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Antibodies against Erythropoietin and Other Protein-Based Therapeutics: An Overview
aInstitute for Immunology, Clinical Pathology, Molecular Medicine (IPM), Hamburg, Germany bCentral Laboratory Animal Institute and Department of Innovation Studies, Utrecht University, Utrecht, the Netherlands
Address for correspondence: Arno Kromminga, Institute for Immunology, Clinical Pathology, Molecular Medicine (IPM), Lademannbogen 61, 22339 Hamburg, Germany. Voice: +49-40-53805514; fax: +49-40-53805854. arno.kromminga{at}gmx.de
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.
Key Words: antibodies • assay • erythropoietin (EPO) • immunogenicity • protein • therapeutics This article has been cited by other articles:
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