Comparison of domestic and imported agarose gel filtration chromatography media for separation and purification of SARS-CoV-2 Omicron vaccine
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 inac-tivated virus were used in the experiments,and the purification was conducted using domestic and imported agarose gel filtra-tion chromatography media under identical experimental conditions respectively.The virus peaks were collected,and rele-vant 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 anti-gen 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 ac-tivity,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.
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