标准编号：ISO 23033:2021
中文名称：生物技术 分析方法 细胞治疗产品的试验和特性的一般要求和注意事项
英文名称：Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products
发布日期：2021-08
标准范围
This document provides general requirements for the testing of cellular therapeutic products intended for human use.
This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.
Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.
This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.
This document is not applicable to tissues used in transplantation.
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