The Study On Testing Method Of Freezed-dried Live Attenuated Hepatitis A Vaccine

Objective To optimize the testing method of key items for freezed-dried live attenuated hepatitis A vaccine virus seed and final product. (1) To identify virus seed and detect adventitious agents, monoclonal antibody is used to neutralize in stead of human and rhesus monkey immune serum. (2) The Labworks image acquisition and analysis software was used to judge the virus titer ; To establish RT-PCR-ELISA method and micro-immunofluorescence method for vaccine virus titer testing . (3) To determine the suitable method for vaccine bovine serum protein residual content testing.Method (1)Virus seed testing: To confirm the neutralization capacity of monoclonal antibody by neutralization test with monoclonal antibody and HAV vaccine virus seed. To test adventitious agents after monoclonal antibody neutralized HAV vaccine virus seed, and further applied to identification test. (2) Infective titer testing: The one-step RT-PCR method was established through the optimization such as reaction solution 's ion concentration, PH value, etc., then the half-quantitative function of Labworks image acquisition and analysis software was applied to judge the results, and the method was compared with routine cell culture method (CCID₅₀ ) ; Primer labeled with biotin was used to...