The Effect of Manufacturing Processes on the Physical Stability of Therapeutic Peptides

The project will characterise the chemical and organic impurities arising during the synthesis/manufacture of therapeutic peptide and drug product under different process conditions, exploring the relationship between these impurities and the physical stability of the peptide. The aim will be to gain a better understanding of the mechanisms underlying gel and fibril formation (to which drug product and many other therapeutic peptides are prone) and how this relates to the different processing conditions. We will aim to identify predictors of early fibril formation leading to physical instability in synthetic peptide formulations.