[Validation and characterization of chromatographic sorbent for protein purification]

The purification of biomolecules for human therapeutic use by liquid chromatography have been widely extended since 10 years. The preparation of such molecules have to be in accordance with quality requirements and some of them still have to be defined because of their high specificity. As a consequence, each purification step must be validated to guarantee a constant product quality and the absence of any contaminant issued from the solid phases employed. In this context, we developed several techniques allowing the characterization of sorbents and their eventual degradation products in order to determine the level of toxicity of the potential leachables in relation with their mode of use. This procedure could be generalized in the future according to the constraints due to the fractionation process itself.