Routine Monitoring Of DNA/mRNA Therapeutics With The Alliance™ iS Bio HPLC System And Ultra Wide-Pore GTxResolve™ Premier SEC Column

By Xiangsha Du, Robert E. Birdsall, Karen Nyholm

Gene therapy development necessitates advanced analytical technologies to enhance both efficiency and safety, particularly in quality control (QC) environments. Size exclusion chromatography (SEC) is commonly employed for characterizing and monitoring size variants in biopharmaceuticals. Though SEC is recognized as an effective technique for separating mRNA from potential aggregates, challenges like peak broadening due to system dispersion and unsuitable column particle pore sizes can hinder method development and performance. This study assesses the ability of the Alliance iS Bio HPLC System to support manufacturing labs with routine mRNA therapeutic analysis. Results demonstrate that using Waters™ ultra-wide pore particle GTxResolve Premier SEC Column, the Alliance iS Bio HPLC System performed similarly to the ACQUITY™ Premier UPLC™ System in SEC separation. Continue reading to learn about this HPLC platform suitable for the downstream analysis of DNA/mRNA therapeutics using SEC.