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 intended use of the cells.
This document is applicable to cells used in cell-based research, cell-based assays and biomanufacturing, as well as cells used as starting material for the production of multi-cellular systems such as spheroids, organoids, tissue engineered materials and microphysiological systems.
This document is not applicable to cells used in cellular therapeutic products.