Formulation, Characterization, and Stability of Protein Drugs

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 This ready reference also features recent data and an abundance of previously unpublished information.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.

Inhalt
A Compendium and Hydropathy/ Flexibility Analysis of Common Reactive Sites in Proteins: Reactivity at Asn, Asp, Gin, and Met Motifs in Neutral pH Solution.- Characterization, Stability, and Formulations of Basic Fibroblast Growth Factor.- The Characterization, Stabilization, and Formulation of Acidic Fibroblast Growth Factor.- Stability, Characterization, Formulation, and Delivery System Development for Transforming Growth Factor-Beta1.- Stability and Characterization of Recombinant Human Relaxin.- Interferon-?-1b (Betaseron®): A Model for Hydrophobic Therapeutic Proteins.- Characterization, Formulation, and Stability of Neupogen® (Filgrastim), a Recombinant Human Granulocyte-Colony Stimulating Factor.- Development and Shelf-Life Determination of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (LEUKINE®, GM-CSF).- Formulation Development of an Antifibrin Monoclonal Antibody Radiopharmaceutical.- Biophysical Characterization and Formulation of TP40: A Chimeric Protein that Requires a pH-Dependent Conformational Change for Its Biological Activity.- Stability Characterization and Formulation Development of Recombinant Human Deoxyribonuclease I [Pulmozyme®, (Dornase Alpha)].