Validation of an HPLC-CAD Method for Determination of Lipid Content in LNP-Encapsulated COVID-19 mRNA Vaccines
Xiaojuan Yu,
Chuanfei Yu,
Xiaohong Wu,
Yu Cui,
Xiaoda Liu,
Yan Jin,
Yuhua Li,
Lan Wang
Affiliations
Xiaojuan Yu
Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 102629, China
Chuanfei Yu
Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 102629, China
Xiaohong Wu
Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 102629, China
Yu Cui
Thermo Fisher Scientific (China) Co., Ltd., Shanghai 201206, China
Xiaoda Liu
Thermo Fisher Scientific (China) Co., Ltd., Shanghai 201206, China
Yan Jin
Thermo Fisher Scientific (China) Co., Ltd., Shanghai 201206, China
Yuhua Li
Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 102629, China
Lan Wang
Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 102629, China
Lipid nanoparticles (LNPs) are widely used as delivery systems for mRNA vaccines. The stability and bilayer fluidity of LNPs are determined by the properties and contents of the various lipids used in the formulation system, and the delivery efficiency of LNPs largely depends on the lipid composition. For the quality control of such vaccines, here we developed and validated an HPLC-CAD method to identify and determine the contents of four lipids in an LNP-encapsulated COVID-19 mRNA vaccine to support lipid analysis for the development of new drugs and vaccines.
