ISO/PWI 23033-2

Biotechnology —– Cell characterization — Part 2: General requirements and considerations for the testing and characterization of human and mammalian-derived cells and cell lines

Scope

This document provides general requirements for the testing and characterization of human and mammalian derived primary cells and cell lines.
This document also provides considerations for the selection and design of analytical methods that are fit for purpose for the cell characterization intended use.
Such considerations can be used cells used in cell-based research, cell-based assays, and cells as starting material for the production of complex cellular systems such as spheroids, organoids and microphysiological systems.
This document is not applicable to cells used in cellular therapeutic products.