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为美好未来铺路的标准化与创新:ISO/TC276/WG2生物样本库和生物资源活动更新

Standardization and Innovation in Paving a Path to a Better Future: An Update of Activities in ISO/TC276/WG2 Biobanks and Bioresources.

作者信息

Furuta Koh, Allocca Clare M, Schacter Brent, Bledsoe Marianna J, Ramirez Nilsa C

机构信息

1 Kanagawa Cancer Center , Yokohama, Japan .

2 Senior Advisor for Standardization, Standards Coordination Office, National Institute of Standards and Technology , Gaithersburg, Maryland.

出版信息

Biopreserv Biobank. 2018 Feb;16(1):23-27. doi: 10.1089/bio.2017.0117. Epub 2018 Feb 2.

DOI:10.1089/bio.2017.0117
PMID:29394084
Abstract

Recent advances in biotechnology are making it possible to advance science and improve healthcare with increasing speed and precision. Biobanking, as a foundation of the biotechnology infrastructure, is critical to the assurance of quality for many of the key components for these advancing technologies in both the human and nonhuman domains. Biobanking must advance to support the increased complexity and required precision needs of biological resources. Standards development can provide an important link for the research and development community by providing tools to ensure quality, fitness-for-purpose, and reproducibility in biobanking. ISBER has been developing the ISBER Best Practices revision. At the same time, ISO/TC276/ WG2 has been developing an International Standard (IS) ISO/DIS 20387 General requirements for biobanking standard. It is important that ISBER and ISO/TC276/WG2 harmonize and/or align their products to enable members of the diverse biobanking community to tailor their own suite of tools to support their specific needs. The availability of both standards and best practices that are complementary will maximize available support for all biobanks. The increased availability of complementary standards, tools, and best practices will facilitate the path to new biotechnology advances and a better future.

摘要

生物技术的最新进展使得以越来越快的速度和精度推动科学发展和改善医疗保健成为可能。生物样本库作为生物技术基础设施的基础,对于确保人类和非人类领域中这些先进技术的许多关键组成部分的质量至关重要。生物样本库必须不断发展,以支持生物资源日益增加的复杂性和所需的精度要求。标准制定可为研发界提供重要联系,通过提供工具来确保生物样本库的质量、适用性和可重复性。国际生物与环境样本库协会(ISBER)一直在制定《ISBER最佳实践》修订版。与此同时,ISO/TC276/WG2一直在制定一项国际标准(IS)ISO/DIS 20387《生物样本库通用要求》标准。ISBER和ISO/TC276/WG2协调和/或调整其产品非常重要,以便使不同生物样本库社区的成员能够定制自己的一套工具,以满足其特定需求。互补的标准和最佳实践的可用性将最大限度地为所有生物样本库提供支持。互补标准、工具和最佳实践的更多可用性将促进通往新生物技术进步和更美好未来的道路。

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