Small-Scale Cell Culture Facility Design

Cook Pharmica, LLC. Location: Bloomington, Indiana Square Footage: 140,000 Construction Cost: $75,000,000

Project Description:

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 project involved fit-out of approximately 140,000 sq. ft. of space within an existing shell building. 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 Biosafety Level 1, Large Scale (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 client's 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. A modular clean room approach was used which included the HVAC for the clean rooms.

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