Therapeutic antibody formulation: Phase behavior, opalescence, viscosity, physical and chemical stability
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BA Salinas
2009
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Therapeutic monoclonal antibodies (mAbs) are promising drug candidates and have become the fastest growing type of therapeutic in development. However, antibodies are large, complex proteins that can exhibit a wide range of solution behaviors that are not desirable for therapeutic applications. These include chemical instability of the peptide sequence, precipitation of native or non-native aggregates, opalescence and high viscosity. These behaviors present economic and safety issues throughout the development …