What the study found
An HPLC method with evaporative light scattering detection (ELSD) was validated across multiple laboratories for measuring polysorbate 80 (PS80) in therapeutic monoclonal antibodies. The method was reported to accurately measure PS80 concentrations from 0.05 to 0.5 mg/mL.
Why the authors say this matters
The authors conclude that PS80 is an important surfactant in therapeutic monoclonal antibodies because it helps prevent aggregation and stabilize the drug product. They state that the validated method can be recommended for release and quality control testing of PS80 concentration in therapeutic mAbs.
What the researchers tested
The researchers developed an HPLC-ELSD method for multiproduct analysis of PS80 and carried out method validation across multiple laboratories using different instruments and ELSD detectors. They validated the method with various IgG monoclonal antibodies and different sources of PS80.
What worked and what didn't
The method worked across multiple laboratories and was reported to measure PS80 accurately in the tested concentration range of 0.05 to 0.5 mg/mL. Robustness testing showed that the method tolerated up to 160 mg/mL mAb interference when sample dilution or protein precipitation was used.
What to keep in mind
The abstract does not describe detailed limitations beyond noting that other published PS80 methods have their own limitations. The results are reported for the specific mAbs, PS80 sources, instruments, and detector types included in the validation.
Key points
- An HPLC method with ELSD was validated for measuring polysorbate 80 in therapeutic monoclonal antibodies.
- The method was reported to quantify PS80 accurately from 0.05 to 0.5 mg/mL.
- Robustness testing found tolerance for up to 160 mg/mL mAb interference using dilution or protein precipitation.
- The authors say the method can be used for release and quality control testing of PS80.
Disclosure
- Research title:
- Validated HPLC method measures polysorbate 80 in mAbs
- Authors:
- Xiaojuan Yu, F. Wang, Chuanfei Yu, Lan Wang
- Institutions:
- National Institutes for Food and Drug Control
- Publication date:
- 2026-02-25
- OpenAlex record:
- View
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