ISO/WD 25430-3

Проект данного международного стандарта был подготовлен рабочей группой.

Тезис

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), to ensure their consistency and reliability in research and non-clinical in vitro applications.

It provides standardized guidelines for evaluating critical quality attributes (CQAs), including structural fidelity, functional relevance, genetic stability, and reproducibility.

This document aims to support the use of hIOs in drug screening, disease modeling, and non-clinical research applications by providing a comprehensive framework for assessing their quality and suitability for various life science purposes.

This document does not include tissue-derived organoids from pathological tissues (e.g., tumor-derived organoids) due to inherent variability.

This document does not apply to hIOs intended for in vivo human application, clinical use, diagnostic use, or therapeutic purposes, as these applications require additional regulatory considerations beyond the scope defined here.