Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

A real-world guide to the production and manufacturing of biopharmaceuticalsWhile much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase?appropriate approaches for ensuring product stabilityDevelopment of commercially viable formulations for liquid and lyophilized dosage formsOptimal storage, packaging, and shipping methodsCase studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractionsUseful analysis of successful and failed productsFormulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.Content: Chapter 1 The Structure of Biological Therapeutics (pages 1–40): Sheryl Martin?Moe, Tim Osslund, Y. John Wang, Tahir Mahmood, Rohini Deshpande and Susan HershensonChapter 2 Chemical Instability in Peptide and Protein Pharmaceuticals (pages 41–67): Elizabeth M. Topp, Lei Zhang, Hong Zhao, Robert W. Payne, Gabriel J. Evans and Mark Cornell ManningChapter 3 Physical Stability of Protein Pharmaceuticals (pages 69–104): Byeong S. Chang and Bernice YeungChapter 4 Immunogenicity of Therapeutic Proteins (pages 105–117): Steven J. SwansonChapter 5 Preformulation Research: Assessing Protein Solution Behavior during Early Development (pages 119–146): Bernardo Perez?Ramirez, Nicholas Guziewicz and Robert SimlerChapter 6 Formulation Development of Phase 1–2 Biopharmaceuticals: An Efficient and Timely Approach (pages 147–159): Nicholas W. WarneChapter 7 Late?Stage Formulation Development and Characterization of Biopharmaceuticals (pages 161–171): Adeola O. GrilloChapter 8 An Empirical Phase Diagram–High?Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals (pages 173–205): Sangeeta B. Joshi, Akhilesh Bhambhani, Yuhong Zeng and C. Russell MiddaughChapter 9 Fluorescence and Phosphorescence Methods to Probe Protein Structure and Stability in Ice: The Case of Azurin (pages 207–229): Giovanni B. StrambiniChapter 10 Applications of Sedimentation Velocity Analytical Ultracentrifugation (pages 231–251): Tom LaueChapter 11 Field Flow Fractionation with Multiangle Light Scattering for Measuring Particle Size Distributions of Virus?Like Particles (pages 253–268): Joyce A. Sweeney and Christopher HammChapter 12 Light?Scattering Techniques and their Application to Formulation and Aggregation Concerns (pages 269–305): Michael Larkin and Philip WyattChapter 13 Effective Approaches to Formulation Development of Biopharmaceuticals (pages 307–328): Rajiv Nayar and Mitra MosharrafChapter 14 Prediction of Aggregation Propensity from Primary Sequence Information (pages 329–347): Mark Cornell Manning, Gabriel J. Evans, Cody M. Van Pelt and Robert W. PayneChapter 15 High?Concentration Antibody Formulations (pages 349–381): Steven J. Shire, Jun Liu, Wolfgang Friess, Susanne Jorg and Hanns?Christian MahlerChapter 16 Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins (pages 383–427): Sampathkumar Krishnan, Monica M. Pallitto and Margaret S. RicciChapter 17 Reversible Self?Association of Pharmaceutical Proteins: Characterization and Case Studies (pages 429–455): Vikas K. Sharma, Harminder Bajaj and Devendra S. KaloniaChapter 18 Design of a Formulation for Freeze Drying (pages 457–492): Feroz Jameel and Mike J. PikalChapter 19 Protein Conformation and Reactivity in Amorphous Solids (pages 493–506): Lei Zhang, Sandipan Sinha and Elizabeth M. ToppChapter 20 The Impact of Buffer on Solid?State Properties and Stability of Freeze?Dried Dosage Forms (pages 507–519): Evgenyi Y. Shalaev and Larry A. GatlinChapter 21 Stabilization of Lyophilized Pharmaceuticals by Control of Molecular Mobility: Impact of Thermal History (pages 521–548): Suman Luthra and Michael J. PikalChapter 22 Structural Analysis of Proteins in Dried Matrices (pages 549–563): Andrea Hawe, Sandipan Sinha, Wolfgang Friess and Wim JiskootChapter 23 The Impact of Formulation and Drying Processes on the Characteristics and Performance of Biopharmaceutical Powders (pages 565–585): Vu L. Truong and Ahmad M. Abdul?FattahChapter 24 Manufacturing Fundamentals for Biopharmaceuticals (pages 587–604): Maninder HoraChapter 25 Protein Stability During Bioprocessing (pages 605–624): Mark Cornell Manning, Gabriel J. Evans and Robert W. PayneChapter 26 Freezing and Thawing of Protein Solutions (pages 625–675): Satish K. Singh and Sandeep NemaChapter 27 Strategies for Bulk Storage and Shipment of Proteins (pages 677–704): Feroz Jameel, Chakradhar Padala and Theodore W. RandolphChapter 28 Drying Process Methods for Biopharmaceutical Products: An Overview (pages 705–738): Ahmad M. Abdul?Fattah and Vu L. TruongChapter 29 Spray Drying of Biopharmaceuticals and Vaccines (pages 739–761): Jim Searles and Govindan MohanChapter 30 Development and Optimization of the Freeze?Drying Processes (pages 763–796): Feroz Jameel and Jim SearlesChapter 31 Considerations for Successful Lyophilization Process Scale?Up, Technology Transfer, and Routine Production (pages 797–826): Samir U. Sane and Chung C. HsuChapter 32 Process Robustness in Freeze Drying of Biopharmaceuticals (pages 827–837): D. Q. Wang, D. MacLean and X. MaChapter 33 Filling Processes and Technologies for Liquid Biopharmaceuticals (pages 839–856): Ananth Sethuraman, Xiaogang Pan, Bhavya Mehta and Vinay RadhakrishnanChapter 34 Leachables and Extractables (pages 857–880): Jim Castner, Pedro Benites and Michael BresnickChapter 35 Primary Container and Closure Selection for Biopharmaceuticals (pages 881–896): Olivia HendersonChapter 36 Prefilled Syringes for Biopharmaceuticals (pages 897–916): Robert SwiftChapter 37 Impact of Manufacturing Processes on Drug Product Stability and Quality (pages 917–940): Nitin Rathore, Rahul S. Rajan and Erwin Freund