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    Surfactant Protection Efficacy at Surfaces Varies with the Nature of Hydrophobic Materials

    Year: 2021

    Journal: Pharm. Res., Volume 38, DEC, page 2157–2166

    Authors: Lefebvre, Guillaume; Maze, Antoine; Jimenez, Rosa Alvarez-Palencia; Bruckert, Franz; Filipe, Vasco; Huille, Sylvain; Weidenhaupt, Marianne

    Organizations: ANRT Cifre PhD grant [2017/0735, 2020/1349]; French National Research Agency [ANR-15-IDEX-02]

    Keywords: formulation optimization; monoclonal antibody; plastic materials; surface adsorption; surfactant protection

    Objective Monoclonal antibodies are in contact with many different materials throughout their life cycle from production to patient administration. Plastic surfaces are commonly found in single use bags, syringes, perfusion bags and tubing and their hydrophobic nature makes them particularly prone for adsorption of therapeutic proteins. The addition of surfactants in therapeutic formulations aims at minimizing surface and interface adsorption of the active molecules. However, their protection efficacy related to the nature of the plastic material is still poorly investigated. Methods We use real-time surface-sensitive techniques and immunosorbent assays, to quantify surfactant and monoclonal antibody adsorption on hydrophobic model surfaces and different plastic polymers to analyse the effect of material surface properties on the level of surfactant protection. Results We show that Polysorbate 80 protects monoclonal antibodies significantly better from adsorption on a polystyrene surface than on a hexadecane self-assembled monolayer, used as a model surface with similar hydrophobicity. This enhanced protective effect on polystyrene is observed for different antibodies and also other surfactants, and its extent depends on the surfactant concentration for a given antibody concentration. A comparative adsorption study allows ranking different in-use plastics and highlights the dependence of Polysorbate 80 protection efficacy on the nature of the plastic material. Conclusion This study demonstrates that, beyond hydrophobicity, the nature of plastic polymer surfaces affects surfactant adsorption and thereby impacts their protection efficacy in therapeutic antibody formulations.
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