| 摘要 |
The invention relates to An in vitro method of evaluating the immunological activity of a vaccine preparation in the form of a mixture of a molecular antigen and a carrier, wherein the mixture comprises a liquid phase and a solid phase, to which at least a part of the antigen is attached, the method comprising the steps of i) subjecting the vaccine to one or more measurements selected from the group consisting of: 1) the immunological activity of the mixture, 2) the immunological activity of antigen in the liquid phase, 3) the immunological activity of antigen in the solid phase, 4) the immunological activity of antigen in the liquid phase upon a treatment of the mixture to displace the antigen from the solid phase, and 5) the immunological activity of antigen in the solid phase upon a treatment of the mixture to displace the antigen from the solid phase, wherein the immunological activity measurement is selected from the group consisting of a) antibody binding capacity using an immunoassay employing an antigen-specific antibody bound to an antibody solid phase, b) ability to activate effector cells and c) potential for inducing anaphylaxis; and ii) using the measurement results to evaluate the immunological activity of the vaccine.
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