Bristol-Myers Squibb, Fort Devens Elotuzumab Facility Readiness Project
Between July 2015 and September 2015, DCBA worked seven days per week, 24 hours per day with dozens of subcontractors from all over the country transform the Fort Devens Elotuzumab Facility, an occupied and operational pharmaceutical manufacturing space, from a single product line to a cell-culture facility capable of producing two product lines in parallel. DCBA performed preconstruction between December 2014 and June 2015. This process involved procurement, estimating, scheduling, creating logistics, and compiling a team to execute a tight 12-week project. Procurement efforts included working closely with BMS to develop a procurements schedule, preliminary bidders list, RFP documentation, individual RFP packages per trade, approval letters, and contracting selected subcontractors. DCBA also developed an intricate project budget (which could be filtered by phase, area/work package, CSI code, and scope of work) and finalized project-specific site logistics plans in accordance with BMS Safety, QA, and Technical Management. In preparation for construction, DCBA compiled facility access provisions and contractor/material facility access narratives that were routed through several BMS departments for comment and approval. Principles held daily meetings. Brief shutdowns were performed only to make critical utility tie-ins and all construction activities were planned and executed in compliance with BMS’S Quality Assurance Requirements. Workers installed new process equipment, including single-use mixing units, ultra-filtration pod filters, powder transfer systems, media prep TCUs, anti-foam injection systems, process agitators, tanks and vessels, caustic dilution skids, and more. Renovations necessitated tie-ins and alterations to nearly all of the in-house utilities (plant steam, clean steam, condensate, WFI, RODI, CIP, emergency/UPS/and normal power, building management systems, process gases, etc.). The project included significant amounts of high-purity process piping, which demanded careful QA/QC and productivity monitoring to ensure that systems met all cGMP manufacturing needs. By utilizing two separate shops on the East Coast, DCBA was able to have much of this work prefabricated off-site. At times, there were over 100 workers on-site, but the project was undertaken without impacting ongoing manufacturing operations, in compliance with stringent FDA/cGMP standards, and within a very compressed end-user timeframe.