Cells are the key starting raw material for the production of antibodies, protein drugs, and vaccines, as well as the basis for cell therapy and gene therapy. The quality of cells, the stability of their characteristics, and the degree of species difference significantly influence the entire process of research and development, production, and clinical application of biologics. Pharmacopoeia of the People's Republic of China (ChP) has made clear provisions for the testing and quality control of biologics in the main chapters for biologics production management and quality control, requiring comprehensive testing of cell banks. Regulations, such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), also provide guidelines for cell quality testing, which specify that adequate testing for cell bank allows its use in production. Therefore, the cell assay report is an essential material in investigational new drug (IND) applications for biologics research and development and Non-disclosure Agreement (NDA), as well as the mandatory item to be audited for audit departments such as CDE and FDA.

China Center of Industrial Culture Collection (CICC) provides quality testing services for human and mammalian cell seeds, master cell Banks (MCB), working cell banks (WCB), end-of-production cells (EOPC), and unprocessed bulk (UPB). To meet the personalized needs of domestic and foreign customers for product declaration, technical service solutions can be customized in terms of testing parameters, testing methods, data analysis, etc., taking into account different cell types of biological products (e.g., immune cells, stem cells).