Biological Stability of Peptides/Proteins Therapeutic Agents

Many environmental stress parameters and agents influence the physicochemical and biological stability of peptides/proteins therapeutic agents (biopharmaceuticals). They should be examined using the proper methodologies to determine their biological stability, which refers to their stability to changes in biological activity, potency, toxicity, and immunogenicity under various environmental stresses. The biological activity of biopharmaceuticals requires physicochemical stabilities that cannot guarantee their potency and safety. Physicochemical and biological stability has only been studied in a limited number of stability investigations. Consequently, well-documented stability studies of biopharmaceuticals are typically absent. This review aims to provide a synopsis of the use of bioassays in stability studies of biopharmaceuticals (excluding vaccines) to assess their biological stability based on researches published between 2000 and May 2023. In addition, this article includes sections that describe different types of stability studies, the criteria for selecting appropriate bioassays, and the role of bioassays in stability studies of biopharmaceuticals.