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Guideline on Valuation of Research Biospecimen Collections. 研究生物标本收藏估价指南。
IF 1.6 4区 生物学 Pub Date : 2025-04-08 DOI: 10.1089/bio.2024.0159
Amanda Rush, Jennifer A Byrne, Peter H Watson

Biobanks can consume a lot of financial resources and some biobanks have a poor record of utilization. This suggests the need for better planning by these biobanks around what new biospecimens to collect and store and more deliberate approaches to determine the value of existing biospecimen collections to make operational decisions. Existing biospecimen collections may comprise part of the biobank inventory (where decisions are needed around availability or continued storage) or external collections (where decisions are needed to consider their addition to the inventory). However, there has been limited discussion about how to value these collections. This paper proposes a guideline for the valuation of existing collections based on a two-stage process that involves consideration of features under two broad categories: "ELSI" factors and "Biospecimen and Data" factors. The first "initial-valuation" stage is based on the consideration of five key questions related to each of the main factors and will, in many instances, suffice. This approach can identify salient features of a collection that may have a dominant impact on the value. However, in other instances, a second "extended-valuation" stage may be needed to make a more in-depth assessment of the features of a collection. The overall value can then be summarized and/or assigned a score and compared with valuations of comparable collections. The latter might include another collection occupying a similar storage volume within the biobank, a collection from a similar group of donors, or a similar collection stored by another affiliated biobank. In summary, we hope that these guidelines and discussion serve to highlight key factors and an approach to valuing existing collections to improve biobanking efficiency and sustainability.

生物库会消耗大量的财政资源,一些生物库的利用记录很差。这表明,这些生物库需要更好地规划收集和储存哪些新的生物标本,以及采用更审慎的方法来确定现有生物标本收藏的价值,从而做出运营决策。现有的生物标本收集可能包括生物库清单的一部分(需要围绕可用性或继续储存做出决定)或外部收集(需要考虑将其添加到清单中)。然而,关于如何评价这些藏品的讨论却很有限。本文提出了一种基于两阶段过程的现有馆藏评估指南,该过程涉及考虑两大类特征:“ELSI”因素和“生物标本和数据”因素。第一个“初步估价”阶段以审议与每一主要因素有关的五个关键问题为基础,在许多情况下就足够了。这种方法可以识别可能对价值有主要影响的集合的显著特征。但是,在其他情况下,可能需要第二个“扩展估价”阶段,以便对藏品的特征进行更深入的评估。然后可以总结总体价值和/或分配一个分数,并与可比收藏品的估值进行比较。后者可能包括在生物库中占用类似存储容量的另一个集合,来自类似供体组的集合,或由另一个附属生物库存储的类似集合。总之,我们希望这些指导方针和讨论有助于突出关键因素和评估现有馆藏的方法,以提高生物库的效率和可持续性。
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引用次数: 0
Usage of the Terms "Biorepository" and "Biobank": A Process to Achieve a Working Definition Among Global Partners. 术语“生物库”和“生物库”的使用:在全球合作伙伴之间实现工作定义的过程。
IF 1.6 4区 生物学 Pub Date : 2025-04-03 DOI: 10.1089/bio.2024.0116
Zoe Steinberg, Judith Giri, Anyela Lozano-Parra, Gustavo Aldopho Gómez, Laura Pezzi, Van-Mai Cao-Lormeau, Md Moyeen Chowdhury, Ibrahim Swaray, Ecaterina Noroc, Elena Romancenco, Inès Vigan-Womas, Ousmane Noël Diallo, Kareen Arias, David Perera, Mong How Ooi, Jajah Fachiroh, Amy Price, Julia Poje, Nikaash Pasnoori, May Chu
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引用次数: 0
Transport Media for Live Skin Tissue from Gray-Brocket Deer (Subulo gouazoubira). 灰花鹿活体皮肤组织的运输介质。
IF 1.6 4区 生物学 Pub Date : 2025-03-27 DOI: 10.1089/bio.2024.0139
Eluzai Dinai Pinto Sandoval, José Maurício Barbanti Duarte

