Glycan Profiling of Therapeutic Antibody by Multi-attribute Method

Abstract

Glycosylation is one of the major post-translational modifications of antibodies. Certain glycans of therapeutic antibodies affect biological activities, and the glycan is one of the structural characteristics that can be a candidate critical quality attribute of therapeutic antibodies. Because the glycan structure changes depending on the type of cell substrate and culture conditions, it is required that the glycan profile be analysed in detail beginning in the early stages of development. Although a method combining fluorescent labeling and liquid chromatography is well-established as a glycan analytical method for therapeutic antibodies, a new method using high-resolution accurate mass spectrometer called multi-attribute method (MAM) has been attracted increased amounts of attention in recent years. In this review, we outline the characteristics of the glycans of therapeutic antibodies and the glycan analysis using MAM.