This biopharmaceutical design-build manufacturing project included the de-construction of seven specific manufacturing areas totaling over 100,000-sq.-ft. The scope included rebuilding the seed train bioreactor suite with the inclusion of N-1 perfusion equipment, reducing equipment downtime through the de-bottlenecking of CIP distribution and the addition of a new CIP skid, implementation of new process analytics to reduce process sampling requirements, and additional harvest capacity to handle the increase in cell mass.
The re-construction effort resulted in the procurement and installation of nine new vessels, 14 process skids, more than 1,000 sanitary diaphragm valves and 1,500 process instruments. This effort was completed within a three-month shutdown schedule that also included time for commissioning services. Declared the largest shutdown Biogen has ever undertaken within an existing facility, detailed collaboration and planning from DPR, CRB, IPS and all trade partners started 18 months prior to the shutdown. The collaboration resulted in a design which was phased to allow early release of the long lead procurement packages for the equipment, valves and instruments.
In addition, a comprehensive schedule and execution plan remedied the challenge of a very large scope and limited time to complete the project. The advanced planning and collaboration resulted in a safe and successful 24/7 execution which took place in 12 hour shifts over 14 weeks resulting in delivery of the manufacturing facility on-time and with no disruptions to Biogen’s production timeline.
ENR’s Best of the Best Projects (2017)
ENR Southeast Safety Awards (2017)
ENR Southeast Best Projects (2017)