Impact of Poloxamer 188 Material Attributes on Proteinaceous Visible Particle Formation in Liquid Monoclonal Antibody Formulations

Surfactants such as Poloxamer 188 (PX188) play an important role in controlling particle formation in biotherapeutic formulations due to interfacial stresses. This study demonstrates for the first time that hydrophobicity of PX188 is a potential critical material attribute (CMA) as far as control of...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2022-08, Vol.111 (8), p.2191-2200
Hauptverfasser:	Soeda, Kohei, Fukuda, Masakazu, Takahashi, Masaya, Imai, Hirotaka, Arai, Kengo, Saitoh, Satoshi, Kishore, Ravuri S.K., Oltra, Nuria Sancho, Duboeuf, Jeremy, Hashimoto, Daisuke, Yamanaka, Yuji
Format:	Artikel
Sprache:	eng
Schlagworte:	Monoclonal antibody Protein aggregation Protein formulation Stability Surfactants
Online-Zugang:	Volltext
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