing on CKD has been generated from renal registries reporting on patients with end-stage kidney disease [ESKD] and on renal replacement therapy [RRT]. There has been a paucity of information on pre-dialysis CKD cohorts, and many issues related to these poorly described populations are unresolved. To this end, international organizations have called for CKD surveillance systems across all countries.DescriptionIn Australia, we have responded by developing the Chronic Kidney Disease in Queensland [CKD.QLD] with three main platforms consisting of CKD Registry, clinical trials and development of biobank. This registry which is the core component of CKD surveillance was conceptualized specifically for the pre-dialysis population in the public health system in Queensland, Australia. Recruitment started in May 2011, and to date the Registry has evolved as one of the largest CKD cohorts in the world with recruitment close to 7000 patients. The Registry has had many outcomes, including being the nidus for Australia’s first National Health and Medical Research Council [NHMRC] CKD Centre of Research Excellence [CKD.CRE].ConclusionsThe Registry, with its linkage to Queensland Health datasets, is reporting, and is expected to continue generating, significant information on multiple aspects of CKD, its trajectory, management and patient outcomes. Intent of the CKD.CRE is to facilitate an expanded Registry network that has representation from health services, both public and private, across Australia.

Analysis for the clinical biobanks sustainable development and influence factors

Objective Analysis the clinical biobanks sustainable development and influence, and give some advices for the development of clinical biobanks. Methods By review the development of Beijing Biobank of Clinical Resources, and combined with the related literature, we analysis the clinical biobanks sustainable development and influence. Results With the rapid development of the biobank, its sustainable development has attracted more and more attention, and is influenced by sharing, funds, staff, information, strategies and policies. Conclusions The sustainable development of clinical biobanks is facing more and more challenges. For the sustainable development of clinical biobanks, the constructer should be focus on the requirement from the research, and pay attention to the interests of stakeholders. Key words: Biobank; Sustainable development; Sample sharing; Precision medicine

Phenome-wide association studies: a new method for functional genomics in humans.

In experimental physiological research, a common study design for examining the functional role of a gene or a genetic variant is to introduce that genetic variant into a model organism (such as yeast or mouse) and then to search for phenotypic consequences. The development of DNA biobanks linked to dense phenotypic information enables such an experiment to be applied to human subjects in the form of a phenome-wide association study (PheWAS). The PheWAS paradigm takes advantage of a curated medical phenome, often derived from electronic health records, to search for associations between 'input functions' and phenotypes in an unbiased fashion. The most commonly studied input function to date has been single nucleotide polymorphisms (SNPs), but other inputs, such as sets of SNPs or a disease or drug exposure, are now being explored to probe the genetic and phenotypic architecture of human traits. Potential outcomes of these approaches include defining subsets of complex diseases (that can then be targeted by specific therapies) and drug repurposing.

Biobanks as the basis for developing biomedicine: Problems and prospects

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.

A Systematic Evaluation of Blood Serum and Plasma Pre-Analytics for Metabolomics Cohort Studies.

The recent thriving development of biobanks and associated high-throughput phenotyping studies requires the elaboration of large-scale approaches for monitoring biological sample quality and compliance with standard protocols. We present a metabolomic investigation of human blood samples that delineates pitfalls and guidelines for the collection, storage and handling procedures for serum and plasma. A series of eight pre-processing technical parameters is systematically investigated along variable ranges commonly encountered across clinical studies. While metabolic fingerprints, as assessed by nuclear magnetic resonance, are not significantly affected by altered centrifugation parameters or delays between sample pre-processing (blood centrifugation) and storage, our metabolomic investigation highlights that both the delay and storage temperature between blood draw and centrifugation are the primary parameters impacting serum and plasma metabolic profiles. Storing the blood drawn at 4 °C is shown to be a reliable routine to confine variability associated with idle time prior to sample pre-processing. Based on their fine sensitivity to pre-analytical parameters and protocol variations, metabolic fingerprints could be exploited as valuable ways to determine compliance with standard procedures and quality assessment of blood samples within large multi-omic clinical and translational cohort studies.

Biobank development in the context of precision medicine: roadblocks and countermeasures

Introduced in this paper are the current situation of biobank in China in the context of precision medicine.As a vital platform of precision medicine, biobank constitutes a resource support for this plan.Establishing high quality biobank has important implications for the implement of precision medicine in China.This paper focused on the problems existing in biobank development in the context of precision medicine and put forward corresponding countermeasures as well as suggestions. Key words: Precision medicine; Biobank; Quality control