The application of mass spectrometry approaches to support the design, manufacture and characterisation of biotherapeutics

Teesside University and the Centre for Process Innovation (CPI) have entered in to a new collaboration on the application of mass spectrometry approaches to support the design, manufacture and characterisation of biotherapeutics.

This project is supported through the Catapult Researchers in Residence Programme funded by Engineering and Physical Sciences Research Councils (EPSRC).

The pharmaceutical industry has seen a dramatic shift in emphasis from the production of small molecule, chemically based drug targets to therapeutics which are manufactured using biologically based processes. These biological products include vaccines, blood components, allergenics, somatic cells, tissues and recombinant therapeutic proteins.

Seven of the top ten drugs manufactured world-wide are therapeutic proteins. Unlike their chemical predecessors these biologically sourced products present significant challenges in structural confirmation, manufacture and measurement of reactivity due to the natural structural variations which may occur during their biological synthesis.

The development of advanced measurement science approaches forms an integral component of any design, manufacturing and characterisation pipeline. Of these modern approaches the development of mass spectrometry has been of central importance.

This project aims to optimise the current use of mass spectrometry approaches and to develop and utilise recently developed techniques such as ion mobility mass spectrometry which adds an additional shape-selective dimension to the mass spectrometry experiments allowing three dimensional information to be obtained at high sensitivity.