Sampling skin fragments has been an important strategy for genetic studies and ex situ conservation, aiding in the preservation of genetic diversity in Neotropical deer and other wild species. From the moment of collection in the field, transport media must ensure tissue viability by providing the necessary nutrients until laboratory processing for culture or cryopreservation. This study aimed to evaluate the effects of temperature and storage duration on tissue viability and cell growth using two types of skin transport media: Dulbecco's modified Eagle medium (DMEM) supplemented with 15% fetal bovine serum and 0.9% physiological saline solution. Skin fragments were collected from the inguinal region of five captive gray-brocket deer (Subulo gouazoubira) and divided into small samples, which were randomly assigned to each transport medium. The samples were stored at 5°C and 24°C for 24 and 72 hours, followed by cryopreservation and thawing to assess histomorphology, apoptosis (TUNEL test), cell growth, viability (Trypan blue and MTT assay), and mitotic index. The results showed that physiological saline solution is as efficient as DMEM in maintaining tissue viability, with 80% of viable cells observed and no significant difference after storing in different skin transport media (p > 0.05). Cell morphology and apoptosis did not change in response to media, temperature, or storage duration. We recovered metaphases from all skin tissue storing conditions, with a similar mitotic index to those presented in other cell culture studies from deer biopsies. These results showed the feasibility of storing skin tissue samples during 24 and 72 hours at 5°C and 24°C in different transport media guaranteeing the cell growth and viability for genetic studies and reproductive biotechnologies. The study may contribute to sampling collection in places where displacement with large equipment is limited, allowing the establishment of simplified skin transport protocols as an important step to accessing genetic material from individuals inhabiting isolated localities.

皮肤碎片取样是遗传研究和迁地保护的重要策略,有助于保护新热带鹿和其他野生物种的遗传多样性。从现场收集的那一刻起,运输培养基必须通过提供必要的营养来确保组织的活力,直到实验室处理培养或冷冻保存。本试验采用添加15%胎牛血清和0.9%生理盐水的Dulbecco's modified Eagle培养基(DMEM)作为皮肤运输介质,研究温度和储存时间对组织活力和细胞生长的影响。从5只圈养灰花鹿(Subulo gouazoubira)的腹股沟区域收集皮肤碎片,并将其分成小样本,随机分配到每种运输介质中。在5°C和24°C下分别保存24和72小时,然后冷冻和解冻,评估组织形态学、凋亡(TUNEL试验)、细胞生长、活力(台盼蓝和MTT试验)和有丝分裂指数。结果表明,生理盐水溶液与DMEM一样能有效维持组织活力,80%的活细胞在不同皮肤运输介质中保存后无显著差异(p > 0.05)。细胞形态和凋亡不受培养基、温度或储存时间的影响。我们从所有皮肤组织储存条件中恢复了中期,有丝分裂指数与其他鹿活组织细胞培养研究中出现的有丝分裂指数相似。这些结果表明,在5°C和24°C的不同运输介质中保存皮肤组织样品24和72小时的可行性,保证了细胞的生长和遗传研究和生殖生物技术的活力。该研究可能有助于在大型设备迁移有限的地方进行采样收集,从而允许建立简化的皮肤运输协议,作为从居住在隔离地区的个体获取遗传物质的重要步骤。
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引用次数: 0
Biobanking in Sub-Saharan Africa: A Review of Data Protection Frameworks. 撒哈拉以南非洲的生物银行:数据保护框架综述。
IF 1.6 4区 生物学 Pub Date : 2025-03-25 DOI: 10.1089/bio.2024.0086
Anoosh Mohammadzadeh, Samira Farjaminejad, Poonam Patel, Sandra Nanyonga, Raheelah Ahmad, Charitini Stavropoulou, Zisis Kozlakidis

