Influence and effect of osmolytes in biopharmaceutical formulations.

摘要: Abstract Osmolytes are small organic molecules accumulated by cells in response to environmental stresses. They represented amino acids, sugars, polyols, tertiary sulphonium and quaternary ammonium compounds. These present a protective behaviour favour the equilibrium of macromolecules towards native form, preventing denaturation promoting folding unfolded proteins. Protein formulations due their biological character require greater care during manufacturing process, shelf-life administration drug, as variations these factors may result denaturation, inactivation and/or protein aggregation. drawbacks can be surpassed using osmolytes excipients stabilisers, bulking agents even buffers. A number 133 biologics, including vaccines immunoglobulins, approved U.S. Food Drug Administration (FDA) between 1998 2017 were analysed this work order identify most used group osmolyte molecules. deep insight into role was discussed compared data literature. The advantages disadvantages use specific also extensively here. In conclusion, investigation each formulation is essential for understanding effect provides background when selecting best fit without excluding patient needs.