Bridging Immunogenicity Assays - Guidelines for Assay Development

Immunogenicity assessment is important in the development of biotherapeutics, such as proteins or antibodies or conjugated peptides or oligonucleotides, that induce an immune response in the body, leading to the development of anti-drug antibodies (ADAs) which can potentially threaten patient safety. Assessment of ADAs as well as neutralizing antibodies (NAbs), which may inhibit the biologic activity of the drug, form an important part of immunogenicity testing. Immunogenicity assays can be challenging due to interferences originating from the sample matrix, drug interference or target interference. This guide presents the development of bridging immunogenicity assays utilizing the Meso Scale Discovery (MSD) Assay Development Pack and MSD technology.