Journal of Pharmaceutical and Biomedical Analysis Open, cilt.6, 2025 (Scopus)
The emergence of anti-drug antibodies (ADAs) poses a significant challenge in biological therapeutics, undermining drug efficacy and patient safety. This review thoroughly assesses existing and novel analytical methods for ADA detection, highlighting their principles, strengths, and limitations. Conventional techniques like ELISA and ECL provide great sensitivity but may be inadequate for detecting low-affinity ADAs. On the other hand, surface plasmon resonance (SPR) offers advantages in detecting low-affinity anti-drug antibodies (ADAs) due to its real-time kinetic assessment. Recent advancements in label-free technologies, such as thin-film interferometry, electrolyte-gated organic field-effect transistors, and quartz crystal microbalance, show significant potential for rapid, sensitive, and real-time ADA monitoring. These advanced platforms enable accurate kinetic characterization and offer promise for point-of-care applications. Additionally, novel approaches address limitations of conventional immunoassays by simplifying workflows and reducing assay time. This review underscores the importance of ADA assessment for optimizing personalized therapeutic strategies and improving patient outcomes.