Biopharmaceutical Proteins: Opportunities and Challenges John R. Birch and Yemi Onakunle Expression of Antibody Fragments by Periplasmic Secretion in Escherichia coli Andrew G. Popplewell, Mukesh Sehdev, Mariangela Spitali, and A. Neil C. Weir Secretory Production of Therapeutic Proteins in Escherichia coli Sang Yup Lee, Jong Hyun Choi, and Sang Jun Lee Expression of Recombinant LTB Protein in Marine Vibrio VSP60 Wang Yili and Si Lusheng Heterologous Gene Expression in Yeast Lee J. Byrne, Kenneth J. O'Callaghan, and Mick F. Tuite Pharmaceutical Proteins from Methylotrophic Yeasts Eric C. de Bruin, Erwin H. Duitman, Arjo L. de Boer, Marten Veenhuis, Ineke G. A. Bos, and C. Erik Hack Expression of Human Papillomavirus Type 16 L1 in Baculovirus Expression Systems: A Case Study Zheng Jin, Si Lusheng, and Wang Yili Large-Scale Transient Expression of Therapeutic Proteins in Mammalian Cells Sabine Geisse, Martin Jordan, and Florian M. Wurm Site-Specific Integration for High-Level Protein Production in Mammalian Cells Bhaskar Thyagarajan and Michele P. Calos Production of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension Culture Lily Chu, Ilse Blumentals, and Gargi Maheshwari Transgene Control Engineering in Mammalian Cells Beat P. Kramer and Martin Fussenegger Fusion to Albumin as a Means to Slow the Clearance of Small Therapeutic Proteins Using the Pichia pastoris Expression System: A Case Study William P. Sheffield, Teresa R. McCurdy, and Varsha Bhakta High Throughput Recovery of Therapeutic Proteins from the Inclusion Bodies of Escherichia coli: An Overview Amulya K. Panda Isolation, Solubilization, Refolding, and Chromatographic Inclusion Bodies of Escherichia coli cells: A Case Study Surinder M. Singh, A. N. S. Eshwari, Lalit C. Garg, and Amulya K. Panda Large-Scale Preparation of Factor VIIa from Human Plasma: A Case Study Teruhisa Nakashima and Kazuhiko Tomokiyo Purification of Clinical-Grade Monoclonal Antibodies by Chromatographic Methods Alberto L. Horenstein, Ilaria Durelli, and Fabio Malavasi Virus Elimination and Validation Nicola Boschetti and Anna Johnston Virus Removal by Nanofiltration Marina Korneyeva and Scott Rosenthal Determining Residual Host Cell Antigen Levels in Purified Recombinant Proteins by Slot Blot and Scanning Laser Densitometry Aaron P. Miles, Daming Zhu, and Allan Saul Principles of Biopharmaceutical Protein Formulation: An Overview Scott P. Sellers and Yuh-Fun Maa Solid-State Protein Formulation: Methodologies, Stability, and Excipient Effects Yuh-Fun Maa and Scott P. Sellers Stabilization of Therapeutic Proteins by Chemical and Physical Methods Ken-ichi Izutsu Extraction and Characterization of Vaccine Antigens from Water-In-Oil Adjuvant Formulations Aaron P. Miles and Allan Saul Probing Reversible Self-Association of Therapeutic Proteins by Sedimentation Velocity in the Analytical Ultracentrifuge Bernardo Perez-Ramirez and John J. Steckert Biological Characterization of Pegylated Interferons: A Case Study Lei Xie, Constance Cullen, Sheri Bradshaw, Marc DeLorenzo, and Michael J. Grace Characterization of Interferon a2B Pegylated Via Carboxyalkylation: A Case Study David C. Wylie, Marcio Voloch, Seoju Lee, Yan-Hui Liu, Collette Cutler, Brittany Larkin, and Susan Cannon-Carlson Quantifying Recombinant Proteins and Their Degradation Products Using SDS-PAGE and Scanning Laser Densitometry Aaron P. Miles and Allan Saul Extraction and Denaturing Gel Electrophoretic Methodology for the Analysis of Yeast Proteins Kenneth J. O'Callaghan, Lee J. Byrne, and Mick F