title: Antibodies against erythropoietin and other protein-based therapeutics: an overview.
abstract: Many factors influence the immunogenicity of protein-based therapeutics. At present, it is inconceivable to manufacture a biopharmaceutical without the risk of this adverse effect. Thus, the detection and characterization of antibodies against protein-based therapeutics is a significant task. Only clinical studies and careful monitoring of the market can be used to conclusively demonstrate rates of immunogenicity in humans for protein therapeutics. Fully validated, reliable, and robust in vitro assays, in combination with sensitive bioassays, should be used to address these topics.
authors: Institute for Immunology, Clinical Pathology, Molecular Medicine, Lademannbogen 61, 22339 Hamburg, Germany. arno.kromminga@gmx.de
authors: Arno
authors: A
authors: Kromminga
authors: Huub
authors: H
authors: Schellekens
mesh_terms: D000818:Animals; D000906:Antibodies / Q000097:blood*; D004921:Erythropoietin / Q000097:blood / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D011506:Proteins / Q000276:immunology* / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000906:Antibodies; D011506:Proteins; D004921:Erythropoietin