Biologics and in particular monoclonal antibodies (mAbs) are an important class of therapeutics, and their market is growing. The production of mAbs is a complex and lengthy process. In-process characterisation of the mAb is needed to optimise the production steps.
Mass spectrometry (MS) is an essential technique for detailed characterisation of biomolecules but its use is limited to purified samples. However, the hyphenation of a MS system to a 2D-LC system allows for the analysis of more complex samples. The first dimension of a 2D-LC system is used to purify the sample from its matrix while the second dimension coupled to MS can be used to separate and characterise the different variants or species of the molecule. A 2D-LC/MS system installed in a full GMP environment was used to test the characterisation of a mAb in a complex mixture at the intact and sub-unit levels.