ISO/CD 25430-3

A draft is being reviewed by the committee.

Abstract

This document specifies the quality assessment criteria and methods for human intestinal organoids (hIOs), derived from pluripotent stem cells (PSCs) and tissue-derived stem cells (TSCs).

It addresses quality attributes relevant to intestinal organoid performance in endpoint assays. These include structural fidelity, functional relevance, basic genetic stability and reproducibility.

This document is applicable to hIOs used in drug screening, safety assessment, disease modeling and other non-clinical research applications.

Disease models generated from PSCs, engineered lines or non-pathological donor-derived materials are within the scope of this document, whereas tumour-derived organoids and organoids directly derived from pathological tissues are excluded.

This document does not apply to hIOs intended for in vivo human application, clinical use, or therapeutic purposes.