(T1330-06-34) LC-MS/MS Method for the Quantitation of Each Monoclonal Antibody (from a 6-Components Antibody Cocktail Drug Product) in Human Serum Matrix

Purpose: In modern therapeutics, the accurate quantitation of monoclonal antibodies (mAbs) within complex biological matrices is paramount for ensuring therapeutic efficacy and patient safety. As such, the development of robust analytical methods capable of precisely measuring individual mAb components within multi-component drug products is of utmost importance. We present a cutting-edge liquid chromatography-multiple reaction monitoring-mass spectrometry (LC-MRM-MS)-based method combined with trypsin digestion meticulously designed for the quantitative analysis of each mAb from a six-component antibody cocktail drug product in human serum matrix using a single workflow.

Methods: The developed approach involves trypsin digestion of each mAb and quantification using a surrogate peptide via LC-MRM-MS analysis.

Results: Our method successfully quantifies each mAb from the six-component antibody cocktail drug product. It exhibits selectivity, specificity, accuracy, linearity, and a limit of quantitation (LOQ) of approximately 0.1 µg/mL -10.3 µg/mL at a signal-to-noise ratio of 10.

Conclusion: This method represents a valuable tool for the bioanalysis of biotherapeutics, particularly useful for drug products containing multiple active pharmaceutical ingredients (APIs). Its single workflow offers both cost-effectiveness and time efficiency.

Acknowledgements: This study was done by Emery Pharma (CRO) and was funded by Client Sponsor

Overall Workflow Using Bottom-Up Approach

Single LC-MRM-MS Workflow to Capture All Six mAbs


Key Parameters Evaluated