Enables biopharmaceutical developers and producers to ensure safe products, reduce risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterizing processes, process intermediates, and final products, emphasizing cost effectiveness while determining what levels of validation are required for different phases of development, license application, and process improvements. Sofer is director of regulatory services at BioReliance. Zabriskie is director of biopharmaceutical process sciences at Biogen.