Characterization of Monoclonal Antibody Formulations During Long-Term Storage

The development of the use of proteins, especially monoclonal antibodies (mAbs), as therapeutic molecules has provided many challenges. In particular, proteins are not very stable relative to small molecule drugs and mAbs are prone to unfolding and aggregation at the high concentrations required for efficacy. Furthermore, their large size and numerous surface-exposed functional groups make these proteins prone to several chemical degradation pathways. They are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content of buffer and shear. Aggregation problems have been implicated in adverse reactions since the beginning of clinical applications of protein pharmaceuticals.