Host: The Japanese Society of Toxicology
Cell therapy products (CTPs) are a new pharmaceutical modality containing living cells. The risk of tumorigenesis derived from cells in the product is one of the major concerns specific to CTPs, and appropriate test methods must be developed as needed. A variety of highly sensitive detection methods for tumorigenic cells as impurities of CTPs have been developed in Japan, some of which have been validated through a public-private joint research (MEASURE). The need for global consensus on the tumorigenicity assessment of CTPs is also discussed at an international consortium (HESI CT-TRACS).
