Biomedical Engineering and Bioengineering Commons^™

Aggregation Challenges In The Formulation Development Of Multi-Dose Peptide Products, Jingtao Zhang, Katelyn Smith, Wei Xu, Yongchao Su, Suzanne D’Addio, Yogita Krishnamachari, Jameson Bothe, Daniel Yin, Xinpei Mao

Biological and Pharmaceutical Complex Fluids III: Protein Self-Assembly, Rheology and Interfacial Properties

The formulation development of parenteral peptide therapeutics frequently encounters aggregation challenges. In-depth biophysical understanding of the molecule and formulation are required to achieve formulation robustness. Further, unique considerations need to be given for peptide products that require multi-dose as the use of preservatives can promote aggregation while preservative effectiveness can also be impacted by its interaction with the peptide. This presentation will focus on the reversible and irreversible fibril aggregates in peptide formulations. Biophysical characterization of aggregation and formulation will be discussed in detail. Formation of reversible aggregates and the impact of excipients especially preservatives will be discussed. For the …