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QC friendly polysorbate quantification in high concentration protein samples.

Kaylee E Dillard1, Corbin Witmer1, Huy Vinh Tran1

  • 1Analytical Research and Development, Merck & Co., Inc., Rahway, NJ 07065, United States.

Journal of Pharmaceutical and Biomedical Analysis
|June 26, 2026
PubMed
Summary
This summary is machine-generated.

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A new HPLC-CAD method effectively monitors low concentrations of polysorbate (PS) in high-protein biologic drugs. This validated technique ensures drug quality by tracking PS degradation and can be transferred to other testing sites.

Area of Science:

  • Biopharmaceutical analysis
  • Analytical chemistry
  • Drug formulation

Background:

  • Polysorbate (PS) is crucial for stabilizing biologic drugs, preventing aggregation and particle formation.
  • Monitoring low PS concentrations in high-protein formulations (>100 mg/mL) is challenging due to protein interference.
  • Existing analytical methods struggle to isolate PS from complex biologic matrices.

Purpose of the Study:

  • To develop and validate a robust method for quantifying polysorbate in high-protein concentration biologic drug products.
  • To demonstrate the method's applicability to various biologics, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
  • To show the method can track polysorbate degradation in formulated samples.

Main Methods:

  • High-Performance Liquid Chromatography coupled with Charged Aerosol Detection (HPLC-CAD) was employed.
Keywords:
BiopharmaceuticalsHPLC-CADPolysorbate quantificationProtein interference

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Last Updated: Jun 28, 2026

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  • The method was optimized for analyzing samples with protein concentrations exceeding 100 mg/mL.
  • Validation and transferability of the method were assessed.

    • Main Results:

    • The HPLC-CAD method successfully quantified polysorbate (PS-20 and PS-80) in complex biologic formulations.
    • The method demonstrated sensitivity in tracking polysorbate degradation in a high-concentration monoclonal antibody sample.
    • The analytical method proved to be robust and suitable for routine monitoring.

    Conclusions:

    • HPLC-CAD offers a reliable solution for monitoring polysorbate content in challenging high-protein biologic formulations.
    • This validated method supports quality control and stability assessment of biopharmaceutical products.
    • The method's transferability facilitates its adoption across different pharmaceutical testing facilities.