Controlling and quantifying the stability of amino acid-based cargo within polymeric delivery systems

In recent years, the rapid growth and availability of protein and peptide therapeutics has not only expanded the boundaries of modern science but has also revolutionized the practice of medicine today. The potential of such therapies, however, is greatly limited by the innate instabilities of proteins and peptides, which is further magnified during therapeutic formulation processing, transport, storage, and administration. In this paper, we will consider the unique stability challenges associated with protein/peptide polymeric delivery systems from an engineering approach oriented towards the quantification and modification of amino acid-based cargo stability. While a number of methods have been developed for the purposes of quantifying factors affecting protein and peptide stability, current measurement techniques remain largely limited in scope in regard to polymeric drug delivery systems. This paper will primarily describe the influence of water content, pH, and temperature on protein and peptide stability within polymer-based delivery systems. Moreover, we will review current instrumentation used to quantify factors affecting protein/peptide stability with respect to water content, pH, and temperature. Lastly, we will outline several recommendations to help guide future research efforts to develop methods more specific to quantifying protein/peptide stability within polymer-based delivery systems.