Comparison of Endotoxin Test Methods for SARS-CoV-2 Vaccine(Vero Cell),Inactivated
Objective To provide technical support and theoretical basis for bacterial endotoxin test and quality control of SARS-CoV-2 Vaccine(Vero Cell),Inactivated.Methods The concentration of endotoxin in the bulk and final products of SARS-CoV-2 Vaccine(Vero Cell),Inactivated was determined and compared by the gel-clot method and photometric assays[including kinetic turbidimetric assay(TKA)and micro-kinetic chromogenic assay(mKCA)].Results The endotoxin concentration of test samples determined by the above three methods were all in line with the regulations,with the endotoxin concentration in bulk not higher than 5 EU/600 SU,and that in final products not higher than 5 EU per dose.TKA and mKCA could all realize the qualitative and quantitative test,and the amount of tachypleus amebocyte lysate(TAL)used by mKCA was less.Conclusion The mKCA is the most suitable for endotoxin concentration test of the vaccine,it has the characteristics of high sensitivity,strong stability,little amount of TAL used,it can also meet the requirements of data integrity and traceability,and reduce the human-operation errors.
severe acute respiratory syndrome coronavirus 2inactivated vaccineVero cellendotoxinmicro-kinetic chromogenic assay
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