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AAPS PharmSciTech

, Volume 19, Issue 1, pp 79–92 | Cite as

Effect of Surfactants on Mechanical, Thermal, and Photostability of a Monoclonal Antibody

  • Meera AgarkhedEmail author
  • Courtney O’Dell
  • Ming-Ching Hsieh
  • Jingming Zhang
  • Joel Goldstein
  • Arvind Srivastava
Review Article

Abstract

The purpose of this work was to evaluate the effect of commonly used surfactants (at 0.01% w/v concentration) on mechanical, thermal, and photostability of a monoclonal antibody (MAb1) of IgG1 sub-class and to evaluate the minimum concentration of surfactant (Polysorbate 80) required in protecting MAb1 from mechanical stress. Surfactants evaluated were non-ionic surfactants, Polysorbate 80, Polysorbate 20, Pluronic F-68 (polyoxyethylene-polyoxypropylene block polymer), Brij 35 (polyoxyethylene lauryl ether), Triton X-100, and an anionic surfactant, Caprylic acid (1-Heptanecarboxylic acid). After evaluating effect of surfactants and determining stabilizing effect of Polysorbate 80 against mechanical stress without compromising thermal and photostability of MAb1, the minimum concentration of Polysorbate 80 required for mechanical stability was further examined. Polysorbate 80 concentration was varied from 0 to 0.02%. Mechanical stability was evaluated by agitation of MAb1 at 300 rotations per minute at room temperature for 72 h. Samples were analyzed for purity by SEC-HPLC, turbidity by absorbance at 350 nm, visible particles by visual inspection, and sub-visible particles by light obscuration technique on a particle analyzer. All non-ionic surfactants tested showed a similar effect in protecting against mechanical stress and did not exhibit any significant negative effect on thermal and photostability. However, Caprylic acid had a slightly negative effect on mechanical and photostability when compared to the non-ionic surfactants or sample without surfactant. This work demonstrated that polysorbate 80 is better than other surfactants tested and that a concentration of at least 0.005% (w/v) Polysorbate 80 is needed to protect MAb1 against mechanical stress.

KEY WORDS

monoclonal antibody non-ionic surfactants anionic surfactant mechanical stability photostability 

Notes

Acknowledgements

We greatly appreciate the help of the analytical support group in analyzing the study samples by SEC-HPLC and IEC-HPLC.

Compliance with Ethical Standards

Conflict of Interest

The authors have no personal financial or non-financial conflicts of interest in the publication of results contained in this manuscript.

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Copyright information

© American Association of Pharmaceutical Scientists 2017

Authors and Affiliations

  • Meera Agarkhed
    • 1
    Email author
  • Courtney O’Dell
    • 1
  • Ming-Ching Hsieh
    • 1
  • Jingming Zhang
    • 1
  • Joel Goldstein
    • 1
  • Arvind Srivastava
    • 1
  1. 1.Formulation DevelopmentEli Lilly and CompanyBranchburgUSA

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