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BioTech
Special Issues
Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation
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Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation

A special issue of BioTech (ISSN 2673-6284). This special issue belongs to the section "Biotechnology Regulation".

Deadline for manuscript submissions: closed (31 December 2021) | Viewed by 24681

Special Issue Editor

Dr. Luciana Caenazzo

E-Mail Website
Guest Editor
Department of Molecular Medicine, University of Padua, Via Falloppio 50, 35121 Padova, Italy
Interests: clinical genetics; molecular diagnostic; molecular analysis (DNA and mRNA) applied to human identification
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

The term biobank refers to a large, organized collection for research purposes of well-characterized samples with associated biological and medical data, with the purpose of underpinning and facilitating medical research efforts by providing high-quality, research-ready samples together with linked clinical data, according to a set of best practices and standards. However, today, the exponential added value is in the linked data and the clinical information that relates to them. The consequence is that it is important to consider the growing demand for high-quality and clinically annotated biospecimens due to genomic, post-genomic, and personalized medicine research activities. In this perspective, it is of paramount importance to consider the major problems related to the decentralized evolution of biobanking, such heterogeneous procedures for specimen collection and storage, issues related to specimen access, handling of all the data, biobank sustainability due to rising costs for personnel, equipment, sample storage, and establishment of new (standard) methods, and the novel field of imaging biobanks.

As biobanks are important sources for the provision of research-ready tissue as well as associated data, they can face a dual bottleneck of analytical laboratory harmonization and analytical data curation. These aspects are interconnected, and both can directly affect the biobank utilization rates.

This Special Issue invites papers exploring how new trends are being applied to biobanks, including critical perspectives on upcoming challenges, for example:

  1. Laboratory research trough biobanks;
  2. Biobank sustainability;
  3. New form of biological samples collection, processing, and storage;
  4. Recent advances in health research and technology on the types of samples and data provided by biobanks;
  5. Imaging biobanks;
  6. Systems for data protection in biobanking;
  7. Analytical laboratory harmonization;
  8. Analytical data curation.

Dr. Luciana Caenazzo
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. BioTech is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • biobanks
  • harmonization
  • biospecimens
  • data protection
  • laboratory

Published Papers (6 papers)

