Prediction of long-term polysorbate degradation according to short-term degradation kinetics

Autor: Sisi Zhang, Caterina Riccardi, Dane Carlson, Douglas Kamen, Kenneth S. Graham, Mohammed Shameem, Hanne Bak, Hui Xiao, Ning Li
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: mAbs, Vol 15, Iss 1 (2023)
Druh dokumentu: article
ISSN: 19420862
1942-0870
1942-0862
28374819
DOI: 10.1080/19420862.2023.2232486
Popis: ABSTRACTPolysorbates (PSs) are a class of surfactants commonly used in the formulation of protein therapeutic agents to provide protection against denaturation and aggregation. When the PS in these drug formulations degrades, loss of stabilization of the protein therapeutic and formulation may occur, resulting in particulate formation or other undesirable changes in product critical quality attributes. Here, we present a simplified platform to predict long-term PS20 and PS80 degradation for monoclonal antibody drugs containing the PS-degrading enzyme lysosomal acid lipase. The platform was based on a temperature-dependent equation derived from existing PS20 degradation stability data. Accurate prediction of both PS20 and PS80 hydrolysis for as long as 2 years was achieved through short-term kinetics studies performed within 2 weeks. This platform substantially shortens the time required to determine the long-term stability of PS degradation and therefore can be used to guide the purification process and optimization of antibody formulations.
Databáze: Directory of Open Access Journals