Introduction

Abstract

Monoclonal antibodies (MAbs) are one of the fastest growing classes of all pharmaceutical products. In 2007, a total of 26 therapeutic MAbs were approved in the U.S. market (Table 1-1), which was valued at more than $12,612 million (Frost & Sullivan 2008). Currently, more than 200 MAbs are in clinical study with more than 600 in preclinical development (Reuters 2008). They play a major role in treating a wide variety of diseases including cancer, infectious disease, allergy, autoimmune disease and inflammation. MAbs now belong to a well-established drug class, that has a high success rate from first in human studies to regulatory approval: Typically 25% (Reichert et al. 2005), which compares favorably with the 11% success rate for small molecule drugs (Kola and Landis 2004).