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European Biopharmaceutical Review

Enhancing Analysis

Monoclonal antibodies (mAbs) are a prominent class of protein biotherapeutics because they have demonstrated outstanding efficacy in the treatment of both acute and chronic disease, with several targeted mAb drugs reaching ‘blockbuster’ status in recent years (1). This uptake is due to their many advantages over traditional small molecules, including high specificity, favourable toxicity profile, and long serum half-life (2). However, mAbs are known to form aggregates, either during fermentation, product purification, in storage, or through mishandling prior to patient administration. The formation of mAb aggregates can jeopardise both the efficacy and safety of biotherapeutics in the clinic. Specifically, the aggregation of mAb monomers to dimers, trimers, or higher order structures can be problematic for two key reasons:

• Aggregates can cause a decrease in product efficiency by lowering its effective concentration

• Aggregation can expose normally unexposed epitopes, which lead to increased immunogenicity

For high molecular weight species (HMWS) of aggregates, the primary concern is their potential to increase product immunogenicity, while low molecular weight species (LMWS) can have decreased activity or a reduced serum half-life due to missing crystallisable (Fc) regions or antigen-binding (Fab) fragments (3). Therefore, monitoring aggregate formation throughout the production process is essential to ensure the safety and efficacy of the mAb and to gain regulatory approval.

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Dr Amy Farell is the applications development team leader at the the National Institute for Bioprocessing Research and Training (NIBRT).

Dr Sara Carillo completed her PhD in chemical sciences in 2013 at the University of Naples Federico 2, Italy. She focused on the structural characterisation of polysaccharides and glyco-conjugates from gramnegative bacteria. In 2015, Sara joined Dr Jonathan Bones’ research group at the NIBRT, working on the understanding of the effects of extractables and leachables from single-use bioreactors on Chinese hamster ovary cells N-glycome. She is now working at the NIBRT in collaboration with Thermo Fisher Scientific for the development of new analytical approaches in biopharmaceuticals.

Dr Jonathan Bones received his PhD in analytical chemistry from Dublin City University, Ireland, in 2007. He then moved to the NIBRT within the GlycoScience Laboratory. In 2010, Jonathan was appointed the John Hatsopoulos Research Scholar within the Barnett Institute of Chemical and Biological Analysis at Northeastern University, Boston, before returning to NIBRT in 2012 to become the Principal Investigator of the NIBRT Characterisation and Comparability Laboratory and an Associate Professor at the School of Chemical and Bioprocess Engineering at University College Dublin.
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Dr Amy Farell
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Sara Carillo
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Dr Jonathan Bones
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