Formulation, Characterization, and Stability of Protein Drugs

1. Front Matter

   Pages i-xxviii

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2. A Compendium and Hydropathy/ Flexibility Analysis of Common Reactive Sites in Proteins: Reactivity at Asn, Asp, Gin, and Met Motifs in Neutral pH Solution

   • Michael F. Powell, Godfrey Amphlett, Jerry Cacia, William Callahan, Eleanor Cannova-Davis, Byeong Chang et al.

   Pages 1-140

3. Characterization, Stability, and Formulations of Basic Fibroblast Growth Factor

   • Y. John Wang, Zahra Shahrokh, Sriram Vemuri, Gert Eberlein, Irina Beylin, Mark Busch

   Pages 141-180

4. The Characterization, Stabilization, and Formulation of Acidic Fibroblast Growth Factor

   • David B. Volkin, C. Russell Middaugh

   Pages 181-217

5. Stability, Characterization, Formulation, and Delivery System Development for Transforming Growth Factor-Beta1

   • Wayne R. Gombotz, Susan C. Pankey, Lisa S. Bouchard, Duke H. Phan, Alan P. MacKenzie

   Pages 219-245

6. Stability and Characterization of Recombinant Human Relaxin

   • Tue H. Nguyen, Steven J. Shire

   Pages 247-274

7. Interferon-β-1b (Betaseron®): A Model for Hydrophobic Therapeutic Proteins

   • Leo S. Lin, Michael G. Kunitani, Maninder S. Hora

   Pages 275-301

8. Characterization, Formulation, and Stability of Neupogen® (Filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor

   • Alan C. Herman, Thomas C. Boone, Hsieng S. Lu

   Pages 303-328

9. Development and Shelf-Life Determination of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (LEUKINE®, GM-CSF)

   • John Geigert, Barbara F. D. Ghrist

   Pages 329-342

10. Formulation Development of an Antifibrin Monoclonal Antibody Radiopharmaceutical

    • Madhav S. Kamat, Glen L. Tolman, John M. Brown

    Pages 343-364

11. Biophysical Characterization and Formulation of TP40: A Chimeric Protein that Requires a pH-Dependent Conformational Change for Its Biological Activity

    • Gautam Sanyal, Dorothy Marquis-Omer, C. Russell Middaugh

    Pages 365-392

12. Stability Characterization and Formulation Development of Recombinant Human Deoxyribonuclease I [Pulmozyme®, (Dornase Alpha)]

    • Steven J. Shire

    Pages 393-426

13. Back Matter

    Pages 427-432

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Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

• Herman
• delivery
• development
• drugs
• interferon
• pharmaceutical
• preparation
• protein
• research

• Megabios Corporation, Burlingame, USA

  Rodney Pearlman

• Scios Nova, Inc., Mountain View, USA

  Y. John Wang

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