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

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Abstract

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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ACKNOWLEDGMENTS AND DISCLOSURES

The authors thank Matthieu Weber for excellent technical expertise with XPS acquisition. The authors declare no conflicts of interest. 

Funding

GL and RAPJ were supported by an ANRT Cifre PhD grant (2017/0735; 2020/1349). This work was supported by the French National Research Agency in the framework of the “Investissements d’avenir” program (ANR-15-IDEX-02).

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Authors and Affiliations

  1. Univ. Grenoble Alpes, CNRS, Grenoble INP* (*Institute of Engineering) LMGP, 38000, Grenoble, France

    Guillaume Lefebvre, Antoine Maze, Rosa Alvarez-Palencia Jimenez, Franz Bruckert & Marianne Weidenhaupt

  2. Sanofi, 94400, Vitry-sur-Seine, France

    Guillaume Lefebvre, Rosa Alvarez-Palencia Jimenez, Vasco Filipe & Sylvain Huille

  3. Phelma Minatec LMGP, 3 parvis Louis Neel, CS 50257, F- 38016, Grenoble cedex 1, France

    Marianne Weidenhaupt

Authors
  1. Guillaume Lefebvre
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  2. Antoine Maze
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  3. Rosa Alvarez-Palencia Jimenez
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  4. Franz Bruckert
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  5. Vasco Filipe
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  6. Sylvain Huille
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  7. Marianne Weidenhaupt
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Contributions

GL developed the methodology and did the experimental work together with AM and RAPJ; VF and SH provided the molecules for the study; VF, SH, FB and MW are responsible for the supervision, the conceptualization, the formal analysis and the validation; GL and MW prepared the manuscript; VF and SH together with FB and MW secured the funding.

Corresponding author

Correspondence to Marianne Weidenhaupt.

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Lefebvre, G., Maze, A., Alvarez-Palencia Jimenez, R. et al. Surfactant Protection Efficacy at Surfaces Varies with the Nature of Hydrophobic Materials. Pharm Res 38, 2157–2166 (2021). https://doi.org/10.1007/s11095-021-03133-6

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  • DOI: https://doi.org/10.1007/s11095-021-03133-6

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