生产和监测源自人类间充质干细胞的细胞外囊泡/外泌体质量的协会和企业标准

Qilong Cao , Rui Zhang , Association & Enterprise Standard Drafting Committee, Qingsong Ye
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摘要

本文件依据 GB/T 1.1-2020《标准化工作导则 第 1 部分:标准化文件的结构和起草规则》起草,规定了来源于人间质干细胞 的细胞外囊泡(EVs)/外泌体的鉴别方法、检验规则、标签、包装、贮存、运输和废弃物 处理要求。请注意,本文某些内容可能涉及专利,本文发布机构不承担专利鉴定责任。本文由青岛海尔生物技术有限公司牵头,联合其他 80 家生物技术公司共同完成。本文件由青岛海尔生物技术有限公司牵头,联合中国其他 80 家生物公司、机构和医院共同完成。本文件由 122 位干细胞领域专家共同撰写,并由中国食品药品质量安全促进会正式发布。本文件当前版本的发布已获得组长单位青岛海尔生物技术有限公司的批准。
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Association and enterprise standard for producing and monitoring of quality extracellular vesicles /exosomes derived from human mesenchymal stem cells
This document is drafted in accordance with GB/T 1.1–2020 "Standardization work guidelines Part 1: Structure and drafting rules for standardization documents" to specify the identification methods, inspection rules, label, package,storage, transportation and waste disposal requirement of extracellular vesicles (EVs)/exosomes derived from human mesenchymal stem cells. Please note that certain contents of this document may refer to patents, and the issuing institution of this document does not assume responsibility for identifying patents. This document is led by Qingdao Haier Biotechnology Co. Ltd. in collaboration with other 80 biological companies, institutions and hospitals in China. This document is collectively contributed by 122 experts in stem cell field, and officially released by China Food and Drug Corporation Quality and Safety Promotion Association. Publication of this document in current version has been approved by the group leader Qingdao Haier Biotechnology Co, Ltd.
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