title: Multiplexed serum measurement of IgG, IgA, IgM, and IgE antibody responses to therapeutic biologicals.
abstract: Analytical methods characterizing the immunogenicity of therapeutic proteins are useful for monitoring, characterizing and predicting reactions to biopharmaceuticals. A multiplexed assay capable of isotyping the specific IgG, IgA, IgM and IgE (IgGAME) antibody responses against a biotherapeutic was demonstrated in a hyper-immunized cynomolgus monkey, over a 15-month period. The quantitative range of the antibody measurements was determined to be 15 ng/ml to 50 ng/ml in 10% serum. By the use of any biotinylated or fluorescently tagged therapeutic as a detector, this multiplexed isotyping assay can be broadly applied to human and non-human primate IgG, IgA, IgM and IgE immunogenicity studies.
authors.affiliation: BioAnalytical Research and Development, Genentech, Inc., South San Francisco, CA, USA. Krista@gene.com
authors.forename: Krista
authors.initials: K
authors.lastname: McCutcheon
authors.forename: Edward
authors.initials: E
authors.lastname: O'Hara
authors.forename: David
authors.initials: D
authors.lastname: Fei
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology; D061067:Antibodies, Monoclonal, Humanized; D000918:Antibody Specificity; D018845:CD11 Antigens / Q000276:immunology; D007114:Immunization; D007070:Immunoglobulin A / Q000097:blood; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D007132:Immunoglobulin Isotypes / Q000097:blood*; D007075:Immunoglobulin M / Q000097:blood; D008252:Macaca fascicularis / Q000097:blood*; D008863:Microspheres; D023421:Models, Animal; D011994:Recombinant Proteins / Q000276:immunology; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007132:Immunoglobulin Isotypes; D007075:Immunoglobulin M; D011994:Recombinant Proteins; D007073:Immunoglobulin E; C472181:efalizumab