ISO/WD 26125-1

Biotechnology — Tumorigenicity testing — Part 1: General requirements and considerations for testing of cellular therapeutic products

Scope

This document specifies definitions and general requirements for tumorigenic cell detection and tumorigenicity testing. This document provides a general approach for designing fit-for-purpose tests to identify transformed cells and undifferentiated pluripotent stem cells (PSCs) in human cellular therapeutic products. This document also provides general requirements and considerations for the evaluation of tumorigenicity of cellular therapeutic products.
This document is intended for characterization and testing of human cellular therapeutic products and ex vivo gene therapy products with respect to their tumorigenicity. This document is applicable to human cellular therapeutic products including human PSC-derived cellular therapeutic products and genetically-modified cellular therapeutic products.
This document does not specify at which stage of the development phase the test methods are used. This document is not applicable to human biological organs and tissues for transplantation.
NOTE          Other relevant international or national guidelines can also be referred in addition to this document.