title: Immunogenicity: concepts/issues/concerns.
abstract: A human protein made in cell culture via recombinant DNA technology, theoretically, should not be immunogenic in humans. In practice, however, fully human proteins, partially human proteins and modified human proteins have all been shown to be immunogenic in some patients under some circumstances. The variables that contribute to the immunogenicity of therapeutic proteins and the measurement of antibodies to these proteins are discussed.
authors.affiliation: Division of Monoclonal Antibodies, CBER/FDA, Bethesda, MD, USA. kestein@erols.com
authors.forename: K E
authors.initials: KE
authors.lastname: Stein
mesh_terms: D000911:Antibodies, Monoclonal / Q000276:immunology; D001688:Biological Products / Q000276:immunology*; D006801:Humans; D015202:Protein Engineering; D011994:Recombinant Proteins / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D011994:Recombinant Proteins