生物样本库发展的现状、机遇与挑战

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。

Status,Opportunities and Challenges of Biobanks

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.