The Decision Process for Continuous Biomanufacturing

The growing number of potential high-volume molecules being evaluated to determine a manufacturing strategy is moving companies to investigate CBM as an alternative to batch-based platforms. Faced with making this choice between a traditional fed-batch manufacturing platform and moving to a continuous/perfusion-based process, what are the sourcing decisions that must be addressed? Workshop attendees will be provided with process, equipment, and operational information to identify the KPIs for driving the sourcing decision and to create options that identify the advantages and disadvantages of moving to a CBM platform.  The Workshop will address risk identification, CBM vs. Batch-based pros/cons, COGs analysis, regulatory considerations, and the impacts on Capital Investment. Using recent ISPE publications and the new ISPE Guide for Continuous Biomanufacturing of Large Molecule Drugs as references, Attendees of this workshop will use case study examples to define key decision parameters for making go/no-go choices to implement CBM that invokes smart manufacturing, data integration, and real-time monitoring, and enhanced QbD attributes.