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

Monoclonal antibodies (mAbs) have revolutionized 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 and the therapy for each patient. 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. The fundamental principles, benefits, constraints, and uses of each method are analyzed, along with recent progress and forthcoming developments, in order to identify key advantages and disadvantages and provide guidance toward selecting suitable analytical methods which are fit for purpose and can suitably serve R&D and mAb manufacturing applications.