Phase II Workpackages

WP1 Laboratory-scale continuous process capabilities to support end-to-end manufacturing Continuous processing at laboratory scale is an important target for CMAC offering a range of benefits including use of less material, improved process understanding, rapid process development, enabling research with a broader range of solvents and API. A suite of continuous platforms is being developed alongside the experimental infrastructure to accelerate process development. These platforms will support specific continuous synthesis, work-up, crystallisation, isolation and secondary processing operations.

WP2 Tools and workflows for rapid product assessment and continuous process selection We will develop rapid methodologies for assessing the physical properties of molecules, particles, formulated products and their physical transformation to inform future process and platform selection (e.g. batch vs.continuous, MSMPR vs COBR). By exploiting a comprehensive suite of automation, characterisation and measurement tools, and the developing CMAC informatics infrastructure we will deliver a robust foundation for systematic, rapid continuous crystallisation development including a crystallisation classification approach.

WP3 Product-process archetypes that support supply chains of the future The widespread adoption of continuous manufacturing and crystallisation processes in pharmaceutical industrial practice is not solely dependent upon the technical requirements of each process step. For such technologies to become more generally accepted the business case and impact on current industry supply chain configurations needs to be understood. This workpackage is focussed on addressing these issues and providing an informed view of the combinations of product and process attributes that would benefit from continuous manufacturing and the potential impact on future supply chain configurations.

Associated with these core activities, the Centre will also:
• Deliver the UK RPIF funded national facility, delivering the equipment and characterisation infrastructure to support the Centre’s Manufacturing Research Programme.
• Grow our capabilities in modelling continuous processing of API and product.
• Continue to build collaborations across the Centre, leveraging outputs of current projects through coordinated integration of projects. Currently the Centre has 45 active research projects.