Competitive Adsorption of Monoclonal Antibodies and Nonionic Surfactants at Solid Hydrophobic Surfaces

被引:44
作者
Kapp, Sebastian J. [1 ]
Larsson, Iben [2 ]
Van De Weert, Marco [1 ]
Cardenas, Marite [3 ,4 ]
Jorgensen, Lene [1 ]
机构
[1] Univ Copenhagen, Dept Pharm, DK-2100 Copenhagen, Denmark
[2] Amgros IS, DK-2400 Copenhagen, Denmark
[3] Univ Copenhagen, Dept Chem, DK-2100 Copenhagen, Denmark
[4] Malmo Univ, Dept Biochem Sci, S-20506 Malmo, Sweden
关键词
adsorption; protein formulation; physical stability; surfactants; protein; monoclonal antibodies; QCM-D; TIRF; QUARTZ-CRYSTAL MICROBALANCE; IN-SITU ELLIPSOMETRY; HUMAN GROWTH-HORMONE; PROTEIN ADSORPTION; POLYSTYRENE LATTICES; THERMAL-STABILITY; PLASMON RESONANCE; WATER INTERFACES; SODIUM-CHLORIDE; POLYSORBATE; 20;
D O I
10.1002/jps.24265
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Two monoclonal antibodies from the IgG subclasses one and two were compared in their adsorption behavior with hydrophobic surfaces upon dilution to 10 mg/mL with 0.9% NaCl. These conditions simulate handling of the compounds at hospital pharmacies and surfaces encountered after preparation, such as infusion bags and i.v. lines. Total internal reflection fluorescence and quartz crystal microbalance with dissipation monitoring were used to follow and quantify this. Furthermore, the influence of the nonionic surfactant polysorbate 80 (PS80) on the adsorption process of these two antibodies was investigated. Despite belonging to two different IgG subclasses, both antibodies displayed comparable adsorption behavior. Both antibodies readily adsorbed in the absence of PS80, whereas adsorption was reduced in the presence of 30 mg/L surfactant. The sequence of exposure of the surfactant and protein to the surface was found to have a major influence on the extent of protein adsorption. Although only a fraction of adsorbed protein could be removed by rinsing with 30 mg/L surfactant solution, adsorption was entirely prevented when surfaces were pre-exposed to PS80. (c) 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:593-601, 2015
引用
收藏
页码:593 / 601
页数:9
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