Novel strategies for the purification of monoclonal antibodies

Abstract

Following the success of therapeutic recombinant proteins, monoclonal antibodies (mAbs) represent the second outbreak of innovation created by the biotechnology industry. With more than 25 products in clinical use worldwide, including eight blockbuster drugs, mAbs remain one of the most exciting and promising areas within the world pharmaceutical market, with a global share worth $55 billion in 2010. The greatest capacity constraints in current manufacturing platforms are no longer found in the upstream production processes, where cell culture productivity has dramatically increased over the past decade, but in the downstream purification area. Challenges in the purification of mAbs include reducing production costs, developing robust purification processes and integrating upstream and downstream processes. Although packed-bed chromatography is the workhorse in the downstream processing of therapeutic mAbs, limitations are observed at the very large-scale and therefore additional options are needed to increase the manufacturing capacity and decrease the cost of goods.