The biophysical characterisation of biopharmaceuticals is critical to the development of a well-controlled large-scale production process. Moreover, as patents expire, the number of biosimilar candidates is rapidly rising, and the abbreviated development pathway associated with these molecules places a heightened emphasis on biophysical characterisation as a means to prove similarity. Guillaume Tremintin and Stuart Pengelley of Bruker Daltronics suggest that the complexity of a protein´s heterogeneity profile, compared to small molecules, demands a number of complementary techniques to achieve sufficient characterisation.

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