ISO/TS 20399-2:2018 生物技术 细胞治疗产品生产中的辅助材料 第2部分：辅助材料供应商的最佳实践指导

标准编号：ISO/TS 20399-2:2018

中文名称：生物技术 细胞治疗产品生产中的辅助材料 第2部分：辅助材料供应商的最佳实践指导

英文名称：Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers

发布日期：2018-11

标准范围

本文件为辅助材料（AM）供应商在标识、纯度、稳定性、生物安全性、性能以及随附文件方面保持高水平的批间一致性提供了指导。本文件适用于细胞治疗产品，包括细胞构成最终产品一部分的基因治疗产品。它不适用于没有电池的产品。本文件中描述的AMs包括生物来源的AMs（例如血清、培养基（包括培养基添加剂）、生长因子和单克隆抗体）和化学来源的AMs。本文件不涉及冷冻保存用二甲基亚砜（DMSO）、微珠、支架、饲养细胞、仪器和仪器，或生物处理后使用的添加剂。本文件不包括起始材料和赋形剂的选择、评估或控制。注:国际、地区或国家法规或要求也可适用于本文件所涵盖的特定主题。

This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation.This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells.The AMs described in this document include those of biological origin [e.g. sera, media (including media additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and instruments, or additives used post bioprocessing.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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