(177) Effect of ionizable lipid source on the quality attributes of siRNA lipid nanoparticle therapeutics
Introduction: The quality of lipid components is crucial for the successful development of siRNA lipid nanoparticle (siRNA-LNP) therapeutics (1). This study examines how the vendor source and purity of D-Lin-MC3-DMA (MC3), a commonly used ionizable lipid, impact the critical quality attributes (CQAs) of siRNA-LNPs with a composition similar to the model drug Onpattro®. The findings offer a better scientific understanding on the effects of MC3 quality on the efficacy and safety profile of siRNA-LNPs and provide valuable insights to facilitate the development of generic formulations.
Learning Objectives:
Understand the CQAs of siRNA-LNP drugs and analytical tools for their characterization.
Learn about the purity evaluation of lipids by LC-MS method.
Analyze the implications of lipid source variability on siRNA-LNP efficacy and safety.
