(27b) Future Production Plant Trend: Managing the Transition Between Single Product Operations in a Multi-Product Facility


Most biologics manufacturing plants operate on the basis of single product campaigns. In the trend of high titer mAb processes in upstream development, demand for rapid turn around during multiproduct operations is significantly increasing especially when moving to commercial production. Tools for meeting these needs have been developed at MedImmune Frederick Manufacturing Center to leverage process experience, minimize capital expenditure and increase success rate. We have mapped out the facility capacities by conducting plant water runs during the start-up, provided facility fit assessment to in-coming processes through PFD and ?Make-A-Batch? exercises and performed process justification based on DOE studies from development history and/or manufacturing data trending. Risk assessment and associated risk mitigation strategies were established. These practices lay the ground work for an efficient changeovers and successful operation, as well as shed light on the strategy for future facility expansion and introduction of disposables where appropriate.