Flexible Volume Manufacturing Project

Biogen Idec Location: Research Triangle Park, North Carolina Square Footage: 10,000 Construction Cost: 18,000,000
CRB was selected to develop a Conceptual and Detailed Design for a flexible, single-use disposables manufacturing area to support pre-clinical/Phase 1 clinical manufacturing. Process operations were designed to utilize 100% single-use closed process systems,from cell culture through purification. Designed to be fully upgradeable to ISO 7 and ISO 8 classified spaces, the facility demonstrates that closed systems can be maintained through the entire manufacturing process.
The 10,000 sq. ft. FVM facility was constructed from former warehouse space and subdivided into three main suites (one Cell Culture and two Purification) with provision for future build-out of necessary support spaces,including air locks, bottling rooms,inoculum prep, waste handling and a cleaning area. Process unit operations include bioreactors, harvest filtration,chromatography, viral filtration and ultrafiltration.Intended for multi-product use, the cell culture suite is designed to handle up to 2000L single-use bioreactors.In purification, ceiling-mounted utility columns allow the process equipment to be arranged in a variety of ways depending on the process demands.
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