Cell Bank Characterization
Cell bank characterization is a critical component of the safety and control of biological and biotechnological products. BioOutsource has extensive experience in the characterization of cell banks used in the production of biologic drugs and vaccines. We offer a broad range of services to characterize cell banks aligned to the ICH regulatory guidelines – ICH Topic Q 5 D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products.
We perform cell bank characterization across the following cell banks:
BioOutsource also perform testing on:
All our cell bank characterization services are conducted to cGMP standards. Our expert scientists can advise on the most efficient and cost effective testing package to meet regulatory requirements for release into Europe, Japan, Korea and U.S.A.
Contact our experts to discuss your cell bank characterization requirements.