Antibody-mediated side effects of recombinant proteins.

This brief review is focused on the unwanted clinical effects mediated by antibodies against genetechnologically produced drugs. While many antibodies binding biotech-drugs may not be harmful, others may have deleterious clinical effects exposing patients to high risks. These antibodies can cause either lack of efficacy or hypersensitivity reactions. Examples for antibody-mediated lack of efficacy are inhibitors in hemophiliacs treated with Factor VIII, evidence of decreasing therapeutic efficacy of beta-interferons in MS-patients and pure red cell aplasia (PRCA) in patients with chronic renal failure treated with erythropoietin. Antibody-mediated hypersensitivity reactions have to be expected with all recombinant proteins. The mechanisms and causes of antibody production against biotech-drugs in patients are discussed.