Engineering Commons^™

Biophysical Characterization Approaches To Aid The Selection Of Protein Formulations By Predicting Their Physical Stability During Long-Term Storage, Hristo Svilenov, Gerhard Winter

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

The formulation of therapeutic proteins is a critical process which aims at finding the most suitable conditions that impede protein degradation during long-term storage. One degradation path of high interest is the non-native aggregation¹. The latter can be greatly suppressed by the selection of suitable solution conditions². Over the years, various biophysical techniques have been explored as tools to quickly select the most promising formulations for long-term storage.

In this talk, we share the experience in our lab how some of these techniques can be integrated into protein formulation studies. We discuss the application of differential …

A Novel Technique To Characterize The Surface Hydrophobicity Of Proteins Using Inverse Liquid Chromatography, Dilip Sethi, Sarah Hedberg, Daryl Williams

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

This work presents a novel technique to characterize the surface hydrophobicity and other surface properties of proteins. The surface properties of industrial and therapeutic proteins are key to understanding their behavior in-situ, in the laboratory and in processes. Protein surface hydrophobicity is a marker for three dimensional structure, stability and function. Inverse Liquid Chromatography of Proteins (ILCP) with small molecule hydrophobic probes can be used to obtain direct measurements of the surface hydrophobicity of column resin-bound proteins using changes in probe retention behavior. The dimensionless hydrophobicity factor (H_f) for Lysozyme and BSA was obtained with changing pH …

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 …

Conference Program, Samiul Amin, Paolo Arosio, Miguel Rodrigues

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

No abstract provided.