Development of Antibody Therapeutics : Engineering, Characterization, and Safety Assessment

Including case studies of FDA-approved drugs, this book covers the processes and technologies in every step of antibody therapeutics development - history and background, process development, preclinical toxicology, manufacture, and regulations. It addresses cutting-edge topics like cell line generation, fermentation, antibody purification, product characterization, and preclinical and clinical evaluation. Detailing all pharmaceutical aspects of antibody engineering and production, it serves as a "user's manual" reference for the industry.