共 278 条
[1]
Dwivedi M(2018)Polysorbate degradation in biotherapeutic formulations: identification and discussion of current root causes Int J Pharm 552 422-436
[2]
Blech M(2010)Adsorption behavior of a surfactant and a monoclonal antibody to sterilizing-grade filters J Pharm Sci 99 2620-2627
[3]
Presser I(2008)Behaviour of polysorbate 20 during dialysis, concentration and filtration using membrane separation techniques J Pharm Sci 97 764-774
[4]
Garidel P(1998)Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions J Pharm Sci 87 1554-1559
[5]
Mahler H-C(2008)Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways J Pharm Sci 97 2924-2935
[6]
Huber F(2012)Analysis of polysorbate 80 and its related compounds by RP-HPLC with ELSD and MS detection J Chromatogr Sci 50 598-607
[7]
Kishore RS(1997)Composition analysis of detergents of the polyoxyethylene type: comparison of thin-layer chromatography, reversed-phase chromatography and matrix-assisted laser desorption/ionization mass spectrometry J Chromatogr A 791 245-253
[8]
Reindl J(2014)Characterization and stability study of polysorbate 20 in therapeutic monoclonal antibody formulation by multidimensional ultrahigh-performance liquid chromatography–charged aerosol detection–mass spectrometry Anal Chem 86 5150-5157
[9]
Rückert P(2011)Mixed-mode and reversed-phase liquid chromatography–tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80 J Chromatogr A 1218 2138-2145
[10]
Müller R(2015)Understanding particle formation: solubility of free fatty acids as Polysorbate 20 degradation byproducts in therapeutic monoclonal antibody formulations Mol Pharm 12 3792-3804