Evaluation of Protein Aggregation Under Various Stress Conditions Using the Aggregates Sizer

Biopharmaceuticals have recently gained attention for their specificity in attacking pathogens, relative lack of side effects, and potent effect. However, compared with low molecular weight pharmaceuticals, biopharmaceuticals are more susceptible to stress, and more likely to aggregate. When a biopharmaceutical aggregates due to stress, this results in a decrease or disappearance of its pharmacological effect, along with the potential for causing serious side effects such as shock symptoms from an immunological reaction. Consequently, a framework is being established that evaluates the stability of biopharmaceuticals in terms of their susceptibility to likely stresses.This article describes how we applied heat and physical stress to intravenous immunoglobulin (IVIG), then evaluated aggregate formation using the Aggregates Sizer.