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US 5,470,560 AGranted
Method for evaluating immunogenicity
AssigneeGenentech, Inc.
InventorDavid W. Martin, Jr.
Life of this patent
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Abstract
Biological effects of agents for diagnostic or therapeutic use are evaluated by administration of the agents to transgenic animals which are transformed with heterologous DNA and which are immune tolerant to the expression product of the heterologous DNA. In a further embodiment, preparations that are immunogenic in the transgenic animal model are purified by reverse immunoaffinity chromatography on antibody obtained from responding transgenic animals.
Claims9
A method for determining the immunogenicity of a potentially immunogenic polypeptide in a mouse which comprises:
- (a) providing a transgenic mouse whose somatic and germ cells contain a DNA sequence encoding a heterologous polypeptide, said DNA sequences having been introduced into said mouse or an ancestor of said mouse during an embryonic stage and said DNA sequence being transcribed and continuously expressed under the control of a promoter, whereby said mouse becomes immunologically tolerant to said heterologous polypeptide as a result of the expression of said DNA sequence;
- (b) administering to said mouse of step (a) said potentially immunogenic polypeptide, wherein the potentially immunogenic polypeptide is a variant of said heterologous polypeptide;
- and
- (c) determining the presence of antibodies specific for said potentially immunogenic polypeptide using radioimmunoassays or ELISA systems as an indication of the immunogenicity of said potentially immunogenic polypeptide.
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Dependencies are inferred from the claim text.