标准摘要
[中文适用范围]： 本文件提供了用于人类使用的细胞治疗产品测试的一般要求。 本文件还提供了细胞治疗产品表征的考虑因素，包括选择和设计适合目的的分析方法的方法。 这些考虑因素可用于建立细胞治疗产品的关键质量属性。 本文件适用于细胞起始材料（包括组织工程产品的起始材料）和细胞治疗产品的中间体。 本文件不适用于移植中使用的组织。 [外文原描述]： 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.
英文名称Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products