Issue Slow guideline development, patient tissue rules and missing organoid libraries constrain animal-alternative testing

Summary

Even as acceptance of non-animal methods advances, KISTEP warns that turning it into concrete guidelines across regulatory agencies may take considerable time. Using patient tissues and cells in research and commercial platforms requires compliance with genetic information protection rules and with regulations on collecting, storing and moving tissue. Technically, there is still no capability to build large, quality-controlled libraries of patient organoids that preserve each patient's genetic characteristics. Securing a steady and consistent supply of patient cells calls for joint development among large hospitals, industry and academia and for standardised libraries. Platforms that combine organoid and chip data with real clinical data, and explainable AI that meets the expectations of regulators and industry, are also lacking.