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Cell Culture Facility Design/Assist
The project’s scope encompassed the NIMO 1 manufacturing facility, a lab/office building, GMP warehouse, 3-story operations building and a central utilities building – all connected by a central personnel/material transfer spine. The manufacturing building accommodates six 15,000L scale trains for the production of bulk cell culture products. The facility supports cell culture, purification, central cleaning, bulk formulation, media and buffer prep and was designed to meet FDA GMP and EU regulatory guidelines.
The project was executed in a design/assist approach with integration efforts between CRB and local design/build contractors for completion of construction documents. CRB was responsible for complete process and process utilities design. CRB was responsible for setting the project Basis of Design for mechanical, HVAC, electrical and instrumentation and controls design and then reviewing design/build contractor adherence to the project design basis.
Over 450 P&IDs were developed for process, process utilities and HVAC. CRB produced coordinated equipment/line/valve/specialty items/instrument lists from an intelligent P&ID database.
CRB managed the efforts of four module vendors responsible for the fabrication of 17 production modules and 18 fermentor skids. This included over 70 process vessels.
CRB provided construction administration services and start-up support as an extension of the Owner’s staff.
Genentech (Formerly Biogen IDEC)