Abstract:
Objective To identify live attenuated hepatitis A (HAV) vaccine virus seed and detect adventitious agents, monoclonal antibody is used to neutralize instead of human and rhesus monkey immune serum.
Methods Choosing suitable monoclonal antibody concentration to neutralize HAV for confirming the neutralization capacity of monoclonal antibody. To test adventitious agents after monoclonal antibody neutralized HAV vaccine virus seed, and further apply to identification test.
Results The monoclonal antibody (1:100) could neutralize 105 CCID50/ml HAV virus and it was 100 times than that of human or rhesus monkey immune serum; Applied that high efficiency monoclonal antibody to hemadsorption test and non-hemadsorption test for adventitious agents, the results were negative and the monoclonal antibody could be used in identification test.
Conclusion With high-efficiency monoclonal antibody on adventitious agents detection, it can be applied a small scale dilution of HAV virus seed to aviod the difficult of testing adventitious agents by large scale dilution of vaccine virus seed. The monoclonal antibody was used to neutralize instead of human and rhesus monkey immune serum.
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