Routine Monitoring of DNA/mRNA Therapeutics With the Alliance™ iS Bio HPLC System and Ultra Wide-Pore GTxResolve™ Premier SEC Column

The development of gene therapy, especially in quality control (QC) environments, requires modern analytical technologies to improve efficiency and safety. Size exclusion chromatography (SEC) is a prevalent method used for the characterization and monitoring of size variants in biopharmaceuticals. While size exclusion chromatography is considered one of the most effective methods for the separation of mRNA from its potential aggregates, challenges such as peak broadening, caused by system dispersion, and inadequate pore size of the column particles can impede method development and reduce performance. In this study, the Alliance iS Bio HPLC System was evaluated on its ability to support manufacturing labs in the routine analysis of mRNA therapeutics. In summary, when using Waters™ ultra-wide pore particle GTxResolve Premier SEC Column, the lower system dispersion of the Alliance iS Bio HPLC System offers comparable performance to the ACQUITY™ Premier UPLC™ System in SEC separation and is an ideal HPLC platform for downstream analysis of DNA/mRNA therapeutics using size exclusion chromatography.

Benefits
- Lower system dispersion of the Alliance iS Bio HPLC System offers improved SEC performance for efficient method development and migration
- GTxResolve Premier SEC Columns offer high resolution SEC separations to support DNA/mRNA analysis in QC environments
- Alliance iS Bio HPLC System provides consistent and reliable performance for routine monitoring of impurities in DNA/mRNA therapeutics