WUERTZEN, PETER ADLER,LUND, GITTE,JACOBI, HENRIK HUGO,IPSEN, HANS-HENRIK
申请号：
CA2532726
公开号：
CA2532726C
申请日:
2004.07.28
申请国别(地区):
CA
年份:
2013
代理人:
摘要：
The invention relates to an in vitro method of evaluating the immunologicalactivity of a vaccine preparation in the form of a mixture of a molecularantigen and a carrier, wherein the mixture comprises a liquid phase and asolid phase, to which at least a part of the antigen is attached, the methodcomprising the steps of i) subjecting the vaccine to one or more measurementsselected from the group consisting of: 1) the immunological activity of themixture, 2) the immunological activity of antigen in the liquid phase, 3) theimmunological activity of antigen in the solid phase, 4) the immunologicalactivity of antigen in the liquid phase upon a treatment of the mixture todisplace the antigen from the solid phase, and 5) the immunoligical activityof antigen in the solid phase upon a treatment of the mixture to displace theantigen from the solid phase, wherein the immunological activity measurementis selected from the group consisting of antibody binding capacity using animmunoassay employing an antigen-specific antibody bound to an antibody solidphase, b) ability to activate effector cells and c) potential for inducinganaphylaxis； and ii) using the measurement results.
