CRB was responsible for designing and building this state-of-the-art facility which produces biologics and biopharmaceuticals for Phase 1-3 clinical studies in cell culture expression systems. The project involved fit-out of approximately 100,000 sq. ft. of space within an existing shell building. The manufacturing area occupies
approximately 60,000 sq. ft. and contains two 12,000L scale bioreactors. The facility also contains associated cell inoculum seed lab, harvest/recovery suite, purification suite and bulk filling suite.
Support facilities included raw material storage, weigh/dispense, media preparation, buffer preparation, glass and tank wash staging and cleaning, GMP autoclave, clean utilities and plant utilities. The filling suite supports both liquid and lyophilized product in the range of 3,000 to 10,000 10mL vials. The facility was designed to meet FDA, GMP and EU regulatory guidelines and to operate at NIH Biosafety Level 1, Large Scale (BSL-1 LS).
CRB's scope included design and construction of the following: process systems, process and support utilities, HVAC, electrical and control systems. CRB was also responsible for all process, mechanical and electrical equipment. Utility systems design included WFI, clean steam, biowaste, CIP/SIP, process chilled water, process hot water, plant utilities and specialty gases.
In addition, CRB provided project scheduling, conceptual estimating, value engineering and procurement. CRB also provided full construction management services during construction. Site services included general conditions, site supervision and coordination, document control, commissioning and TOP's and safety and quality control.