Evaluating Downstream Processing Options at the Bioprocess-business interface

The cost to patients and healthcare providers for Monoclonal Antibody (MAb) treaments has traditionally been high. The complex process required to generate, purify and formulate the drug add significantly to the overall cost. Although efforts have been made to reduce costs by looking at increasing manufacturing efficiencies e.g., selection of new chromatography sequences and strategies, this effort has been impeded by a lack of a systematic framework to assess the process-business trade-offs of competing process configurations. The goal of this project was to generate computer-based decision-support algorithms that assess the operational and business outcomes of future bioprocessing strategies for MAbs. By combining detailed process economic models, multi-objective decision analysis and combinatorial optimisation techniques with suitable methods of visualising the process-business interactions to create a powerful holistic tool for prioritising cost-effective downstream manufacturing.