Anti-Drug Antibody (Immunogenicity) Testing
Immunogenicity is the ability of a particular substance, such as an antigen, to provoke an immune response in the body of a human or animal. Although this immune response is natural, the formation of anti-drug antibodies in a patient being treated with a protein therapeutic can have deleterious effects by neutralizing the effectiveness of the drug, altering its pharmacokinetics or, more seriously, attacking an autologous protein critical to normal physiologic functioning. As a result of this phenomenon regulatory agencies require immunogenicity screening for all protein drugs being submitted for regulatory approval.