Multiple Heartcut 2D-LC/MS: a powerful tool for biopharma analysis in a regulated environment

Dr Arnaud Delobel, R&D Director
Dublin, Ireland

Applications of Multiple-heartcut 2D-LC/MS at Quality Assistance:

  • Characterisation of monoclonal antibodies

  • Characterisation of ADCs : 
    Hydrophobic Interaction Chromatography (HIC) is a method of choice for the characterisation of ADCs. Due to high salt content in mobile phase, it is impossible to hyphenate the chromatography to MS for peak identification. Fraction collection and desalting is time-consuming and is not easily amenable to low concentration species (due to dilution effects)

  • Quantification of free drugs in ADCs:
    Quantification of free drug in ADCs is critical for batch release and during stability studies. Cytotoxic payloads are extremely toxic and low limit of quantifications should be achieved. MS is often required to reach low LOQ, and the protein has to be removed (offline or online) before the analysis. 2D-LC/MS is a way to meet all those criteria

  • Analysis of in-process samples (work in progress)