Ion Exchange Chromatographic Methods for Purification of Therapeutic Antibodies.

Ion Exchange Chromatography has been a critical unit operation for manufacturing of therapeutic antibodies. Cation and anion exchange chromatography are used extensively to remove process-related as well as product-related impurities to obtain the final product. In this chapter, we describe the methods for separating and purifying charge variants and aggregates for manufacturing of monoclonal antibodies. The methods related to removal of host cell impurities such as host cell DNA and host cell proteins are also described. With minimal modifications, the protocols described here can be employed to purify any monoclonal antibody.