An Overview of the Discovery and Development Process for Biologics

This chapter will focus on protein-based biologics, particularly mAbs as they represent the largest class of biologic drugs. By the end of 2011, the US Food and Drug Administration (FDA) had approved close to 40 mAbs and antibody variants. We will provide an overview of the discovery and development process for protein therapeutics with a primary focus on mAbs.Additionally, we will summarize the current status of the protein-based biologics field and discuss several future trends. Keywords: protein-based biologics; mAbs; protein therapeutics; monoclonal antibodies; biotherapeutics; biopharmaceuticals