Immunogenicity is the ability of an antigen to induce a humoral or cell-mediated immune response. Almost all therapeutic proteins induce some level of antibody (humoral) response for which biopharmaceutical developers need to be vigilant. Anti-drug immune responses can induce life-threatening clinical events including anaphylaxis, cytokine release syndrome, infusion reactions, non-acute reactions, and cross reactivity to endogenous proteins with implications on drug safety. Additionally, anti-drug immune responses can alter the pharmacokinetics and/or pharmacodynamics of an administered drug and therefore interfere with drug efficacy.
Alliance Pharma’s Biopharmaceutical Department can provide immunogenicity studies for anti-drug antibody (ADA) measurements from samples in conjunction with other relevant assays such as ligand binding pharmacokinetic assays. In the event that subjects are developing ADA in response to a therapeutic, these assays can provide insight into whether the ADA present is neutralizing or non-neutralizing, as well as the potential impact on drug activity. ADA to specific protein therapies are detected through ligand binding assays performed using the Meso Scale Discovery (MSD) platform. A thorough multistep process is used to identify the presence of ADA which includes an initial screening assay, a confirmation assay to determine the true positive samples, and a titration assay to quantify the relative levels in each true positive.