Sartorius Stedim BioOutsource introduces new Released N-Glycan Assay

Sartorius Stedim BioOutsource facilities in Glasgow where the new released N-Glycan assay has been developed for in-depth profiling of IgG glycosylation.

In-depth profiling of IgG glycosylation coupled with ADCC assays enables generation of robust biosimilar comparability data.

The new N-Glycan Assay is one of a range of orthogonal methods, including analysis by CD16a (FcγRIIIa) and SPR binding, as well as ADCC functional assays that BioOutsource offers to provide a detailed testing package to generate evidence suitable for regulatory submissions.

BioOutsource’s new assay involves enzymatically-removing glycans from the antibody, functionally derivatizing them and separating the glycans by UHPLC. The glycans are then identified by on-line electrospray ionization mass spectrometry (ESI-MS), enabling confident assignment and precise quantification of the different structures.

Dr Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim BioOutsource, explained: “The structural classification and monosaccharide composition of carbohydrates attached to the constant region of therapeutic biosimilar antibodies is key to their binding. An accurate understanding of these glycans ensures effective selection of biosimilars that have the optimum ADCC activity to destroy tumour cells.”

Galbraith continued: “Our new Released N-Glycan Assay coupled with our ADCC assays will help deliver this understanding by providing robust biosimilar characterization data suitable for the regulators, thus enabling efficient drug development and more rapid entry into clinical programs.”