[Producing several hundred of kilograms of monoclonal antibodies for therapy: a constant challenge]

Discovering and designing novel therapeutic monoclonal antibodies (mAb) is just the beginning. In order to support clinical evaluations and to reach the market place, rapid and cost effective production platforms are needed. Process development and production efficiency play a crucial role in this space since they influence the cost of good and ultimately wide access to these life-saving medications. Due to their therapeutic dosages and repeated uses, the yearly need for certain mAb, especially those used in the treatments of cancer and inflammation, amounts to several hundred of kilograms. Consequently, significant technological investments are needed to support these extraordinary large needs for such complex proteins, and the industry is constantly aiming at reducing production costs while maintaining product quality to high levels. This review discusses some of the critical scientific and engineering decisions, which span from the selection of cell-line expression platforms to choices of technologies, which influence mAbs cost of goods that need to be made along the development path of a therapeutic mAb.