ISO/TS 23511:2023 生物技术 细胞系鉴定的一般要求和考虑事项

标准编号：ISO/TS 23511:2023

中文名称：生物技术 细胞系鉴定的一般要求和考虑事项

英文名称：Biotechnology — General requirements and considerations for cell line authentication

发布日期：2023-05

标准范围

本文件定义了生物技术领域中与细胞系鉴定相关的术语。它描述了细胞系鉴定的一般原理、检测策略和分析方法。它规定了方法选择、质量控制参数、数据分析和报告的要求和关键考虑因素。本文件适用于基础研究、转化研究和产品制造领域培养和储存中细胞系的常规检查。它也适用于学术和工业实验室、细胞库和生产场所的细胞系来源验证。它主要适用于哺乳动物细胞，包括人细胞。本文件不适用于非动物细胞（例如微生物污染、植物细胞），也不适用于复杂基质中的细胞（例如组织、器官、类器官、植物）。

This document defines terms related to cell line authentication in the field of biotechnology. It describes the general principles, detection strategies and analytical methods for cell line authentication. It specifies requirements and key considerations for method selection, quality control parameters, data analysis and reporting.

This document is applicable to routine inspection of cell lines in culture and in storage in the fields of basic research, translational studies and product manufacturing. It is also applicable to cell line origin validation in academic and industrial laboratories, cell banks and manufacturing sites. It is primarily applicable to mammalian cells, including human cells.

This document does not apply to non-animal cells (e.g. microbial contamination, plant cells), nor to cells in complex matrices (e.g. tissues, organs, organoids, plants).

标准预览图