ABSTRACT
Monoclonal antibodies and Fc-fusion proteins form the largest and most rapidly expanding category of biopharmaceuticals today with annual sales exceeding $8 billion and applications across a wide range of diseases [1]. With the growth of this class of biomolecules, significant attention is now being focused on reducing manufacturing costs and streamlining process development activities to enable the rapid progression of these therapeutic candidates through clinical development. Protein A affinity chromatography has come to be used as the industry-wide standard for capture and purification of antibodies and Fc-fusion proteins. This chapter will provide a brief introduction to antibodies and Fcfusion proteins, describe the basics of Protein A chromatography and discuss practical considerations for the development of this process step in an industrial context.