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Research

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7 pages, 1012 KiB  
Article
New Challenges for Biobanks: Accreditation to the New ISO 20387:2018 Standard Specific for Biobanks
by Pasquale De Blasio and Ida Biunno
BioTech 2021, 10(3), 13; https://doi.org/10.3390/biotech10030013 - 02 Jul 2021
Cited by 14 | Viewed by 4572
Abstract
Background: The emergence of “multi-omics” and “multi-parametric” types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality “Biological Materials and Associated Data” (BMaD). To meet the demands of biomedical research, several Biological Resource Centers [...] Read more.
Background: The emergence of “multi-omics” and “multi-parametric” types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality “Biological Materials and Associated Data” (BMaD). To meet the demands of biomedical research, several Biological Resource Centers (BRCs) or Biobanks world-wide have implemented a specific Quality Management System (QMS) certified ISO 9001:2015 or accredited by CAP9 ISO 20387:2018. For the first time, ISO, with the support of several Biobanking experts, issued the ISO 20387:2018 which is the first ISO norm specific for Biobanks. The fundamental difference with present certification/accreditation standards is that the ISO 20387:2018 focuses not only on the operational aspects of the Biobank, but also on the “competence of the Biobank to carry our specific Biobanking tasks”. Methods: The accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks. Results: The accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines. Conclusion: Accreditation is given by an accreditation body, which recognizes formally that the Biobank is “competent to carry out specific Biobanking tasks”. Full article
(This article belongs to the Special Issue Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation)
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13 pages, 1070 KiB  
Article
Harmonization of Biobank Education for Biobank Technicians: Identification of Learning Objectives
by Mara Lena Hartung, Ronny Baber, Esther Herpel, Cornelia Specht, Daniel Peer Brucker, Anne Schoneberg, Theresa Winter and Sara Yasemin Nussbeck
BioTech 2021, 10(2), 7; https://doi.org/10.3390/biotech10020007 - 14 Apr 2021
Cited by 6 | Viewed by 3383
Abstract
The quality of biospecimens stored in a biobank depends tremendously on the technical personnel responsible for processing, storage, and release of biospecimens. Adequate training of these biobank employees would allow harmonization of correct sample handling and thus ensure a high and comparable quality [...] Read more.
The quality of biospecimens stored in a biobank depends tremendously on the technical personnel responsible for processing, storage, and release of biospecimens. Adequate training of these biobank employees would allow harmonization of correct sample handling and thus ensure a high and comparable quality of samples across biobank locations. However, in Germany there are no specific training opportunities for technical biobank staff. To understand the educational needs of the technical personnel a web-based survey was sent to all national biobanks via established e-mail registers. In total, 79 biobank employees completed the survey, including 43 technicians. The majority of the participating technical personnel stated that they had worked in a biobank for less than three years and had never participated in an advanced training. Three-quarters of the technicians indicated that they were not able to understand English content instantly. Based on these results and the results of a workshop with 16 biobank technicians, 41 learning objectives were formulated. These learning objectives can be used as a basis for advanced training programs for technical personnel in biobanks. Setting up courses based on the identified learning objectives for this group of biobank staff could contribute to harmonization and sustainability of biospecimen quality. Full article
(This article belongs to the Special Issue Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation)
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11 pages, 1282 KiB  
Article
The Andalusian Registry of Donors for Biomedical Research: Five Years of History
by Rocío Aguilar-Quesada, Inés Aroca-Siendones, Leticia de la Torre, Sonia Panadero-Fajardo, Juan David Rejón, Ana María Sánchez-López and Blanca Miranda
BioTech 2021, 10(1), 6; https://doi.org/10.3390/biotech10010006 - 12 Mar 2021
Cited by 1 | Viewed by 3251
Abstract
The mission of the Andalusian Public Health System Biobank is to offer the best options for biological samples of human origin and associated clinical information, protecting the rights of citizens who donate their samples for research. Since the Andalusian Biobank provides high-quality biological [...] Read more.
The mission of the Andalusian Public Health System Biobank is to offer the best options for biological samples of human origin and associated clinical information, protecting the rights of citizens who donate their samples for research. Since the Andalusian Biobank provides high-quality biological samples of all types in a specified format, adapting the preanalytical phase according to the requirements of the research, prospective collection and distribution of samples are being prioritized in order to contribute to the sustainability of the Biobank. The Andalusian Registry of Donors for Biomedical Research is a tool for the recruitment of donors and the prospective collection of samples. Its operation is based on the informed consent of donors for their incorporation into the Registry and contact with possible donors under request from specific projects. An additional advantage of this unique initiative is to ensure that societal actors work together throughout the entire research process, establishing alliances with patient associations and groups to develop joint actions and promote biomedical research. Here, we describe the creation, ethical–legal aspects, management and results of the Andalusian Registry of Donors for Biomedical Research after five years of operation. Full article
(This article belongs to the Special Issue Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation)
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Review

