Detection of anti-drug antibodies during monoclonal antibody drug therapy

Therapeutic monoclonal antibodies can elicit anti-drug antibodies (ADAs) in patients, which impact drug pharmacokinetics, reduce efficacy, and occasionally cause hypersensitivity reactions. Growing evidence indicates that early detection of ADA responses improves therapy outcomes, yet their monitoring has remained underappreciated. Conventional assays are complex, time-consuming, and confined to centralized laboratories, thereby delaying clinical decisions. In contrast, emerging biosensor technologies represent a promising alternative for timely, on-site ADA detection. This review examines advancements in ADA detection and provides a critical overview of its clinical relevance based on contemporary findings. Furthermore, the challenges and complexities of accurately biosensing ADAs are discussed. Finally, we explore the prospects of biosensors for on-site analysis and their integration into proactive therapeutic drug monitoring.