Introduction: Biobanks are a foundational infrastructure supporting research at scale and contributing to scientific progress. The increasing collection of samples and associated data presents challenges in terms of both physical and digital storage and handling. In North America and Europe health data protection frameworks have been in place for several years, regulating the use of collected personal data, including health care data, as those typically used by human biobanks. Yet, regulatory frameworks for biobanking, particularly in low- and middle-income settings, are highly fragmented, and little is known in this area. Objectives: This review focuses on identifying the health-related data protection frameworks in sub-Saharan African countries, as they are relevant to biobanking. Methods: We used complementary literature review approaches to ensure the completeness of our results for biobanking identified as "African," as well as for "disease-based," "country-based," and artificial intelligence-based approaches. Results: In total, 56 articles were identified and reviewed in full, 31 health-related acts and frameworks relevant to biobanking, and 24 general data protection acts and frameworks from 37 countries. In some countries, such as Kenya and Zambia, these acts were implemented, in some others, they were not. In most cases, as these regulatory frameworks have been recently created and implemented, there are little or no data relating to the impact of their implementation. Conclusion: Our findings confirm that regulatory frameworks for biobanking in sub-Saharan Africa are still in a consistent period of emergence, in an effort by national governments to address the existing fragmented landscape and support the development of research.

生物库是支持大规模研究和促进科学进步的基础设施。越来越多的样本和相关数据的收集在物理和数字存储和处理方面都提出了挑战。在北美和欧洲,健康数据保护框架已经建立了数年,对收集的个人数据(包括医疗保健数据)的使用进行了规范,就像人类生物银行通常使用的那样。然而,生物银行的监管框架,特别是在低收入和中等收入环境中,是高度分散的,在这一领域知之甚少。目标:本次审查的重点是确定撒哈拉以南非洲国家与健康相关的数据保护框架,因为它们与生物银行相关。方法:我们使用互补的文献综述方法来确保我们的结果的完整性,这些结果被确定为“非洲”生物银行,以及“基于疾病”、“基于国家”和基于人工智能的方法。结果:总共确定并全文审查了56篇文章、31项与生物银行相关的健康相关法案和框架,以及来自37个国家的24项一般数据保护法案和框架。在一些国家,例如肯尼亚和赞比亚,这些行动得到了执行,而在另一些国家则没有。在大多数情况下,由于这些监管框架是最近才创建和实施的,因此很少或根本没有与实施影响相关的数据。结论:我们的研究结果证实,在撒哈拉以南非洲国家政府的努力下,生物银行的监管框架仍处于持续出现的时期,以解决现有的碎片化景观并支持研究的发展。
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引用次数: 0
Recruitment Strategies for a Nonhospital-Based Academic Rare Disease Biobank in South Africa. 南非非医院罕见病学术生物库的招聘策略。
IF 1.6 4区 生物学 Pub Date : 2025-03-24 DOI: 10.1089/bio.2024.0140
Engela H Conradie, Varushka Acton, Albe C Swanepoel

Introduction: Rare disease research in South Africa (SA) faces significant challenges, including limited prioritization and awareness, which hinder advancements in patient care and scientific discovery. This article explores the recruitment strategies employed by the Centre for Human Metabolomics (CHM) Biobank, a nonhospital-based academic rare disease biobank, to address these challenges. Methods: We explain the consent process and documents as well as the three recruitment models employed, namely (1) Recruitment via referring clinician, (2) implementation of monthly diagnostic follow-up sessions, and (3) recruitment of patients for specific projects through clinic-based recruitment drives. Discussion: We discuss the benefits as well as the challenges of each model. Challenges included clinician and patient time constraints, distrust from current consent practices, and limited public awareness. We elaborate on future strategies to address these gaps such as simplifying consent, expanding recruitment sites, collaborating with clinical, academic and public institutions, and raising public awareness of the role of the CHM Biobank. Conclusions: From the models employed over the past 5 years, it is evident that recruitment is most effective when patients perceive a direct benefit, such as involvement in active projects. These strategies outlined in the discussion are crucial for ensuring the CHM Biobank's sustainability, diversity, and its impact on scientific research and patient outcomes in SA.

