Cell banks are created by controlled rate freezing of pooled cell suspensions. Each line is characterized by freedom from adventitious agents, identity, and biological behavior in immunosuppressed animals. According to current regulations (ICH guideline Q5A), we must consider the following aspects, including the origin and history of the cell line cellular morphology and growth characteristics, cellular identity, purity of the cell lines, tumorigenicity, and oncogenicity, genetic stability, etc. At Creative Bioarray, cell line characterization is performed for master cell banks (MCB), working cell banks (WCB), and end-of-production cells (EPC) or cells at the limit (CAL) of in vitro cell age used for production.
