Optimization of a formulation requires a detailed understanding of the properties of a macromolecule under a variety of pharmaceutically relevant stresses. Due to the complexity of macromolecular systems, no single analytical method can detect all possible changes in their structures. Thus several methods are generally required to comprehensively characterize a biopharmaceutical under various stress conditions. We employ a variety of techniques sensitive to different properties of target macromolecules to characterize the biophysical properties of the drug candidate under a range of solution conditions.
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