Understanding Surfactant Excipients In Biologic Formulations

Surfactants such as polysorbates and poloxamers play an essential role in stabilizing biologics and gene and cell therapy products, yet their behavior and degradation pathways can significantly impact product quality. Takean in‑depth look at the root causes of polysorbate degradation, emphasizing how factors like free‑fatty‑acid formation influence long‑term stability. Attendees will gain detailed insights into the characterization of commonly used surfactants and learn how advanced analytical approaches can support more reliable formulation development.

A central focus of the session is the application of multidimensional liquid chromatography, which integrates online protein removal with a universal analytical method suitable for both polysorbates and poloxamers. This approach enhances accuracy, improves workflow efficiency, and reduces the complexity associated with traditional offline sample preparation.

Discover new research findings and provide a phase‑appropriate strategy for building a robust surfactant characterization toolbox throughout development. Overall, participants will learn how improved analytical understanding of surfactant stability can help mitigate formulation risks and strengthen product performance.