Considerations on pharmaceutical quality assessment and control of lipid nanoparticles of prophylactic mRNA vaccines
YANG Dan
ZHAO Xin
LI Xiao-jing
LI Min
Abstract：As the continuous in-depth research on prophylactic mRNA vaccines,new questions have been raised about lipid nanoparticles in aspects of structures and morphologies.Based on the principle of ICH Q6B,the characteristics and changes of the structures of lipid nanoparticles were preliminarily discussed from the perspective of pharmaceutical evaluation,and the additional study for the structural characteristics were also addressed for providing a reference for the quality assessment and control of prophylactic mRNA vaccines.
Keywords：mRNA vaccinelipid nanoparticleparticle sizemorphologyprocess controlquality study
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2452-2456 )