Early Therapeutic Antibody Development: Addressing the Challenges to Expedite a CMC Program

The FDA recently approved the 100th monoclonal antibody (mAb) product for commercial use. In the 35 years since the first approval, monoclonal antibody therapies have become main-stream and their production is considered as a routine, platform process. However, a high proportion of candidate therapeutic antibody drugs fail to come through early development and Chemistry, Manufacturing and Control (CMC) without challenges. Despite the obvious similarities between mAbs and the application of novel discovery and engineering techniques, each product is essentially unique with considerable variability of primary amino acid sequences and post translational modifications (PTMs) contributing to significant differences in physiochemical and biological properties.