Tumorigenicity

In recent years, based on the rapid development of the field of cell regenerative medicine, more and more cell therapy products (CTPs) have entered into the clinic, and the applicable clinical indications have become more and more extensive. Currently, cell therapy products are mostly stem cell products derived from human embryonic stem cells (hESCs), human induced pluripotent stem cells (hiPSCs), and immune cell therapy products from somatic cells. Given the complexity of the process and heterogeneity of CTPs products, the challenges of regulatory strategies and safety evaluation of the products are in the spotlight, thus providing insights into the relevance of CTPs to tumor formation is particularly important.

Cell therapy products have potential risks of tumor formation, i.e., tumorigenicity, oncogenicity and tumor-promoting properties, and the degree of risk is becoming more and more important with the development of industrialized application of cell therapy products for transformation. Currently, CIR Biopharma is able to provide customers with tumorigenicity testing services. Tumorigenicity: refers to the ability of the inoculated cells to form tumors at the injection site and/or at the metastatic site after cell inoculation in animals. At present, the more widely used tumorigenicity test methods include in vivo animal inoculation test and in vitro soft agar clone formation test.