https://orcid.org/0000-0002-8137-3284
![Sample our Physical Sciences journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/110819/TOC-Subject-Sample-2021-Physical-Sciences.jpg"})
Abstract
Polysorbate (also known as “Tween”) 80 (PS80) is the most common surfactant in biopharmaceuticals. Here, we report a sensitive, and specific platform analytical method using reversed-phase high performance liquid chromatography employing a charged aerosol detector (HPLC-CAD), that offers the ability to quantitate intact PS80 and can distinguish between low recovery of PS80 and degraded PS80 by also monitoring several PS80 degradants which offers multiple improvements over various previously reported polysorbate analytical methods. The method employs protein/monoclonal antibody precipitation and is designed to be a quality control (QC) lab-friendly method. The method is distinguishable from other published methods because the quantification of the PS80 mono-esters is free from interference from known PS80 degradants. The method has demonstrated acceptable accuracy, precision, specificity, and sensitivity through qualification studies. The specificity afforded by the method allows for employment in forced degradation studies to discern kinetic information. Lastly, the method also has promising applications with other polysorbates (PS60, PS40, and all-laurate PS20) and shows acceptable performance with several types of biopharmaceutical proteins.
Graphical Abstract
Acknowledgments
The authors would like to thank Dr. Himanshu Sharma, Dr. Kaitlin Grinias, Dr. Wayne Kelley, Dr. Andreas Sophocleous, and Dr. James Colandene for their input and timely review of the manuscript.
Author contributions
The manuscript was written through the contributions of all authors. All authors have given approval for the final version of the manuscript.
Disclosure statement
The authors have declared no conflicts of interest. KC, JS, LO, TB, MW, SM, MM, and JF are employees of GSK, LLC, and may own GSK stock. KC and JS are listed inventors on U.S. Provisional Application Serial No. PU66857P, Filed on March 20, 2020 entitled “METHOD FOR DETECTING POLYSORBATES.”