ISO 23511:2026

Biotechnology — General requirements and considerations for cell line identification and cross-contamination testing

Scope

This document specifies general principles, detection strategies and analytical methods for cell line identification of mammalian cells in the field of biotechnology. This document also specifies general requirements and key considerations for method selection, quality control parameters, data analysis and reporting in cell line identification.
This document is applicable to routine cell line cross-contamination testing in the fields of basic research, translational medicine studies and cell therapeutic product manufacturing. This document is also applicable to cell line identity confirmation to prevent cell misidentification in academic and industrial laboratories, cell banks and manufacturing sites. This document is primarily applicable to mammalian cells.