Establishment and validation of a universal test method in vitro for SARS-CoV-2 mRNA vaccine potency

VernacularTitle:SARS-CoV-2 mRNA疫苗通用体外生物学活性检测方法的建立及验证
Author: WANG Xinzhu
Publication Type:Journal Article
Keywords: SARS-CoV-2; mRNA vaccine; Potency in vitro; Enzyme-linked immunosorbent assay(ELISA)
From: Chinese Journal of Biologicals 2024;37(3):322-328
CountryChina
Language:Chinese
Abstract: Objective To establish and verify a universal and stable potency test method in vitro for SARS-CoV-2 mRNA vaccine,so as to use it for the quality control of SARS-CoV-2 mRNA vaccine.Methods ELISA kits that could bind well to S protein of SARS-CoV-2 variants,as well as transfected cells,cell plating concentrations and doses for transfection were screened,and then a potency test method for SARS-CoV-2 mRNA vaccine in vitro was established and verified.Results An ELISA kit was found with good binding ability to S protein of each variant,and HEK293T cells were determined as the transfection cells,with the plating concentration of 2.5 × 10~5 cells/mL and the transfection dose of 4 μg/well in the 6-well plate.An universal and stable potency test method for SARS-CoV-2 mRNA vaccine in vitro was established.The verification results showed that the method met the quality control needs.Conclusion The established potency test method in vitro for SARS-CoV-2 mRNA vaccine has good relative accuracy,linearity,intermediate precision and range,and can be applied to the quality control of SARS-CoV-2 mRNA vaccines.