Protein aggregation is a biological phenomenon caused by the abnormal interaction of destabilized proteins.1 Characterization of protein behavior in solution is critical, as destabilized proteins are susceptible to chemical and physical alterations leading to loss of function. Most importantly, in protein-based drug development, even minimal amounts of aggregates can cause deleterious effects due to potential change in potency of biopharmaceuticals, and adverse immune response in patients. In addition, the increasing number of biosimilars demands stringent regulatory procedures that properly address product quality analysis by biopharmaceutical companies.3 Many factors can influence protein behavior and aggregation, including temperature, oxidation, concentration, pH, ionic strength, additives, detergent, cryoprotectants, freeze-thaw cycles, and storage and handling conditions. This article explores Ultracentrifugation as a complete workflow solution for protein purification and protein aggregation quantification.
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