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Humana Press Therapeutic Proteins Methods And Protocols by C. Mark Smales , David C. James
With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based "drugs" that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.show more Biopharmaceutical Proteins: Opportunities and ChallengesJohn R. Birch and Yemi OnakunleExpression of Antibody Fragments by Periplasmic Secretion in Escherichia coliAndrew G. Popplewell, Mukesh Sehdev, Mariangela Spitali, and A. Neil C. WeirSecretory Production of Therapeutic Proteins in Escherichia coliSang Yup Lee, Jong Hyun Choi, and Sang Jun LeeExpression of Recombinant LTB Protein in Marine Vibrio VSP60Wang Yili and Si LushengHeterologous Gene Expression in YeastLee J. Byrne, Kenneth J. O'Callaghan, and Mick F. TuitePharmaceutical Proteins from Methylotrophic YeastsEric C. de Bruin, Erwin H. Duitman, Arjo L. de Boer, Marten Veenhuis, Ineke G. A. Bos, and C. Erik HackExpression of Human Papillomavirus Type 16 L1 in Baculovirus Expression Systems: A Case StudyZheng Jin, Si Lusheng, and Wang YiliLarge-Scale Transient Expression of Therapeutic Proteins in Mammalian CellsSabine Geisse, Martin Jordan, and Florian M. WurmSite-Specific Integration for High-Level Protein Production in Mammalian CellsBhaskar Thyagarajan and Michele P. CalosProduction of Recombinant Therapeutic Proteins by Mammalian Cells in Suspension CultureLily Chu, Ilse Blumentals, and Gargi MaheshwariTransgene Control Engineering in Mammalian CellsBeat P. Kramer and Martin FusseneggerFusion to Albumin as a Means to Slow the Clearance of Small Therapeutic Proteins Using the Pichia pastoris Expression System: A Case StudyWilliam P. Sheffield, Teresa R. McCurdy, and Varsha BhaktaHigh Throughput Recovery of Therapeutic Proteins from the Inclusion Bodies of Escherichia coli: An OverviewAmulya K. PandaIsolation, Solubilization, Refolding, and Chromatographic Inclusion Bodies of Escherichia coli cells: A Case StudySurinder M. Singh, A. N. S. Eshwari, Lalit C. Garg, and Amulya K. PandaLarge-Scale Preparation of Factor VIIa from Human Plasma: A Case StudyTeruhisa Nakashima and Kazuhiko TomokiyoPurification of Clinical-Grade Monoclonal Antibodies by Chromatographic MethodsAlberto L. Horenstein, Ilaria Durelli, and Fabio MalavasiVirus Elimination and ValidationNicola Boschetti and Anna JohnstonVirus Removal by NanofiltrationMarina Korneyeva and Scott RosenthalDetermining Residual Host Cell Antigen Levels in Purified Recombinant Proteins by Slot Blot and Scanning Laser DensitometryAaron P. Miles, Daming Zhu, and Allan SaulPrinciples of Biopharmaceutical Protein Formulation: An OverviewScott P. Sellers and Yuh-Fun MaaSolid-State Protein Formulation: Methodologies, Stability, and Excipient EffectsYuh-Fun Maa and Scott P. SellersStabilization of Therapeutic Proteins by Chemical and Physical MethodsKen-ichi IzutsuExtraction and Characterization of Vaccine Antigens from Water-In-Oil Adjuvant FormulationsAaron P. Miles and Allan SaulProbing Reversible Self-Association of Therapeutic Proteins by Sedimentation Velocity in the Analytical UltracentrifugeBernardo Perez-Ramirez and John J. SteckertBiological Characterization of Pegylated Interferons: A Case StudyLei Xie, Constance Cullen, Sheri Bradshaw, Marc DeLorenzo, and Michael J. GraceCharacterization of Interferon a2B Pegylated Via Carboxyalkylation: A Case StudyDavid C. Wylie, Marcio Voloch, Seoju Lee, Yan-Hui Liu, Collette Cutler, Brittany Larkin, and Susan Cannon-CarlsonQuantifying Recombinant Proteins and Their Degradation Products Using SDS-PAGE and Scanning Laser DensitometryAaron P. Miles and Allan SaulExtraction and Denaturing Gel Electrophoretic Methodology for the Analysis of Yeast ProteinsKenneth J. O'Callaghan, Lee J. Byrne, and Mick F