ISO/TS 20399-3:2018 生物技术 细胞治疗产品生产过程中的辅助材料 第3部分：辅助材料使用者的最佳实践指南

标准编号：ISO/TS 20399-3:2018

中文名称：生物技术 细胞治疗产品生产过程中的辅助材料 第3部分：辅助材料使用者的最佳实践指南

英文名称：Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 3: Best practice guidance for ancillary material users

发布日期：2018-11

标准范围

This document provides guidance for ancillary material (AM) users. It is applicable to cellular 
therapeutic products, including those gene therapy products whereby cells form part of the final 
product. It does not apply to products without cells.
This document focuses primarily on ancillary materials (AMs) of biological (human and animal) origin 
and their potential impurities and contaminants. 
NOTE 1 The decision chart in Figure 1 illustrates the rationale underlying the scope of this document.
However, diverse biological sources, including plants, insects and marine organisms, can also be used 
in the development of a cellular therapeutic product. Therefore the fundamental principles of risk 
management also apply for these sources of AMs.
This document does not cover the selection, assessment or control of starting materials and excipients. 
However, it is anticipated that these are still covered by general risk management procedures.
This document is applicable for users at all stages of clinical development and supply; however 
maximum benefits can be gained by the implementation of the recommendations in the early stages of 
development.
NOTE 2 International, regional or national regulations or requirements can also apply to specific topics 
covered in this document.

标准预览图