导言:南非(SA)的罕见病研究面临着重大挑战,包括优先级和认知度有限,这阻碍了患者护理和科学发现的进步。本文探讨了人类代谢组学中心 (CHM) 生物库(一个非医院性质的罕见病学术生物库)为应对这些挑战而采取的招募策略。方法:我们解释了同意程序和文件以及所采用的三种招募模式,即(1)通过转诊临床医生招募;(2)实施每月诊断随访;(3)通过诊所招募活动为特定项目招募患者。讨论:我们讨论了每种模式的优势和挑战。面临的挑战包括临床医生和患者的时间限制、对当前同意做法的不信任以及公众意识有限。我们阐述了解决这些问题的未来策略,如简化同意程序、扩大招募地点、与临床、学术和公共机构合作以及提高公众对 CHM 生物库作用的认识。结论:从过去 5 年所采用的模式中可以看出,当患者能直接获益时,如参与积极的项目时,招募工作最为有效。讨论中概述的这些策略对于确保南澳 CHM 生物库的可持续性、多样性及其对科学研究和患者治疗效果的影响至关重要。
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引用次数: 0
Green Biobanking-Not Just Managing the Storage System but Also the Storage Footprint. 绿色生物银行——不仅管理存储系统,还要管理存储足迹。
IF 1.6 4区 生物学 Pub Date : 2025-03-20 DOI: 10.1089/bio.2025.0005
Peter H Watson
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引用次数: 0
Experts Speak Forum: Decarbonization for Green Biobanking-The Current Landscape and Challenges for the Future. 专家演讲论坛:绿色生物银行的脱碳-当前景观和未来的挑战。
IF 1.6 4区 生物学 Pub Date : 2025-03-20 DOI: 10.1089/bio.2024.0128
Koh Furuta, Hanh Vu, Daniel Adamek, Armin Ahmadi, Jerome Baudry, Jajah Fachiroh, Neil Fleshner, Gregory H Grossman, Paul Hofman, Marius Ilie, Zisis Kozlakidis, Birendra Kumar Yadav, Elodie Long-Mira, Vineetha Menon, Wayne Ng, Lee Organick, Swee Heng Milon Pang, Naghmeh Rastegar, Ryo Shirakashi, Tiiu Sildva, Heidi Wagner, Koh Furuta

This article provides an update on the current state of decarbonization efforts in biobanking, reflecting on the evolving discussions at the annual meetings of the International Society for Biological and Environmental Repositories (ISBER). Following roundtable discussions at the 2021 and 2023 meetings, the 2024 ISBER meeting, which was held in Melbourne, Australia, featured a symposium, workshop, and posters dedicated to decarbonization, highlighting its growing significance on a global scale. The introduction of the term "green biobanking" at this meeting marked a pivotal moment, revealing that current decarbonization efforts in biobanking are largely piecemeal and lack a comprehensive, strategic approach. The goal of this article is to clarify the concept of green biobanking and update the community on the latest developments, while carefully outlining potential pathways for future innovation without pressuring biobankers to adopt existing technologies. The discussion includes insights from experts across various sectors. These include experts from the World Health Organization, biobanks in high-income countries, and low- and middle-income countries, as well as from the Canadian academia, preservation technology, industry, artificial intelligence, and education sectors. The authors emphasize the need for collaboration among all stakeholders to drive the field forward through creative disruption and pave the way for a sustainable future in biobanking.

