Direct Quantitation of Poloxamer 188 in Adeno‐Associated Virus Products Using Reversed‐Phase Chromatography With Charged Aerosol Detection

Abstract

ABSTRACTPoloxamer 188 is a commonly used excipient in formulations to protect products against mechanical stress and adsorption loss. In this work, an analytical method was developed to directly and accurately quantitate the amount of Poloxamer 188 in the drug substance of three different adeno‐associated virus (AAV) serotypes. The method is based on reversed‐phase liquid chromatography separation of virus particles from Poloxamer 188 using a charged aerosol detector and provides linearity from 5 to 200 ppm. A good assay precision and analyte recovery allows its adaptability to potentially various applications from process development support to AAV drug product release testing.