Therapeutic drugs may have the potential to cause an immune response in patients. As such, immunogenicity has become an important measure of the immune response to a particular therapeutic drug. During an immune response, the development of anti-drug antibodies can reduce the efficacy of a potential protein therapeutic drug and may cause allergic or anaphylactic reactions and/or induced autoimmunity.

Because of these possible immune responses, the FDA and pharmaceutical companies are making immunogenicity testing an essential part of peptide/protein drug development. Southern Research can assist clients in fulfilling this important requirement by developing and qualifying assays for the detection of anti-drug antibodies, including neutralizing antibodies. Our scientists are well-equipped to test drug candidates in animal models from mouse to nonhuman primate in order to accelerate clinical trials. In addition, we offer the capability to develop and qualify bridging assays or ELISAs for the detection of anti-drug antibodies using serum/plasma samples from clinical trials conducted at other facilities.