郜恒骏;杜莉利;张小燕;张可浩;叶扬;
GAO Heng-jun;DU Li-li;ZHANG Xiao-yan;ZHANG Ke-hao;YE Yang;National Engineering Center for Biochip at Shanghai;Shanghai ZhangJiang Biobank;

• 1:生物芯片上海国家工程研究中心
• 2:上海张江生物银行

摘要(Abstract)：

生物样本库是实现转化医学与精准医学的重要源头与关键环节之一,随着精准医学计划和"健康中国2030"战略规划的提出,生物样本库迎来了难得的发展机遇。同时我国生物样本库存在的问题也日益凸显,包括相关国家标准尚未出台、标准化流程实施与质量控制有待推进、共享应用机制尚待完善、低层次重复建设较为严重、自身造血能力普遍较弱及可持续发展机制有待探索等。在过去十年,生物样本库在标准化、共享应用、集约化和可持续发展等方面取得了一定发展,促进了生物样本资源在生物医药产业链各环节的充分应用,开启了中国生物样本库标准化建设的新时代。
A biobank is one of the important sources and key links in the realization of translational medicine and precision medicine. The initiation of "Precision Medicine"and "Healthy China 2030"Plan has created an extremely rare opportunity for the development of biobanks. At the same time,it also highlights the problems existing in the biobanks in China,including relevant national standards have not yet been published,implementation of standardized processes and quality control need to be pushed forward,sharing-application mechanism needs to be improved,low-level redundant construction is more serious,self-restoration ability is generally weak,a sustainable development mechanism needs to be explored,and so on. In the past ten years,a lot of pioneering work on the standardization,sharing applications,intensification and sustainable development of biobanks has been done to promote the full application of bio-specimens in biopharmaceutical industry. We have initiated a new era of constructing the standardization of biobanks in China.

关键词(KeyWords)： 生物样本库;标准化;共享应用;集约化;可持续发展
biobank;standardization;shared application;intensification;sustainable development

Abstract:

Keywords:

基金项目(Foundation): 上海张江生物银行(2016-07);; 国家人类遗传资源共享服务平台(2005DKA21300)

作者(Authors): 郜恒骏;杜莉利;张小燕;张可浩;叶扬;
GAO Heng-jun;DU Li-li;ZHANG Xiao-yan;ZHANG Ke-hao;YE Yang;National Engineering Center for Biochip at Shanghai;Shanghai ZhangJiang Biobank;

参考文献(References)：

• [1]VégvAri,Welinder C,Lindberg H,et al.Biobank resources for future patient care:developments,principles and concepts[J].J Clin Bioinforma,2011,1:24-35.
• [2]史晓红,郭健.国际生物样本库的发展现状[J].中华临床实验室管理电子杂志,2017,5:19-23.
• [3]Holub P,Swertz M,Reihs R,et a1.BBMRI-ERIC directory:515 biobanks with over 60 million biological samples[J].Biopreserv Biobank,2016,14:559-562.
• [4]UK Biobank[EB/OL].http://www.ukbiobank.ac.uk/resources/.
• [5]Leaf C.Why we're losing the war on cancer(and how to win it)[J].Fortune,2004,149:76-82.
• [6]International Cancer Genome Consortium,Hudson TJ,Anderson W,et al.International network of cancer genome projects[J].Nature,2010,464:993-998.
• [7]Collins FS,Varmus H.A new initiative on precision medicine[J].N Engl J Med,2015,372:793-795.
• [8]刘旭.中国将启动精准医疗计划2030年前投入600亿元[J].上海医药,2015,36:80.
• [9]杜莉利.生物样本库的标准化建设[J].转化医学杂志,2016,5:324-326.
• [10]郭丹,杨文航,徐英春.临床生物样本库信息系统建设与发展[J].协和医学杂志,2018,9:81-86.
• [11]Rossi E,Rosa M,Rossi L,et al.Web Bio Bank:A new platform for integrating clinical forms and shared neurosignal analyses to support multi-centre studies in Parkinson's Disease[J].J Biomed Inform,2014,52:92-104.
• [12]Mills FJ,Brooks A.Information systems for biobanks/biorepositories:handling information associated with compliant sample management[J].Biopreserv Biobank,2010,8:163-165.
• [13]Hewitt RE.Biobanking:the foundation of personalized medicine[J].Curr Opin Oncol,2011,23:112-119.
• [14]叶扬,张可浩,郜恒骏.生物银行:集约化生物样本库新模式[J].实用器官移植电子杂志,2017,5:415-416.
• [15]Odeh H,Miranda L,Rao A,et al.The biobank economic modeling tool(BEMT):Online Financial Planning to facilitate biobank sustainability[J].Biopreserv Biobank,2015,13:421-429.