Abstract:
:Accurate measurement and functional characterization of antibody Fc domain N-linked glycans is critical to successful biosimilar development. Here, we describe the application of methods to accurately quantify and characterize the N-linked glycans of 2 IgG1 biosimilars with effector function activity, and show the potential pitfalls of using assays with insufficient resolution. Accurate glycan assessment was combined with glycan enrichment using lectin chromatography or production with glycosylation inhibitors to produce enriched pools of key glycan species for subsequent assessment in cell-based antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity effector function assays. This work highlights the challenges of developing high-quality biosimilar candidates and the need for modern biotechnology capabilities. These results show that high-quality analytics, combined with sensitive cell-based assays to study in vivo mechanisms of action, is an essential part of biosimilar development.
journal_name
MAbsjournal_title
mAbsauthors
Brady LJ,Velayudhan J,Visone DB,Daugherty KC,Bartron JL,Coon M,Cornwall C,Hinckley PJ,Connell-Crowley Ldoi
10.1080/19420862.2015.1016692subject
Has Abstractpub_date
2015-01-01 00:00:00pages
562-70issue
3eissn
1942-0862issn
1942-0870journal_volume
7pub_type
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