ADA Assessment And Detection

Cell therapies are emerging and evolving as promising therapies for a variety of disease indications. The ability to detect anti-drug antibodies (ADA) is important for patients receiving cell-based therapies. However, approaches to detecting ADAs against cell-surface biotherapeutics vary utilizing either traditional ligand binding assays or cell-based binding assays. Both ADA assay approaches have been utilized but there is no current regulatory guidance on which format is more appropriate for these therapeutics. In this presentation, we will discuss the challenges of both approaches and current industry practices.