Somiari Stella B, Somiari Richard I
Windber Research Institute, Windber, PA, USA.
ITSI - Biosciences, LLC, Johnstown, PA, USA.
Adv Exp Med Biol. 2015;864:11-27. doi: 10.1007/978-3-319-20579-3_2.
Biobanking of human biological specimens has evolved from the simple private collection of often poorly annotated residual clinical specimens, to well annotated and organized collections setup by commercial and not-for-profit organizations. The activities of biobanks is now the focus of international and government agencies in recognition of the need to adopt best practices and provide scientific, ethical and legal guidelines for the industry. The demand for more, high quality and clinically annotated biospecimens will increase, primarily due to the unprecedented level of genomic, post genomic and personalized medicine research activities going on. Demand for more biospecimens provides new challenges and opportunities for developing strategies to build biobanking into a business that is better able to supply the biospecimen needs of the future. A paradigm shift is required particularly in organization and funding, as well as in how and where biospecimens are collected, stored and distributed. New collection sites, organized as Research Ready Hospitals (RRHs) and new public-private partnership models are needed for sustainability and increased biospecimen availability. Biobanks will need to adopt industry-wide standard operating procedures, better and "non-destructive" methods for quality assessment, less expensive methods for sample storage/distribution, and objective methods to manage scarce biospecimens. Ultimately, the success of future biobanks will rely greatly on the success of public-private partnerships, number and diversity of available biospecimens, cost management and the realization that an effective biobank is one that provides high quality and affordable biospecimens to drive research that leads to better health and quality of life for all.
人类生物样本库已从简单地私下收集注释往往不完善的剩余临床样本，发展到由商业组织和非营利组织建立的注释完善且组织有序的样本库。生物样本库的活动如今已成为国际机构和政府机构关注的焦点，因为人们认识到需要采用最佳实践，并为该行业提供科学、伦理和法律准则。对更多高质量且带有临床注释的生物样本的需求将会增加，这主要是由于正在进行的基因组学、后基因组学和个性化医学研究活动达到了前所未有的水平。对更多生物样本的需求为制定相关策略带来了新的挑战与机遇，这些策略旨在将生物样本库发展成为一个更有能力满足未来生物样本需求的业务领域。尤其在组织架构、资金投入以及生物样本的采集、存储和分发方式及地点方面，需要进行范式转变。为了实现可持续发展并增加生物样本的可获取性，需要建立作为“研究就绪医院”（RRHs）的新采集点以及新的公私合作模式。生物样本库将需要采用全行业的标准操作程序、更好且“无损”的质量评估方法、成本更低的样本存储/分发方法，以及管理稀缺生物样本的客观方法。最终，未来生物样本库的成功将在很大程度上依赖于公私合作的成功、可用生物样本的数量和多样性、成本管理，以及认识到一个有效的生物样本库是能够提供高质量且价格合理的生物样本以推动研究，从而为所有人带来更健康的身体和更高生活质量的样本库。
