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.