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Monitoring polysorbate 80 degradation in protein solutions using Total Holographic Characterization.

Tiffany Markus¹, Juliana Lumer¹, Rivka Stasavage¹

¹Spheryx Inc., 330 East 38th Street, 48J, NY, 10016, USA.

International Journal of Pharmaceutics

|January 24, 2024

Summary

Polysorbate 80 (PS80) degradation releases free fatty acids (FFA) that are hard to detect. Total Holographic Characterization (THC) can now quantify FFA particles, enabling monitoring of PS80 degradation in biologics.

Keywords:

Biopharmaceutical Characterization Degradation products Protein aggregation Stability Surfactant

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Area of Science:

Pharmaceutical Science
Analytical Chemistry
Biotechnology

Background:

Polysorbate surfactants are crucial excipients in biologic drug formulations.
Degradation of polysorbates (PS80) via oxidation or hydrolysis generates free fatty acids (FFA).
These FFA degradants form particles that are difficult to detect due to low concentrations and similar refractive indexes to buffers and other contaminants like protein aggregates.

Purpose of the Study:

To develop a method for detecting and quantifying free fatty acid (FFA) particles resulting from Polysorbate 80 (PS80) degradation.
To demonstrate the utility of Total Holographic Characterization (THC) for monitoring PS80 degradation in protein-based drug products.

Main Methods:

Characterization of oleic acid and linoleic acid (common PS80 degradation products) particles using Total Holographic Characterization (THC).
Determination of the limit of detection for oleic acid using THC.
Application of THC to monitor PS80 degradation in protein solutions containing other potential contaminants.

Main Results:

Total Holographic Characterization (THC) successfully characterized free fatty acid (FFA) particles.
THC can detect oleic acid at concentrations below 100 ng/mL.
The characteristic THC profile of oleic acid was used as a marker to quantitatively monitor PS80 degradation in protein solutions, even with interfering particles like silicone oil and protein aggregates.

Conclusions:

Total Holographic Characterization (THC) provides a sensitive and specific method for detecting and quantifying FFA particles from PS80 degradation.
THC enables quantitative monitoring of PS80 stability in biologic drug products.
This technique aids in ensuring the quality and shelf-life of pharmaceutical products by tracking critical degradation pathways.