Poloxamer Detection Used in Applications of Gene Therapy and Delivery
Emery Pharma presented this work at the 68th American Society for Mass Spectrometry (ASMS) Conference in June, 2020. Here, in this video, we presented the overview of the method for trace-level quantitative analysis of Poloxamers in biological samples by High-Performance Liquid Chromatography Electrospray Ionization-Triple Quadrupole Mass Spectrometry (HPLC-ESI-QqQ MS). The developed method is based on a robust Liquid Chromatography Tandem Mass Spectrometry Multiple Reaction Monitoring (LC-MS/MS MRM)-based assay and a simple protein precipitation-based sample preparation protocol to address challenges with quantification of trace amounts of this polymer in a variety of biological matrices.
The analytical performance of the LC-MS/MS method, including specificity, linearity and range, accuracy, precision, and recovery, was presented and shown per FDA and ICH regulatory recommendations. The linear dynamic range extended from 2 µg/mL to 100 µg/mL with a lower limit of quantification (LLOQ) of 2 µg/mL and limit of detection (LOD) of 1 µg/mL. Various blank matrices showed endogenous interfering component levels ≤ 20% of the Poloxamer signal at the LLOQ. The most accurate results were obtained when a quadratic model was applied. The response at the LLOQ showed a %CV ≤ 20%, and the accuracy was ≤ 20%. All other non-zero calibrators exhibited accuracy and %CV ≤15%.
The validated LC-MS/MS method was used to quantitate Poloxamer levels in human serum and gene therapy-based drug products to support clinical trials, gene therapy product release, and pharmacokinetic (PK) assays. To learn more about Poloxamer quantitation and how we would be able to assist you, please contact us online or call us at +1 (510) 899-8814!
About the Author
Originally authored by Ali Najafi. This article was reviewed and updated on July 25, 2025 by Dr. Ryan Cheu, current Director of Chemistry.
