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.

As an established leader in the field of cell science, Creative Bioarray's expertise in cell banking is unparalleled. Our QC testing plans meet requirements for cell bank release and are designed to meet regulations with assays validated to GMP standards. Ready-to-use testing schemes may be added to existing strategies or customized for the needs of specific programs.

Mammalian Cell Bank Characterization

• Mammalian cells are routinely used in the biopharmaceutical industry. Cell banking to ensure the preservation of these cells at low temperatures for an extended period is at the core of establishing a manufacturing process utilizing these cells and various strategies have evolved to ensure the recovery of viable and functional cells.
• Creative Bioarray now provides comprehensive services for mammalian cell bank characterization according to the biological properties of the cells, their cultivation history, and available testing procedures, including identification, genetic stability, purity, viability, tumorigenicity testing, etc.