ISO/CD TS 23511.2

Biotechnology — General requirements and considerations for cell line authentication

Scope

This document defines terms related to cell line authentication in the field of biotechnology. This document describes the general principles, detection strategies and analytical methods for cell line authentication. This document provides requirements and 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 field of basic research, translational studies and product manufacturing.
This document is also applicable to cell line origin validation in academic and industrial laboratories, cell banks and manufacturing sites. This document is intended for mammalian cells, including human cells.
This document is not intended for non-animal cells (e.g. microbial contamination, plant cells), nor for cells in complex matrix (e.g. tissues, organs, organoids, plants).