Flagship 1

Framework for rapid determination of manufacturability of bulk product and final dosage form 

Key contact

Paul Dalby 

p.dalby@ucl.ac.uk
This research flagship aims to create indices that rank macromolecular products in terms of their manufacturability as a) the bulk active drug substance and b) the final drug product in a patient dosage form.

These indices will act as early predictors of bioprocess performance. Such ranking would allow decision makers to weigh up manufacturability and product dosage form options along with their knowledge of potential clinical efficacy, to select the most promising proteins from panels of candidates, and eliminate those most likely to fail due to difficulties in bulk product manufacture and final formulation.

To achieve this the research will generate new experimental tools as well as modelling capabilities for rapid, microscale assessment and ranking of protein properties.

The research will also establish more detailed cause-and-effect models to estimate manufacturing performance (e.g. yield, purity) as functions of critical process parameters (e.g. pH) and protein properties (e.g. aggregation propensity).

This will facilitate greater process understanding and pinpoint potential processing issues.