Abstract

The Biopharm Process Research group is the first step on the route from newly discovered biotherapeutic drugs to a commercial product which can be administered to a patient. It is the group’s responsibility to screen candidate molecules for their developability, process fit and identify a suitable commercial cell line for their production. A key output from the group is the identification of Critical Quality Attributes (CQAs). These are chemical, physical or biological attributes of a molecule, or the system that produces it, which can be defined and monitored to ensure a product is within acceptable quality limits.

This is an open-ended project in which the student is free to use novel strategies to analyse numerical and spectral datasets characterizing our molecules predicted attributes, and their intrinsic and in-process stability derived from techniques such as high performance chromatography, bio-layer interferometry and mass spectrometry. Using this analysis we plan to rapidly screen for CQAs and streamline our approach to CQA experimental characterization, whilst also uncovering uses for our datasets which hitherto remain unknown.