本文提供了生物银行脱碳工作的最新现状,反映了国际生物与环境资源库学会(ISBER)年会上不断发展的讨论。继2021年和2023年会议的圆桌讨论之后,在澳大利亚墨尔本举行的2024年ISBER会议以专题讨论会、讲习班和海报为特色,强调了其在全球范围内日益增长的重要性。在这次会议上,“绿色生物银行”一词的引入标志着一个关键时刻,它揭示了目前生物银行的脱碳努力在很大程度上是零散的,缺乏全面的战略方法。本文的目的是澄清绿色生物银行的概念,并向社会更新最新的发展,同时仔细概述未来创新的潜在途径,而不会迫使生物银行采用现有技术。讨论包括来自各个部门的专家的见解。其中包括来自世界卫生组织、高收入国家、低收入和中等收入国家生物库的专家,以及来自加拿大学术界、保存技术、工业、人工智能和教育部门的专家。作者强调需要所有利益相关者之间的合作,通过创造性的颠覆来推动该领域的发展,并为生物银行的可持续未来铺平道路。
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引用次数: 0
Evaluating Cryopreservation Methods in Biobanking: Impacts on Biomarker Integrity and Omics Data Reliability. 评估生物银行冷冻保存方法:对生物标志物完整性和组学数据可靠性的影响。
IF 1.6 4区 生物学 Pub Date : 2025-03-18 DOI: 10.1089/bio.2024.0141
Annamaria Antona, Valentina Bettio, Jacopo Venetucci, Silvia Vittoria Cracas, Eleonora Mazzucco, Giulia Garro, Marco Varalda, Carolina Fontanarosa, Michele Spinelli, Angela Amoresano, Roberta Rolla, Daniela Capello

Objectives: Personalized medicine emphasizes prevention and early diagnosis by developing genetic screening and biomarker assessment tools. Biobanks, including University of Piemonte Orientale (UPO) Biobank, support this effort by providing high-quality biological samples collected, processed, and stored using optimized standardized protocols. To determine the optimal long-term storage conditions for biospecimens used in biomedical research, we evaluated plasma and serum samples cryopreserved using two storage methods, cryovials and straws, across various analytical methodologies with differing sensitivity and robustness. Design and Methods: Plasma and serum samples cryopreserved in liquid nitrogen in vials and straw at the UPO Biobank were subjected to multiple analyses including standard biochemical laboratory analysis, targeted lipidomics, untargeted proteomics, and targeted metabolites quantification through mass spectrometry-based analytical techniques. Results: Our data demonstrate the robustness and applicability of both storage methods for standard laboratory analyses in evaluating clinically relevant markers in plasma and serum. Lipidomic analysis revealed slight disparities in lipid abundance, though these differences were mostly confined to specific lipid species, particularly fatty acids. Conversely, proteomic and metabolomic analyses uncovered variations in abundance in a significant, albeit limited, fraction of analytes between vials and straw-derived samples. Conclusions: By highlighting similarities and differences in samples stored in these conditions, this study provides significant insights into optimizing biobanking practices and understanding the factors that influence the integrity of cryopreserved biospecimens and the reliability of the data derived from them. Both straws and vials are convenient and efficient cryopreservation methods, essentially equivalent for samples dedicated to robust and relatively low-sensitive standardized analyses. However, our findings emphasize the need for caution when interpreting omics data from samples subjected to different cryopreservation methods, as subtle variations can arise even with different types of containers.

