Chinese Journal of Biologicals 2024;37(10):1173-1178

doi:10.13200/j.cnki.cjb.004307

Comparison of domestic and imported agarose gel filtration chromatography media for separation and purification of SARS-CoV-2 Omicron vaccine

PANG Jiahui

Keywords

SARS-CoV-2; Inactivated vaccine; Agarose gel; Media; Filtration chromatography; Domestic; Imported

Country

China

Language

Chinese

Abstract

Objective To explore the separation and purification efficiency of domestic and imported agarose gel filtration chromatography media for the inactivated SARS-CoV-2 Omicron vaccine, in order to provide data support for promoting the domestic substitution of chromatography media.Methods Three batches of concentrated SARS-CoV-2 Omicron strain inactivated virus were used in the experiments, and the purification was conducted using domestic and imported agarose gel filtration chromatography media under identical experimental conditions respectively. The virus peaks were collected, and relevant quality parameters, including antigen content, protein content, residual DNA of Vero cells, residual host proteins of Vero cells, and residual bovine serum albumin content in the collected components, were measured. The specific activity and antigen recovery rates were calculated.Results After loading and purification using a 10% column volume and a linear flow rate of 30 cm/h for both media, the average antigen recovery rates for the collected components were 55. 29% and 53. 31%,respectively, with no significant difference(t = 1. 44, P > 0. 05). Moreover, there was no significant difference in specific activity, residual DNA of Vero cells and residual host proteins of Vero cells(t =-0. 25, 1. 31 and 0. 66, respectively, each P >0. 05). Only the residual bovine serum albumin content exhibited a significant difference(t =-2. 73, P < 0. 05).Conclusion The domestic and imported agarose gel filtration chromatography media were used to purify the concentrated solution of SARS-CoV-2 Omicron strain inactivated virus, and the quality parameters of the collected components had no significant difference except for the residual bovine serum albumin content. Therefore, in the purification of the inactivated SARS-CoV-2 Omicron vaccine, the domestic chromatography media could be considered as a viable alternative to imported media