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20 pages, 640 KiB  
Review
A Systematic Review of Oral Biopsies, Sample Types, and Detection Techniques Applied in Relation to Oral Cancer Detection
by Guanghuan Yang, Luqi Wei, Benjamin K. S. Thong, Yuanyuan Fu, Io Hong Cheong, Zisis Kozlakidis, Xue Li, Hui Wang and Xiaoguang Li
BioTech 2022, 11(1), 5; https://doi.org/10.3390/biotech11010005 - 02 Mar 2022
Cited by 13 | Viewed by 5202
Abstract
Background: Early identification of the stage of oral cancer development can lead to better treatment outcomes and avoid malignant transformation. Therefore, this review aims to provide a comprehensive overview that describes the development of standardized procedures for oral sample collection, characterization, and molecular [...] Read more.
Background: Early identification of the stage of oral cancer development can lead to better treatment outcomes and avoid malignant transformation. Therefore, this review aims to provide a comprehensive overview that describes the development of standardized procedures for oral sample collection, characterization, and molecular risk assessment. This can help investigators to choose the appropriate sampling method and downstream analyses for different purposes. Methods: This systematic review was conducted according to the PRISMA guidelines. Using both PubMed and Web of Science databases, four independent authors conducted a literature search between 15 and 21 June 2021. We used key search terms to broaden the search for studies. Non-conforming articles were removed using an EndNote-based and manual approach. Reviewers used a designed form to extract data. Results: This review included a total of 3574 records, after eliminating duplicate articles and excluding papers that did not meet the inclusion criteria. Finally, 202 articles were included in this review. We summarized the sampling methods, biopsy samples, and downstream analysis. The biopsy techniques were classified into tissue and liquid biopsy. The common sequential analysis of tissue biopsy includes histopathological examination such as H&E or IHC to identify various pathogenic features. Meanwhile, liquid samples such as saliva, blood, and urine are analyzed for the purpose of screening to detect mutations in cancer. Commonly used technologies are PCR, RT-PCR, high-throughput sequencing, and metabolomic analysis. Conclusions: Currently, tissue biopsies provide increased diagnostic value compared to liquid biopsy. However, the minimal invasiveness and convenience of liquid biopsy make it a suitable method for mass screening and eventual clinical adoption. The analysis of samples includes histological and molecular analysis. Metabolite analysis is rising but remains scarce. Full article
(This article belongs to the Special Issue Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation)
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Other

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12 pages, 268 KiB  
Commentary
Oocyte Biobanks: Old Assumptions and New Challenges
by Pamela Tozzo
BioTech 2021, 10(1), 4; https://doi.org/10.3390/biotech10010004 - 18 Feb 2021
Cited by 4 | Viewed by 2823
Abstract
The preservation of fertility is a clinical issue that has been emerging considerably in recent decades, as the number of patients of childbearing age who risk becoming infertile for many reasons is increasing. The cryopreservation technique of oocytes has been developed for many [...] Read more.
The preservation of fertility is a clinical issue that has been emerging considerably in recent decades, as the number of patients of childbearing age who risk becoming infertile for many reasons is increasing. The cryopreservation technique of oocytes has been developed for many years and nowadays constitutes a method of safe storage with impressive efficacy and high rates of successful thawing. The storage and use for research of oocytes taken for medical or non-medical can be carried out by both public and private structures, through egg sharing, voluntary egg donation and so-called “social freezing” for autologous use. This paper focuses on the oocyte bank as an emerging cryopreservation facility, in which a collaboration between public and private and the creation of a network of these biobanks can be useful in enhancing both their implementation and their functions. Good oocyte biobank practice would require that they be collected, stored, and used according to appropriate bioethical and bio-law criteria, collected and stored according to procedures that guarantee the best preservation of their structural components and a high level of safety, connected with appropriate procedures to protect the rights and privacy of the parties involved and associated with the results of the bio-molecular investigations that will be carried out gradually. Full article
(This article belongs to the Special Issue Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation)
6 pages, 193 KiB  
Commentary
The Future of Biobanking: What Is Next?
by Luciana Caenazzo and Pamela Tozzo
BioTech 2020, 9(4), 23; https://doi.org/10.3390/biotech9040023 - 23 Nov 2020
Cited by 13 | Viewed by 3774
Abstract
Biobanks are an extraordinary tool for research and scientific progress. Since their origin, the debate on the main technical, regulatory and ethical aspects has not stopped. The future of biobanks should take into account many factors: the need to improve the technical standards [...] Read more.
Biobanks are an extraordinary tool for research and scientific progress. Since their origin, the debate on the main technical, regulatory and ethical aspects has not stopped. The future of biobanks should take into account many factors: the need to improve the technical standards of collection, conservation and use of the sample, the usefulness of achieving forms of harmonization and common governance, the improvement of biobank networks, including through public–private partnerships and improving the sustainability of these infrastructures. Full article
(This article belongs to the Special Issue Recent Advances in Biobanking: New Perspectives from Laboratory to Regulation)
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