Bioanalytical method development for monoclonal antibodies: advances and challenges

Monoclonal antibodies (mAbs) represent a cornerstone of modern therapeutic strategies, targeting a wide array of diseases with unprecedented specificity. Developing and validating bioanalytical methods for mAbs are critical to ensuring their efficacy, safety, and regulatory compliance. This review discusses the recent advances in bioanalytical technologies and the persistent challenges faced in the field. Significant progress has been made in chromatographic techniques, mass spectrometry, and capillary electrophoresis, enhancing the analysis of mAbs in terms of resolution, sensitivity, and throughput. Innovations such as high-resolution mass spectrometry and automated capillary electrophoresis systems have transformed the mAb characterization landscape. However, challenges remain, primarily due to the complex nature of mAbs, which necessitates the development of susceptible and specific methods to determine their pharmacokinetic profiles and detect low-abundance impurities accurately. Moreover, the stringent and evolving regulatory requirements demand robust and reproducible analytical methods. This review emphasizes the need for continuous technological innovation and adaptation to address these challenges effectively.