The characterization of cell banks is essential to ensure the quality of cell-derived biopharmaceutical products. Cell banks must be extensively characterized to assess the cell source with regard to its identity and the presence of other cell lines, adventitious and endogenous agents, or molecular contaminants. However, the test design for the characterization of mammalian, microbial and other cell lines is species-specific and can vary depending on the history of the cell line and the type of media components that may be present.
Charles River Biopharmaceutical Services (BPS) can advise you in the design and execution of a complete testing program for your cell line that is customized to meet your exact specifications and is compliant with international regulatory guidelines. All tests required to demonstrate the suitability of the cell line must be compliant with current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) using validated test procedures and be in agreement with international guidelines
Charles River offers the specialized expertise and rigorous biochemical, molecular and virological tests that ensure the identity, purity, stability and safety of your cell banks. Our cell line characterization programs are designed to include testing panels that detect the presence of contaminants and verify cell line identity for master cell banks (MCB), working cell banks (WCB), research cell banks (RCB) and end-of-production cells (EOPC) or cells at the limit of in vitro age (CAL) as designated by the International Conference on Harmonisation (ICH). We offer these assays for the following expression systems:
To check which of our BPS facilities offer cell line characterization services, click here. For additional information, contact us at email@example.com or 1.877.CRIVER.1.
Visit our Regulatory Document Library to access regulatory documents on cell line characterization from the FDA, EMA, MHLW, WHO and more.