Stability of protein pharmaceuticals: an update

Overview of chemical and physical degradation pathways of peptides and proteins such as deamidation, oxidation and aggregation, and of stabilising measures.

Key points

• Chemical instability includes deamidation, oxidation, hydrolysis and disulfide exchange, among others.
• Physical instability mainly concerns aggregation and adsorption to surfaces.
• Temperature, pH, moisture and formulation determine which degradation pathways dominate.

Assessment

The paper deals with protein pharmaceuticals, but the mechanisms described largely apply to shorter peptides as well. It underpins the storage guidance in our article Lyophilisate: storage and stability.