Includes bibliographical references and index.

Molecular Biotechnology: From DNA Sequence to Therapeutic Protein / Ronald S. Oosting -- Biophysical and Biochemical Characteristics of Therapeutic Proteins / Wim Jiskoot and Daan J. A. Crommelin -- Protein Stability and Characterization / Atanas Koulov -- Production and Purification of Recombinant Proteins / Alfred Luitjens and Emile van Corven -- Formulation of Biologics Including Biopharmaceutical Considerations / Daan J. A. Crommelin, Andrea Hawe, and Wim Jiskoot -- Pharmacokinetics and Pharmacodynamics of Therapeutic Peptides and Proteins / Bernd Meibohm -- Immunogenicity of Therapeutic Proteins / Wim Jiskoot, Theo Rispens, and Grzegorz Kijanka -- Monoclonal Antibodies: From Structure to Therapeutic Application / Rong Deng, C. Andrew Boswell, Wendy S. Putnam, Meina T. Tang, Amit Garg, Chunze Li, Shan Chung, and Sandhya Girish -- Genomics, Other "OMIC" Technologies, Precision Medicine, and Additional Biotechnology-Related Techniques / Robert D. Sindelar -- Dispensing Biotechnology Products: Handling, Professional Education, and Product Information / Robert D. Sindelar -- Economic Considerations in Medical Biotechnology / Amit S. Patel and Kartick P. Shirur -- Regulatory Framework for Biosimilars / Vinod P. Shah and Daan J. A. Crommelin -- An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications / James P. McCormack -- Vaccines / Wim Jiskoot, Gideon F. A. Kersten, Enrico Mastrobattista, and Bram Slütter -- Oligonucleotides -- Raymond M. Schiffelers, Erik Oude Blenke, and Enrico Mastrobattista -- Gene Therapy / Hao Wu, Amit Kumar Chaudhary, and Ram I. Mahato -- Advanced Therapies: Clinical, Non-clinical and Quality Considerations/ Karin H. Hoogendoorn -- Insulin / John M. Beals, Michael R. DeFelippis, Chad D. Paavola, David P. Allen, Ashish Garg, and D. Bruce Baldwin -- Follicle-Stimulating Hormone / Tom Sam and Renato de Leeuw -- Human Growth Hormone / Le N. Dao, Barbara Lippe, Michael Laird, and Ingrid Beierle -- Recombinant Coagulation Factors and Thrombolytic Agents / Koen Mertens and Alexander B. Meijer -- Recombinant Human Deoxyribonuclease I / Robert A. Lazarus and Jeffrey S. Wagener† -- Monoclonal Antibodies in Cancer / Jürgen Barth -- Hematopoietic Growth Factors / Juan Jose Pérez-Ruixo -- Monoclonal Antibodies in Solid Organ Transplantation / Nicole A. Pilch, Holly B. Meadows, and Rita R. Alloway -- Antibody-Based Biotherapeutics in Inflammatory Diseases / Honghui Zhou, Yan Xu, and Amarnath Sharma -- Interferons and Interleukins / Jean-Charles Ryff and Sidney Pestka†.

English