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.