What the study found
The study found that a high-performance liquid chromatography (HPLC) method with an evaporative light scattering detector (ELSD) can accurately measure polysorbate 80 in therapeutic monoclonal antibodies. It was validated across multiple laboratories and with different immunoglobulin G (IgG) monoclonal antibody samples and polysorbate 80 sources.
Why the authors say this matters
The authors conclude that this method can be recommended for release and quality control of polysorbate 80 concentration in therapeutic monoclonal antibodies. The study suggests this is relevant because polysorbate 80 is used to prevent aggregation and stabilize these drug products.
What the researchers tested
The researchers developed an HPLC method using ELSD for multiproduct analysis of polysorbate 80. They then validated it in several laboratories using different instruments and ELSD detectors, and tested it with various IgG monoclonal antibodies and different polysorbate 80 sources.
What worked and what didn't
The method was reported to accurately measure polysorbate 80 concentrations from 0.05 to 0.5 mg/mL. Robustness testing showed tolerance of up to 160 mg/mL monoclonal antibody interference, either by sample dilution or protein precipitation.
What to keep in mind
The abstract does not describe specific limitations beyond noting that other published methods exist and have their own limitations. No additional caveats are given in the provided summary.
Key points
- A validated HPLC-ELSD method was developed for polysorbate 80 analysis.
- Validation was done across multiple laboratories with different instruments and detectors.
- The method measured polysorbate 80 accurately from 0.05 to 0.5 mg/mL.
- It tolerated up to 160 mg/mL monoclonal antibody interference.
- The authors recommend it for release and quality control testing.
Disclosure
- Research title:
- Interlaboratory validation supports PS80 measurement in therapeutic mAbs
- Authors:
- Xiaojuan Yu, F. Wang, Chuanfei Yu, Lan Wang
- Institutions:
- National Institutes for Food and Drug Control, National Institutes for Food and Drug Control, National Institutes for Food and Drug Control, National Institutes for Food and Drug Control
- Publication date:
- 2026-02-25
- OpenAlex record:
- View
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