Process Analytical Technologies (PAT) for Accurate Quantification of Monoclonal Antibodies (mAbs)

Monoclonal antibodies (mAbs) have revolutionised the biopharmaceutical industry, offering a wide range of uses in diagnostics, therapeutics, and research. Precise determination of mAb concentration is essential for guaranteeing the quality, effectiveness, and safety of the product. This review article presents a thorough examination of different analytical methods used to quantify mAbs, including chromatography, spectroscopy, immunoassays, infrared (IR) and mass (MS) spectrometry, and biosensors. We analyse the fundamental principles, benefits, constraints, and uses of each method, along with recent progress and forthcoming developments, in order to identify key advantages and disadvantages and provide guidance towards selecting suitable analytics so as to serve R&D and mAb manufacturing applications.