Vaccine Development
and Expansion
Client: Wyeth-Lederle Vaccines & Pediatrics
www.wyethlederle.com
Cost: $17,500,000
Size: 37,000 sq.ft.
Location: Sanford, North Carolina
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CRB was the prime A/E firm performing schematic, detailed design, and construction period services for this 13,000 sq. ft. pilot plant. The facility was designed for human vaccine development, and market launch in compliance with U.S. cGMP and European Community standards.
The facility has a fermentation suite, microbiological lab and supporting mechanical space classified as Biosafety Level 3, Large Scale CDC-NIH (BL3-LS). The facility includes support rooms for media, buffer and alcohol prep and a Class 10,000 purification suite as well as a dry formulations lab for the lyophilization and handling of viral products. Utilities include new hot WFI generation, storage and distribution, compressed air system (USP), bottled gas distribution, clean steam system, process chilled water system, biological waste decontamination system and Clean-in-Place systems. Processes include; seed bank, media preparation, fermentation, cell harvest, centrifugation and purification including ultra filtration, liquid chromatography and alcohol precipitation. The facility is designed for operating in a campaign fashion with decontamination and fumigation performed before changing hosts.
CRB was also responsible for the renovation of the existing production facility to house a development lab expansion. The new 6,500 sq. ft. space will house Nuclear Magnetic Resonance (NMR) lab, quarantined storage, analytical, fermentation, and purification labs, as well as associated support areas for product development.
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