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Oxidation of methionine residues in the Fc region of a therapeutic antibody may affect the binding of the antibody to Protein A and FcRn leading to difficulties in purification or increased clearence in vivo. For the variable regions of the antibody, oxidation may affect antigen binding or lead to increased immunogenicity. For these reasons, the…
The level of core fucosylation on therapeutic antibodies have major impact on antibody dependent cell cytotoxicity. To study the core fucosylation, Suli Liu and Li Zang at Biogen have published a method using deglycosylation by GlycINATOR, reduction of the antibody and LC-MS analysis. Using this methodology the scientist could quantify the fucosylation within 1 h, including sample…
Researchers at the University of Geneva led by Davy Guillarme has used a novel form of HPLC column, based on wide-pore hybrid silica bonded with amide ligand, and developed an HILIC analytical workflow for characterization of biopharmaceuticals. The scientists used FabRICATOR to fragment trastuzumab to subunits and studied the fragments using the new column with HILIC separation.…
The production of antibody-based therapeutics requires careful monitoring of quality attributes. Researchers at Amgen developed a technology to model and monitor the high-mannose content of the antibody in real-time using FabRICATOR digestion (Zupke et al. 2015).
The production of antibody-based therapeutics requires careful monitoring of quality attributes. Researchers at Institute Pasteur in collaboration with LFB Biotechnologies have used FabRICATOR to monitor important quality attributes of a therapeutic antibody, directly on the cell culture supernatant (Henninot et al. 2015).