目的:个性化医学强调通过开发遗传筛查和生物标志物评估工具进行预防和早期诊断。包括东方皮埃蒙特大学(UPO)生物样本库在内的生物样本库通过提供使用优化的标准化协议收集、处理和存储的高质量生物样本来支持这一努力。为了确定生物医学研究中使用的生物标本的最佳长期储存条件,我们评估了使用两种储存方法(低温瓶和吸管)冷冻保存的血浆和血清样本,采用不同的分析方法,具有不同的灵敏度和鲁棒性。设计与方法:在UPO生物银行液氮瓶和吸管中低温保存的血浆和血清样本进行多项分析,包括标准生化实验室分析,靶向脂质组学,非靶向蛋白质组学,以及基于质谱的分析技术的靶向代谢物定量。结果:我们的数据证明了两种存储方法在评估血浆和血清中临床相关标记物的标准实验室分析中的稳健性和适用性。脂质组学分析揭示了脂质丰度的轻微差异,尽管这些差异主要局限于特定的脂质种类,特别是脂肪酸。相反,蛋白质组学和代谢组学分析发现,在小瓶和吸管提取的样品之间,尽管有限,但相当一部分分析物的丰度存在差异。结论:通过强调在这些条件下保存的样品的相似性和差异性,本研究为优化生物银行实践和理解影响冷冻保存生物标本完整性的因素以及从中获得的数据的可靠性提供了重要的见解。吸管和小瓶都是方便和有效的冷冻保存方法,基本上等同于用于稳健和相对低灵敏度标准化分析的样品。然而,我们的研究结果强调,在解释采用不同冷冻保存方法的样品的组学数据时,需要谨慎,因为即使使用不同类型的容器,也会产生细微的变化。
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引用次数: 0
Honoring Dr. Eng Chon Boon: A Visionary in Biobanking and Cancer Research.
IF 1.6 4区 生物学 Pub Date : 2025-03-10 DOI: 10.1089/bio.2025.0041
Wayne Ng, Robert Hewitt
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引用次数: 0
Medical Biorepositories of South Africa: Establishing a Medical Biorepository Network in South Africa to Advance Health Research. 南非医学生物储存库:在南非建立医学生物储存库网络以推进卫生研究。
IF 1.6 4区 生物学 Pub Date : 2025-03-07 DOI: 10.1089/bio.2024.0160
Engela Helena Conradie, Dominique Elizabeth Anderson, Warren Oswald Fransman, Albe Carina Swanepoel, Mandile Samantha Thobela, Ciara Staunton, Faghri February, Micheline Sanderson, Bonginkosi Mthandeni Duma, Mantombi Rebecca Maseme, Shenuka Singh, Carmen Catherine-Ann Swanepoel

Biobanking is crucial for advancing medical research and personalized medicine, offering high-quality biospecimens for studies on biomarkers, drug development, and diagnostics. Despite its global potential, challenges such as fragmented governance and varying standards hinder biorepository collaboration, particularly in South Africa (SA). A unified national biobank network could enhance research and healthcare by improving biospecimen access, ethical governance, and collaboration. Global biobank networks offer models for standardization, data sharing, and international cooperation. SA can benefit from these models by creating a centralized biobank platform, promoting capacity building, and fostering regional and global partnerships. To address the challenges SA faces regarding biobanking, the Medical Biobanks Cluster established a network named Medical Biorepositories of SA (MBirSA), which seeks to build a cohesive network of medical biorepositories in SA. Through this network, it plans to foster an inclusive culture of biospecimen and data protocol harmonization, while encouraging adherence to legal, ethical, and quality best practices and standards. The network aims to bring stakeholders together, increasing visibility and transparency, and encouraging sector-wide collaboration. MBirSA also aims to offer training to build capacity in global best practices, aid in the development of dependable biorepository infrastructure, and promote research partnerships to enhance healthcare advancements.

生物银行对于推进医学研究和个性化医疗至关重要,它为生物标志物、药物开发和诊断研究提供了高质量的生物标本。尽管生物储存库具有全球潜力,但治理碎片化和标准不一等挑战阻碍了生物储存库的合作,特别是在南非。统一的国家生物库网络可以通过改善生物标本获取、伦理治理和协作来加强研究和医疗保健。全球生物银行网络为标准化、数据共享和国际合作提供了模式。南非可以通过创建一个集中的生物银行平台、促进能力建设以及促进区域和全球伙伴关系,从这些模式中受益。为了解决南非在生物库方面面临的挑战,医学生物库集群建立了一个名为南非医学生物库(MBirSA)的网络,旨在建立一个有凝聚力的南非医学生物库网络。通过这一网络,世卫组织计划培育一种生物标本和数据协议统一的包容性文化,同时鼓励遵守法律、道德和质量最佳做法和标准。该网络旨在将利益攸关方聚集在一起,提高可见度和透明度,并鼓励全部门合作。MBirSA还旨在提供培训,以建立全球最佳实践的能力,帮助开发可靠的生物储存库基础设施,并促进研究伙伴关系,以提高医疗保健的进步。
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引用次数: 0
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