ANALYSIS OF MONOCLONAL ANTIBODY AND PROTEIN AGGREGATES INDUCED BY DENATURATION USING A NOVEL SEC COLUMN

Introduction 

Degradation studies of biotherapeutic proteins are necessary to test their stability. The best way to test the suitability of a method is the use of real-time stability samples containing all relevant degradation products that might occur over time. Certain factors, such as product development timeline, process characteristics, excipients, and other environmental factors, however, make the use of a forced degradation study necessary. The biological phenomenon of protein aggregation is a major issue in therapeutic protein development, since the presence of these impurities reduces the potency of the drug formulation, even if non-toxic. Monoclonal antibody proteins, widely being used in the field of biotherapeutics, with the potential to replace small molecules in the future, must be free from these aggregate impurities.