| 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 measurement s selected from the group consisting of: 1) the immunological activity of the mixture, 2) the immunological activity of antigen in the liquid phase, 3) th e 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 immunoligical activity of antigen in the solid phase upon a treatment of the mixture to displace th e antigen from the solid phase, wherein the immunological activity measurement is selected from the group consisting of antibody binding capacity using an immunoassay employing an antigen-specific antibody bound to an antibody soli d phase, b) ability to activate effector cells and c) potential for inducing anaphylaxis; and ii) using the measurement results.
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