Stability Studies of Proteinous Compounds

Protein stability is a subject of great interest to the pharmaceutical, biotechnological, and food industry, as well as, for academic researchers who are studying proteins on regular basis. The stability of proteins is important to understand the optimization of protein purification, composition, expression, storage, and conformational studies. This study concentrates on the factors affecting the protein stability and type of stability undergone by proteins and chemical kinetics, which provide the designs and modifications of chemical reactors to maximize the product yield of pharmaceuticals and to eliminate hazardous by-products. A brief introduction of conformational and compositional protein stability will be discussed for analyzing protein stability by key methods. The importance of the different methods followed for pharmaceutical product stability testing, guidelines given by the ICH, FDA, WHO, and other agencies for stability testing, and other aspects related to pharmaceutical product stability will be discussed in a concise manner in the present study.