The use of biological molecules as drugs are becoming increasingly common and an essential part of the pharmacological repertoire. However, exposure to these biological molecules carries a risk of eliciting an anti-drug immune response producing anti-drug antibodies (ADAs). These ADAs may impact the function of the drug or contribute to unwanted immune responses.  Currently, characterization of anti-drug immune responses requires multiple tiered screening and confirmation steps to: a) detect and confirm the presence of anti-drug-specific antibodies, b) determine the titer of ADAs and c) evaluate ADA isotypes and drug-neutralization capacity. In this presentation, Dr. Paul Rhyne will describe how he combined all of the above mentioned ADA screening requirements into a single multiplex immunoassay for Humira® (adalimumab), a human monoclonal IgG1 antibody that binds TNFα. This immunoassay can comprehensively characterize anti-drug antibody responses in a simple overnight procedure. The multiplex immunoassay was developed on the Luminex® FLEXMAP® 3D platform to rapidly and effectively screen patient serum samples for anti-Humira® antibody activity while simultaneously characterizing and isotyping the ADAs including IgG1, IgG2, IgG3, IgG4, IgM, IgE, and IgA.