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

本项目将对不同工艺条件下治疗性肽和制剂合成/生产过程中产生的化学和有机杂质进行定性分析，探索这些杂质与肽物理稳定性之间的关系。目的是更好地了解凝胶和原纤维形成的机制（药物产品和许多其他治疗肽易于形成）以及这与不同加工条件的关系。我们的目标是确定导致合成肽制剂物理不稳定性的早期原纤维形成的预测因子。

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.