Discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent
Introduction: Pharmaceutical Development Chapter 1: Current status of monoclonal antibodies in development Chapter 2: Stability of mAbs Routes of degradation encountered during processing and storage Overview of analytical tools used to characterize and monitor stability Methods to evaluate in vivo stability Chapter 3: Challenges in intravenous (IV) administration Chapter 4: Challenges in subcutaneous (SC) administration Chapter 5: Strategies to deal with these challenges IV strategies SC strategies Chapter 6: Development of delivery device technology to deal with the challenges of highly viscous mAb formulations at high concentration Chapter 7: The molecular basis of high viscosity of mAbs at high concentration Chapter 8: Conclusions The future of mAbs as Therapeutics
Steven J. Shire is currently consulting and serving as an adjunct faculty member of the USC School of Pharmacy and University of Connecticut School of Pharmaceutical Sciences. He was at Genentech for 32 years where the majority of his career was in the pharmaceutical development department. He retired in June 2013 as Staff Scientist in the Late Stage Pharmaceutical Development Department. He has been responsible for directing research and development of formulations for a variety of recombinant human proteins including Pulmozyme (R) and Xolair (R). Dr. Shire has served as the chair of the American Association of Pharmaceutical Scientists (AAPS) Biotechnology Section, and was elected as a Fellow of AAPS in 1998 and member at large to the AAPS Executive Council in 2001. He has published over 80 reviews and papers dealing with various aspects of formulation and pharmaceutical development of therapeutic proteins.