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).