Fig. 2. Figure depicts the issues associated with protein-based therapies' stabilities, notably influencing their efficacy and safety attributes. This figure illustrates the critical role of stability in the development of protein-based therapy. Ensuring stability is crucial to maintain the efficacy and functionality of protein-based therapies throughout manufacturing, storage, and delivery processes. Structural instability, arising from misfolding, unfolding, various modifications, and aggregation, can impair drug efficacy. Proteins and peptides exhibit a limited stability range influenced by factors such as concentration, ionic strength, temperature, and pH often referred to as “marginal stability”. Furthermore, proteins face additional challenges caused by proteases, immune responses and human physiological conditions that can impact their stability.