Beschreibung:
A real-world guide to the production and manufacturing of biopharmaceuticals
Introduction ( John Carpenter ). Part I Preformulation and Development of Stability Indicating Assays: Biophysical Characterization Techniques. 1. The Structure of Biological Therapeutics ( Sherry Martin-Moe, Y. John Wang, Tim Osslund, Tahir Mahmood, Rohini Deshpande, and Susan Hershenson ). 2. Chemical Instability in Peptide and Protein Pharmaceuticals ( Elizabeth M. Topp, Lei Zhang, Hong Zhao, Robert W. Payne, Gabriel J. Evans and Mark Cornell Manning ). 3. Physical Instability in Peptide and Protein Pharmaceuticals ( Byeong Chang and Bernice Yang ). 4. Immunogenicity of Therapeutic Proteins ( Steven J Swanson ). 5. Preformulation Research: Assessing Protein Solution Behavior Early During Therapeutic Development ( Bernardo Perez-Ramirez, Nicholas Guziewicz and Robert Simler ). 6. Formulation Development of Phase I/II Biopharmaceuticals: An Efficient and Timely Approach ( Nicholas W. Warne ). 7. Late Stage Formulation Development and Characterization of Biopharmaceuticals ( Adeolla O Grillo ). 8. An Empirical Phase Diagram/ High Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals ( Sangeeta B. Joshi; Akhilesh Bhambhani; Yuhong Zeng; and C. Russell Middaugh ). 9. Fluorescence and Phosphorescence Methods to Probe Protein Structure and Stability in Ice: the Case of Azurin ( Giovanni Strambini ). 10. Applications of Sedimentation Velocity Analytical Ultracentrifugation ( Tom Laue ). 11. Field Flow Fractionation with Multi-angle Light Scattering for Measuring Particle Size of Virus-like Particles ( Joyce A Sweeney and Christopher Hamm ). 12. Light Scattering Techniques and their Application to Formulation and Aggregation Concerns ( Philip Wyatt and Michael Larkin ). Part 2 Development of a Formulation for Liquid Dosage Form. 13. Efficient Approaches to Formulation Development of Biopharmaceuticals ( Rajiv Nayar and Mitra Mosharraf ). 14. Prediction of Protein Aggregation Propensities from Primary Sequence Information ( Mark Cornell Manning, Gabriel J. Evans, Cody M. Van Pelt and Robert W. Payne ). 15. High Concentration Antibody Formulations ( Steven J. Shire, Jun Liu, Wolfgang Friess, Susanne Matheus and Hanns-Christian Mahler ). 16. Development of Formulations for Therapeutic Monoclonal Antibodies and Fc Fusion Proteins ( Sampath kumar Krishnan, Monica M. Pallitto and Margaret S. Ricci ). 17. Reversible Self-Association of Pharmaceutical Proteins: Characterization and Case Studies ( Vikas K. Sharma, Harminder Bajaj and Devendra S. Kalonia ). Part 3 Development of Formulation for Lyophilized Dosage Form. 18. Design of a Formulation for Freeze Drying ( Feroz Jameel and Mike J. Pikal ). 19. Protein Conformation and Reactivity in Amorphous Solids ( Lei Zhang, Sandipan Sinha and Elizabeth M. Topp ). 20. The Impact of Buffer on Solid-State Properties and Stability of Freeze-Dried Dosage Forms ( Evgenyi Y. Shalaev and Larry A. Gatlin ). 21. Stabilization of Lyophilized Pharmaceuticals by Control of Molecular Mobility: Impact of Thermal History ( Suman Luthra and Micheal J. Pikal ). 22. Structural Analysis of Proteins in Dried Matrices ( Andrea Hawe, Sandipan Sinha, Wolfgang Friess and Wim Jiskoot ). 23. The Impact of Formulation and Drying Processes on the Characteristics and Performance of Biopharmaceutical Powders ( Vu L. Truong and Ahmad M. Abdul-Fattah ). Part 4 Manufacturing Sciences. 24. Manufacturing Fundamentals for Biopharmaceuticals ( Maninder Hora ). 25. Protein Stability during Bioprocessing ( Mark Cornell Manning, Gabriel J. Evans and Robert W. Payne ). 26. Freezing and Thawing of Protein Solutions ( Satish Singh and Sandeep Neema ). 27. Strategies for Bulk Storage and Shipment of Proteins ( Feroz Jameel, Chakradhar Padala and Theodore W. Randolph ). 28. Drying Process Methods for Biopharmaceutical Products: An Overview ( Ahmad M. Abdul-Fattah and Vu L. Truong ). 29. Spray Drying of Biopharmaceuticals and Vaccines ( Jim Searles and Govindan (Dan) Mohan ). 30. Development and Optimization of Freeze Drying Process ( Feroz Jameel and Jim Searles ). 31. Considerations for Successful Lyophilization Process Scale-up, Technology Transfer and Routine Production ( Samir Sane and Chung C. Hsu ). 32. Process Robustness in Freeze-Drying of Biopharmaceuticals ( D.Q. Wang, D. MacLean and X. Ma ). 33. Filling Processes and Technologies for Liquid Biopharmaceuticals ( Ananth Sethuraman, Xiaogang Pan, Bhavya Mehta and Vinay Radhakrishnan ). 34. Leachables and Extractables ( Jim Castner, Pedro Benites and Michael Bresnick ). 35. Primary Container/Closure Selection for Biopharmaceuticals ( Olivia Henderson ). 36. Pre-filled Syringes for Biopharmaceuticals ( Robert Swift and Robin Hwang ). 37. Impact of Manufacturing Processes on the Drug Product Stability and Quality ( Nitin Rathore, Rahul S. Rajan and Erwin Freund ). Index.