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Antibodies against Erythropoietin and Other Protein‐Based Therapeutics: An Overview
Author(s) -
KROMMINGA ARNO,
SCHELLEKENS HUUB
Publication year - 2005
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1196/annals.1313.027
Subject(s) - immunogenicity , biopharmaceutical , antibody , erythropoietin , bioassay , human proteins , medicine , pharmacology , immunology , computational biology , chemistry , biology , microbiology and biotechnology , biochemistry , genetics , gene
A bstract : 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.