标准编号：ISO/TS 20399-1:2018
中文名称：生物技术 细胞治疗产品生产中的辅助材料 第1部分：一般要求
英文名称：Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
发布日期：2018-11
标准范围
This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.
This document 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 does not cover the selection, assessment or control of starting materials and excipients.
NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.
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