Description
After the identification of a potential protein drug, the next critical step is the production of sufficient authentic material for testing, characterization, and clinical trials, which, when successful, leads to the need for robust methodologies for large-scale production, purification, characterization, viral inactivation, and continued testing of the final protein product. Building on the valuable first edition, Therapeutic Proteins: Methods and Protocols, Second Edition aims to cover each of these key aspects of protein drug production through the contributions of authors from highly esteemed industrial and academic institutions around the world. Emphasizing the newest developments in the field, this second edition also includes additional emphasis on discovery, including new display and screening methods as well as the design and engineering of new types of therapeutic proteins. There is also discussion of computational and bioinformatics methods, and chapters on safety aspects of therapeutic protein development. Written in the highly successful Methods in Molecular Biology(TM) format, protocol chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Fully updated and practical, Therapeutic Proteins: Methods and Protocols, Second Edition provides an essential resource to all scientists working in the field of therapeutic proteins. 1. Therapeutic Proteins Dimiter S. Dimitrov 2. Synthetic Antibody Libraries Bryce Nelson and Sachdev S. Sidhu 3. The Construction of ‘Phylomer’ Peptide Libraries as a Rich Source of Potent Inhibitors of Protein/Protein Interactions Nadia Milech and Paul Watt 4. Ribosome Display and Screening for Protein Therapeutics Damjana Kastelic and Mingyue He 5. Yeast Display of Engineered Antibody Domains Qi Zhao, Zhongyu Zhu, and Dimiter S. Dimitrov 6. Design, Expression, Purification, and Characterization of Engineered Antibody CH2 and VH Domains Rui Gong, Weizao Chen, and Dimiter S. Dimitrov 7. Engineering of Affibody Molecules for Therapy and Diagnostics Joachim Feldwisch and Vladimir Tolmachev 8. Protein Design for Diversity of Sequences and Conformations Using Dead-End Elimination Karl J.M. Hanf 9. Design and Generation of DVD-IgTM Molecules for Dual-Specific Targeting Enrico DiGiammarino, Tariq Ghayur, and Junjian Liu 10. Engineering and Expression of Bibody and Tribody Constructs in Mammalian Cells and in the Yeast Pichia pastoris Steve Schoonooghe 11. Use of E. coli for the Production of a Single Protein Lili Mao and Masayori Inouye 12. Folding Engineering Strategies for Efficient Membrane Protein Production in E. coli Brent L. Nannenga and Franois Baneyx 13. Transient Expression Technologies: Past, Present, and Future Sabine Geisse and Bernd Voedisch 14. Stable Transfection Pools for Large Quantity of Protein Production Jianxin Ye 15. Mammalian Stable Expression of Biotherapeutics Thomas Jostock and Hans-Peter Knopf 16. Transgenic Expression of Therapeutic Proteins in Arabidopsis thaliana Seed Cory L. Nykiforuk and Joseph G. Boothe 17. Methods for Chromatographic Removal of Endotoxin Adam J. Lowe, Cameron L. Bardliving, and Carl A. Batt 18. Effectiveness of Various Processing Steps for Viral Clearance of Therapeutic Proteins: Database Analyses of Commonly-Used Steps Dana Cipriano, Michael Burnham, and Joseph V. Hughes 19. High-Throughput Quantitative N-Glycan Analysis of Glycoproteins Margaret Doherty, Ciara A. McManus, Rebecca Duke, and Pauline M. Rudd 20. High-Throughput Multimodal Strong Anion Exchange Purification and N-Glycan Characterization of Endogenous Glycoprotein Expressed in Glycoengineered Pichia pastoris Sujatha Gomathinayagam, Erik Hoyt, Alissa M. Thompson, Eric Brown, Khanita Karaveg, Stephen Hamilton, and Huijuan Li 21. Databases and Tools in Glycobiology Natalia V. Artemenko, Andrew G. McDonald, Gavin P. Davey, and Pauline M. Rudd 22. Characterization of PEGylated Biopharmaceutical Products by LC/MS and LC/MS/MS Lihua Huang and P. Clayton Gough 23. Identification of Asp Isomerization in Proteins by 18O Labeling and Tandem Mass Spectrometry Jennifer Zhang and Viswanatham Katta 24. Monitoring of Subvisible Particles in Therapeutic Proteins Satish K. Singh and Maria R. Toler 25. Size-Exclusion Chromatography with Multi-Angle Light Scattering (SEC-MALS) for Elucidating Protein Aggregation Mechanisms Erinc Sahin and Christopher J. Roberts 26. Computational Methods to Predict Therapeutic Protein Aggregation Patrick M. Buck, Sandeep Kumar, Xiaoling Wang, Neeraj J. Agrawal, Bernhardt L. Trout, and Satish K. Singh 27. Coarse-Grained Simulations of Protein Aggregation Troy Cellmer and Nicolas L. Fawzi 28. Chitosan-Based Nanoparticles as Delivery Systems of Therapeutic Proteins Pedro Fonte, Jos Carlos Andrade, Vtor Seabra, and Bruno Sarmento 29. Challenges in the Development and Manufacturing of Antibody-Drug Conjugates Laurent Ducry Lihua Huang and P. Clayton Gough
