(326a) Evaluation of IEX Resins for Purification of a Fc-Fusion Protein

Fc-fusion proteins can have unique properties compared to typical monoclonal antibodies; hence, platform purification strategies may not work. Fc-fusion proteins, while amenable to affinity purification on Protein A, require additional product specific process development for impurity removal as well as reduction of product related substances. In addition such molecules with lower pI can pose additional challenges in terms of effective DNA clearance. Systematic approaches for defining and optimizing ion exchange chromatography steps, including evaluation of different resin types and buffer systems will be presented. Impurity clearance assessment of the entire process will be presented.