The UK National Institute for Health and Care Excellence (NICE) provides national guidance and information on the use of drugs including biopharmaceuticals. They have published extensively on the issue of biosimilars, which are described in the following terms: ‘biosimilars undergo a comprehensive regulatory process which demands extensive comparability studies that demonstrate similarity to the reference medicine’. Therefore, biopharmaceuticals produced in this project must undergo careful characterisation. We will use a suite of assays to test the physicochemical and immunochemical properties of each molecule, as well as testing biological activity and purity.
Physicochemical characterisation of biosimilars is primarily achieved by high sensitivity mass spectrometry. The biological mass spec laboratory at Imperial led by Prof. Anne Dell and Dr Stuart Haslam has over 40 years of experience in the characterisation of biological molecules including recombinant pharmaceuticals, and has direct industrial experience in the design and application of precisely these types of analyses. In fact, they pioneered many of the analytical approaches used today. This experience will be applied to both the bacterial and animal cell production systems and their protein products, drawing on collaborative connections within the biopharmaceutical industry.