Samsung Organoids：一个基于GxP的药物筛选平台，利用患者来源肿瘤类器官并附带临床记录和多组学数据

Patient-derived tumor organoids have emerged as a promising translational model for oncology drug development. However, its utility has been limited by restricted access to patient-derived materials and insufficient donor-related data such as clinical records. Here, we report the establishment of the Samsung Organoids, a GxP-based, standardized patient-derived organoid designed to support data-driven cancer drug development. All organoids were generated and processed by GxP-qualified personnel under rigorously controlled and fully documented procedures, ensuring reproducibility, traceability, and regulatory readiness. Each organoid line is linked to clinical information of the corresponding donor and multi-omics data both original tumor tissues and derived organoids. Comparative analyses demonstrated high concordance of mutational profiles and gene expression patterns between tumor tissues and matched organoids, confirming preservation of the patient-specific characteristics. To examine the responsiveness of organoids to various drugs including small molecules and ADCs, we performed high-throughput drug screening combined with high-content imaging. Drug responsiveness data revealed substantial inter-patient heterogeneity, enabling classification of organoids into distinct groups. Further, we identified particular gene expression signatures by cross-group comparison, demonstrating explanation of different drug sensitivity between organoids. Conclusively, by integrating patient clinical information with genomic/genetic alterations, transcriptomic signatures, and functional drug response data, the Samsung Organoids provides translational insights into determinants of therapeutic sensitivity and resistance, helping successful cancer drug development such as drug candidate selection, biomarker discovery, and preclinical decision-making.