Monoclonal antibodies complete primary structure and biosimilarity assessment in a single analysis by sheathless capillary electrophoresis-mass spectrometry

摘要

Monoclonal antibodies (mAbs) are meeting an important success as therapeutic treatments and represent currently one of the fastest growing area in drug development. Patents on some approved mAbs are going to end giving the opportunity to produce "copies" referred as biosimilars. Regulation agencies requires for approval to demonstrate the chemical similarity between a candidate biosimilar and the original mAbs. mAbs are highly complex glycoproteins, displaying a wide range of microheterogeneities so adapted analytical techniques may be a huge asset for development/ approval of biosimilars. A sheathless CE-MS platform was used to develop a CE-ESI-MS/MS method allowing fast and robust characterization of mAb primary structure and assess biosimilarity between 2 mAbs samples.