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Description: |
xx, 955 pages : illustrations (some color) ; 25 cm |
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Bibliography Note: |
Includes bibliographical references and index. |
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Contents Note: |
Contents: Part I: Preformulation and development of stability-indicating assays: biophysical charachterization techniques -- The structure of biological therapeutics / Sheryl Martin-Moe [and others] -- Chemical instability in peptide and protein pharmaceuticals / Elizabeth M. Topp [and others] -- Physical stability of protein pharmaceuticals / Byeong S. Chang and Bernice Yeung -- Immunogenicity of therapeutic proteins / Steven J. Swanson -- Preformulation research: assessing protein solution behavior during early development / Bernardo Perez-Ramirez, Nicholas Guziewicz, and Robert Simler -- Formulation development of phase 1-2 biopharmaceuticals: an efficient and timely approach / Nicholas W. Warne -- Late-stage formulation development and characterization of biopharmaceuticals / Adeola O. Grillo -- An empirical phase diagram: high-throughput screening and approach to the characterization and formulation of biopharmaceuticals / Sangetta B. Joshi [and others] -- Fluorescence and phosphorescence methods to probe protein structure and stability in ice: the case of azurin / Giovanni B. Strambini -- Applications of sedimentation velocity analytical ultracentrifugation / Field flow fractionation with multiangle light scattering for measuring particle size distributions of virus-like particles / Joyce A. Sweeney and Christopher Hamm -- Light-scattering techniques and their application to formulation and aggregation concerns / Michael Larkin and Philip Wyatt -- Part II: Development of a formulation for liquid dosage form -- Effective approaches to formulation development of biopharmaceuticals / Rajiv Nayar and Mitra Mosharraf -- Prediction of aggregation propensity from primary sequence information / Mark Cornell Manning [and others] -- High-concentration antibody formulations / Steven J. Shire [and others] -- Development of formulations for therapeutic monoclonal antibodies and Fc fusion proteins / Sampathkumar Krishnan, Monica M. Pallitto, and Margaret S. Ricci -- Reversible self-association of pharmaceutical proteins: characterization and case studies / Vikas K. Sharma, Harminder Bajaj, and Devendra S. Kalonia -- Part III: Development of a formulation for lyophilized dosage form -- Design of a formulation for freeze drying / Feroz Jameel and Mike J. Pikal -- Protein conformation and reactivity in amorphous solids / Lei Zhang, Sandipan Sinha, and Elizabeth M. Topp -- The impact of buffer on solid-state properties and stability of freeze-dried dosage forms / Evgenyi Y. Shalaev and Larry A. Gatlin -- Stabilization of lyophilized pharmaceuticals by control of molecular mobility: impact of thermal history / Suman Luthra and Michael J. Pikal -- Structural analysis of proteins in dried matrices / Andrea Hawe .. [et al.] -- The impact of formulation and drying processes on the characteristics and performance of biopharmaceutical powders / Vu L. Truong and Ahmad M. Abdul-Fattah -- Part IV: Manufacturing services -- Manufacturing fundamentals for biopharmaceuticals / Maninder Hora -- Protein stability during bioprocessing / Mark Cornell Manning, Gabriel J. Evans, and Robert W. Payne -- Freezing and thawing of protein solution / Satish K. Singli and Sandeep -- Strategies for bulk storage and shipment of proteins / Feroz Jameel, Chakradhar Padala, and Theodore W. Randolph -- Drying process methods for biopharmaceutical products: an overview / Ahmad M. Abul-Fattah and Vu L. Truong -- Spray drying of biopharmaceuticals and vaccines / Jim Searles and Govindan Mohan -- Development and optimization of the freeze-drying processes / Feroz Jameel and Jim Searles -- Considerations for successful lyophilization proces scale-up, technology transfer, and routine production / Samir U. Sand and Chung C. Hsu -- Process robustness in freeze drying of biopharmaceuticals / D.Q. Wang, D. MacLean, and X. Ma -- Filling processes and technologies for liquid biopharmaceuticals / Anath Sthuraman [and others] -- Leachables and extractables / Jim Castner, Pedro Benites, and Micahel Bresnick -- Primary container and closure selection for biopharmaceuticals / Olivia Henderson -- Prefilled syringes for biopharmaceuticals / Robert Swift -- Impact of manufacturing processes on drug product stability and quality / Nitin Rathore, Rahul S. Rajan, and Erwin Freund. |