Scale Cell Culture Facility
CRB was responsible for designing this state-of-the-art facility, which produces biologics and biopharmaceuticals for phase 1-3 clinical studies and small-scale production in cell culture expression systems. The manufacturing area occupies approximately 20,000 sq. ft. and contains two 2,500L scale bioreactors. The facility also contains associated cell inoculum seed lab, harvest/recovery suite, and pre-viral and post-viral purification suites. Support facilities included raw material storage, weigh/dispense, small media and buffer preparation, glass and tank wash staging and cleaning, GMP autoclave, clean utilities and plant utilities. Design makes extensive use of disposable equipment for both product and buffer operations. The facility was designed to meet FDA, GMP and EU regulatory guidelines and to operate at NIH BSL-1 LS. The building was also designed for flexibility required for contract manufacturing and for ease of expansion for either a second identical line or a larger scale process.
CRB's scope included conceptual design and layout and detailed design of both process systems and process utilities, including an overall facility master plan to address clients' forecasted product development and growth plans. CRB was also responsible for specifying all process and process utility equipment. Utility systems design included WFI, clean steam, biowaste, CIP/SIP, process chilled water, process tempered water, and specialty gases.
This project was the 2007 ISPE Facility of the Year Awards Category Winner for Facility Integration.