Overarching research challenge
To enhance fundamentally the way in which new biomolecules and processes are developed for manufacture and delivery to the patient.
Mode of Operation
60% of the funding is directed to two core flagship research programmes that will create, prove and disseminate decision-support tools to select the best manufacturing lifecycle pathway from the bulk agent to the final medicine for use by the patient.
- Flagship 1
Framework for rapid determination of manufacturability of bulk product and final dosage form
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.[image reference is broken]
- Flagship 2
Decision-support tool for biomanufacturing lifecycle analysis under uncertainly
As the biopharmaceutical sector matures, increasing emphasis is being placed on early identification of failures to reduce costs and promote innovation. Production costs and capacity utilisation have become critical success factors. To maintain competitive while continuing to innovate, the sector needs to design flexible and cost-effective multi-product facilities that can cope with diverse drug candidate characteristics and process variations.
This flagship research aims to:
- Generate a biomanufacturing lifecycle evaluation tool to enable the costs of manufacture, as well as the costs of treatment, to be predicted as a consequence of the decisions made during manufacture and product design.
- Establish a decision-support optimisation tool to locate the most cost-effective combination of process parameters, process sequence, formulation method and facility design whilst assessing manufacturing robustness under uncertainty.
- To develop advanced multivariate analysis tools to predict the degree of facility fit and root causes of product loss when optimal processes are transferred into existing facilities.
Developing these tools is a major undertaking and significant leverage can be exerted by integrating these approaches to provide a novel linkage between product design, process route selection, manufacturing approach and product delivery to the patient.[image reference is broken]
The remaining 40% of funding is directed to platform activities which cover research, training, networking and knowledge transfer. Platform research provides a flexible approach to building our position as the leading centre for collaborative research in the innovative manufacture of macromolecular therapies and to investigate significant new areas of process research related to biopharmaceutical manufacture.
Platform funding is available to external UK academics for feasibility studies aligned to the Centre’s strategy link and for PhD studentships through the Centre for Doctoral Training. Information on how academics outside the Centre can engage with the centre is provided in the link below.