Degradation of Polysorbate 20 by Sialate O-Acetylesterase in Monoclonal Antibody Formulations

Polysorbates (PS) are surfactants commonly added in biologics formulations that can protect proteins from denaturation and aggregation. However, decreases in polysorbate 20 (PS20) content have been observed in some monoclonal antibody formulations, causing the formation of visible and/or subvisible...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2021-12, Vol.110 (12), p.3866-3873
Hauptverfasser:	Zhang, Sisi, Xiao, Hui, Li, Ning
Format:	Artikel
Sprache:	eng
Schlagworte:	Acetylesterase Antibodies, Monoclonal Degradation pattern Depletion Drug Compounding - methods Host cell proteins Polysorbates Polysorbates - metabolism SIAE Surface-Active Agents
Online-Zugang:	Volltext
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