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AAPS PharmSciTech

, Volume 13, Issue 2, pp 422–430 | Cite as

Effect of Polysorbate 80 Quality on Photostability of a Monoclonal Antibody

  • Swita R. SinghEmail author
  • Jingming Zhang
  • Courtney O’Dell
  • Ming-Ching Hsieh
  • Joel Goldstein
  • Joseph Liu
  • Arvind Srivastava
Research Article

Abstract

Polysorbate 80 is one of the key components of protein formulations. It primarily inhibits interfacial damage of the protein molecule due to mechanical stress during shipping and handling. However, polysorbate 80 also affects the formulation photostability. Exposure to light of polysorbate 80 aqueous solution results in peroxide generation, which in turn may result in oxidation of the susceptible amino acid residues in the protein molecule. The purpose of this study was to determine if the photostability of our proprietary IgG1 monoclonal antibody formulation containing polysorbate 80 is affected by the quality (grade/vendor) of polysorbate 80. Following four types of polysorbate80 were tested: (1) Polysorbate 80 Super-Refined, Mallinckrodt Baker, (2) Polysorbate 80 NF, Mallinckrodt Baker, (3) Polysorbate 80 NF, EMD Chemicals, and (4) Ultra-pure Polysorbate 80 (HX), NOF Corporation. The samples were exposed to light as per ICH guidelines Q1B. The results of the study show that photostability of the antibody formulation is indeed affected by the quality of polysorbate 80. This study underscores the importance of carefully choosing the quality of polysorbate 80 to ensure the robustness of formulation.

Key words

antibody photostability polysorbate 80 protein stability Super-Refined Polysorbate 80 

Notes

Conflicts of interest declaration

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 2012

Authors and Affiliations

  • Swita R. Singh
    • 1
    Email author
  • Jingming Zhang
    • 1
  • Courtney O’Dell
    • 1
  • Ming-Ching Hsieh
    • 1
  • Joel Goldstein
    • 1
  • Joseph Liu
    • 1
  • Arvind Srivastava
    • 1
  1. 1.ImClone Systems, a Wholly Owned Subsidiary of Eli Lilly & Co.BranchburgUSA

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