Monoclonal antibodies are proteinaceous in nature and are subject to instability issues. Stability testing of monoclonal antibodies is a critical regulatory requirement in their development and commercialization as therapeutic biological molecules. This article reviews the numerous drug manufacturing processes such as: upstream processing, downstream purification and aseptic filling along with physical and chemical factors such as protein concentration, structure, pH, temperature, light, agitation, deamidation, oxidation, glycation leading to instabilities in monoclonal antibodies and it spotlights the variety of analytical techniques employed to investigate and generate information on stability studies and henceforth, helps in developing the stability-indicating methods. In addition, this paper aims to discuss the ICH regulatory guideline (s) for the stability assessment of biological products (Drug Substance and Drug Product).
Keywords: regulatory guideline; Monoclonal antibodies; aggregation; stability; therapeutics.