Biopharmaceutical Informatics: A Strategic Vision for Discovering Developable Biotherapeutic Drug Candidates

Biotherapeutics are rapidly emerging as a successful class of pharmaceuticals, even though significant challenges to their discovery and development remain. In this book chapter, we establish a conceptual framework for potential computational interventions at every stage of biologic drug discovery and early development. We call this framework biopharmaceutical informatics. This chapter provides a comprehensive overview of our strategic vision. This vision calls for closer collaboration between drug discovery and development functions of biopharmaceutical industry by integrating the considerations of developability during early stages of drug discovery. Computational tools already available to enable biopharmaceutical informatics are reviewed in this work. While our focus is on monoclonal antibody-based biologics, the concepts discussed in this work are also applicable to novel formats such as multispecific biologics.