Characterisation of Humira Adalimumab by high resolution mass spectrometry

Fabrice Cantais
Anicet Catrain
Eric Largy
Géry Van Vyncht
Arnaud Delobel

Due to their mode of production, monoclonal antibodies are complex and heterogeneous molecules. Their analysis usually requires the use of many orthogonal analytical techniques in order to fully characterise the different variants. In this application note, the use of mass spectrometry as a powerful tool for adalimumab characterisation is presented.

Humira® (adalimumab) is an anti-TNFα antibody approved by FDA and EMA for different inflammatory diseases, among which rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, psoriasis and Crohn’s disease. It was the best-selling product worldwide in 2014, with global sales over $13 billion.

adalimumab is a fully human recombinant antibody expressed in CHO cells. As for all proteins produced via recombinant DNA technologies, the final product is a mixture of different variants. The resulting heterogeneity has to be thoroughly characterised as it can impact the safety and efficacy of the product.

Mass spectrometry is a technique that is now widely used for biopharmaceuticals characterisation. Thanks to innovations in both hardware and software, this technique can now be used routinely. We present in this application note the use of mass spectrometry to characterise Humira® at different levels.