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

该项目将描述在不同工艺条件下合成/制造治疗肽和药物产品过程中产生的化学和有机杂质，探索这些杂质与肽的物理稳定性之间的关系。目的是更好地了解凝胶和纤维形成的机制（药物产品和许多其他治疗性肽容易形成）以及这与不同加工条件的关系。我们的目标是确定早期纤维形成的预测因素，导致合成肽制剂的物理不稳定性。

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.