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

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

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...

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Bibliographic Details
Main Authors: Inn H. Yuk, Theo Koulis, Nidhi Doshi, Kathrin Gregoritza, Constanze Hediger, Vanessa Lebouc-Haefliger, Jamie Giddings, Tarik A. Khan
Format: Article
Language:English
Published: SpringerOpen 2022-11-01
Series:AAPS Open
Subjects:
Free fatty acids
Formulation design
Particles
Polysorbate degradation
Stability
Statistical analysis
Online Access:https://doi.org/10.1186/s41120-022-00064-3

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