Evaluating the Impact of Polysorbate 20 Hydrolysis During the Life-time of Protein Formulation: A De-risking Case Study

09:30 - 10:05

Polysorbates are commonly used in biotherapeutic formulations to protect against interfacial stresses encountered during handling, manufacturing, and transportation processes. They are known to degrade by hydrolysis and contribute to potential protein instability. This presentation discusses a formulation-specific understanding of polysorbate 20 hydrolysis, evaluates the effect on protein stability in pharmaceutically relevant storage and shipping conditions, and presents a de-risking strategy to support inclusion of polysorbate 20 in the current formulation.

Keethkumar Jain, Senior Scientist Drug Product Development , Takeda