Analytical methods for preclinical stage gene therapy programs

Using a process confirmation vector, researchers developed and optimized a size exclusion chromatography (SEC) with UV and multi-angle light scattering (MALS) method to measure the level of empty capsids during manufacturing. In a new study, the researchers showed that SEC-MALS outperformed other analytical methods and correlated well with sedimentation velocity analytical ultracentrifugation (SV-AUC) values of full-to-empty particles. The study is published in the peer-reviewed journal Human Gene Therapy.