151d Biologics Pilot Plant Renovation to Enhance Bioreactor and Facility Capacity and Flexibility

Jason Fletcher, Bioprocess Clinical Manufacturing and Technology, Merck and Co., Inc., WP42A-30, Sumneytown Pike, PO Box 4, West Point, PA 19486

A $7 million capital project was initiated to provide increased capacity and flexibility for a biologics pilot plant. Due to the creative use of the existing facility space, the construction of a new facility and hiring of additional staff was deferred. Facility and equipment enhancements focused on providing additional capability for scale-up of late phase clinical supplies for therapeutic proteins and vaccines. The project team was challenged by the Merck capital management committee to embrace a new project cost management process which included both “soft cost” and “hard cost” effectiveness initiatives. This renovation project within an existing Biologics Pilot Plant has doubled the building's bioreactor capacity and created a new multi-use suite with inoculum preparation, cell culture preparation, live virus processing, disposable bioreactor-based process and purification capabilities. Due to the utilization of competitive sourcing and successful project management, $0.5 million in savings was realized on the large equipment (i.e. bioreactors and fixed tank). Through careful control of scope changes and effective communication approaches, scope creep and project costs were contained and high end user satisfaction were achieved.