Protein aggregation: New investigative tools and emerging mechanistic understanding
Ajit S Narang
Bristol-Myers Squibb, Co., USA
: J Pharm Drug Deliv Res
Abstract
Emerging data suggests that aggregation instability of a ready-to-use protein solution drug product may be linked to the shear forces experienced by the protein during downstream purification. Sustained conformational changes due to shear during processing may contribute to long-range hydrophobic protein-protein interactions in protein solutions. These interactions manifest in changes in the physicochemical properties of proteins including viscosity and hydrodynamic diameter, in addition to protein aggregation during accelerated stability testing. These observations provide an experimental framework to develop an early predictor of aggregation instability.
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