Cell Bank Characterisation

Cell bank characterisation is a critical component of the safety and control of biological and biotechnological products. BioOutsource has extensive experience in the characterisation of cell banks used in the production of biologic drugs and vaccines. We offer a broad range of services to characterise 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 characterisation across the following cell banks:

BioOutsource also perform testing on:

All our cell bank characterization services are conducted to GMP 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.