Host: The Japanese Society of Toxicology
In the aspect of nonclinical safety assessment for human cell therapy products, assessment of general toxicity and tumorgenicity, risk assessment of non-cell components and impurities are required to support clinical trials. In the case of genetically modified cell therapy products or cell products using genome-editing technology, sponsors can refer to “Ensuring the Quality and Safety of Gene Therapy Products” (PSEHB/MDED Notification No.0709-2) and the report of gene therapy products using current genome-editing technology by the science board of PMDA (Human Gene Therapy 2020; 31: 1043-53). In this presentation, our nonclinical considerations for cell therapy products will be provided.
