Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study

• Main Authors: Inn H. Yuk (Author), Theo Koulis (Author), Nidhi Doshi (Author), Kathrin Gregoritza (Author), Constanze Hediger (Author), Vanessa Lebouc-Haefliger (Author), Jamie Giddings (Author), Tarik A. Khan (Author)
• Format: Book
• Published: SpringerOpen, 2022-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Hydrolytic degradation of the polysorbate 20 (PS20) surfactant in protein-based liquid formulations releases free fatty acids (FFAs), which can accumulate to form particles in drug products during real-time (long-term) storage. To identify formulation conditions that mitigate the risk of pa...