A Comprehensive Assessment of All-Oleate Polysorbate 80: Free Fatty Acid Particle Formation, Interfacial Protection and Oxidative Degradation

Purpose Enzymatic polysorbate (PS) degradation and resulting free fatty acid (FFA) particles are detrimental to biopharmaceutical drug product (DP) stability. Different types and grades of polysorbate have varying propensity to form FFA particles. This work evaluates the homogenous all-oleate (AO) P...

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Veröffentlicht in:	Pharmaceutical research 2021-03, Vol.38 (3), p.531-548
Hauptverfasser:	Doshi, Nidhi, Giddings, Jamie, Luis, Lin, Wu, Arthur, Ritchie, Kyle, Liu, Wenqiang, Chan, Wayman, Taing, Rosalynn, Chu, Jeff, Sreedhara, Alavattam, Kannan, Aadithya, Kei, Pervina, Shieh, Ian, Graf, Tobias, Hu, Mark
Format:	Artikel
Sprache:	eng
Schlagworte:	Air-water interface Antioxidants Biochemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Biopharmaceuticals Chemistry Chemistry, Multidisciplinary Degradation Fatty acids Life Sciences & Biomedicine Medical Law Methionine Monoclonal antibodies Oxidation Pharmacology & Pharmacy Pharmacology/Toxicology Pharmacy Physical Sciences Placebos Research Paper Science & Technology Surface active agents Surface activity Tryptophan
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