Two-dimensional LC/MS is a powerful tool to speed up mAbs and ADCs development
4th June 2020
Two-dimensional LC/MS is a powerful tool to speed up mAbs and ADCs development. It presents a number of advantages, several of which are critical in a regulated environment. Using 2D-LC/MS, it is now possible to get high-resolution MS data from non-MS compatible LC separations in a fully automated workflow. It is simple to set up a semiautomated, generic approach that matches the need of a large range of first-dimension separations, which guarantees not only its versatility, but also its robustness, reproducibility, accuracy, and method transferability. Compared to off-line methods, it is much less time and resource consuming, and guarantees an excellent traceability of results. Thanks to its performance and versatility, 2D-LC/MS can be used all along the drug life, from development to manufacturing to release and stability testing, giving access to a wider, and more in-depth range of information.
Since our paper published in LCGC in 2016, we’ve been continuing our research in applying two-dimensional liquid chromatography with high-resolution mass spectrometry in a GMP environment.
We focused on the following fields:
- Implementation of multiple heart-cutting 2D-LC/MS with at-column dilution technology
- Analysis of in-process samples: Product characterisation in complex in-process samples without sample pre-treatment
- Quantification of free drug in ADCs for batch release and during stability studies
- Optimisation of data processing, using a single 21 CFR Part 11 software solution for both acquisition and data processing, to ensure data integrity and full GMP compliance