AVA Manufacturing Facility Design + Construction

Emergent Biosolutions Location: Lansing, Michigan Square Footage: 60,000 Construction Cost: $49,000,000

Project Description:

CRB provided turn-key design-build services for the construction of a greenfield manufacturing facility to manufacture BioThrax (anthrax vaccine). The BioThrax product involves several processing steps requiring containment for BSL2-LS sporeformer products. For flexibility, the facility was designed to meet BSL3-LS requirements and support, with minimal additional modifications, multi-product, campaign-capable microbial fermentation. 

The facility is fully cGMP and meets FDA, EU regulatory guidelines. The entire facility was designed with consideration to cleaning, decontamination, and re-commissioning requirements for product changeover associated with manufacture of multiple products on a campaign basis.

The 60,000 sq. ft. facility was designed to meet cGMP and EU regulatory requirements and includes a basement area for process waste treatment; a first floor for process utility generation and distribution systems; a second floor for media and solution preparation, fermentation, centrifuge, downstream purification, blending, and equipment sterilization; and a third floor for air handling equipment and control room operations. The second floor production space was constructed of a pre-fabricated wall and ceiling panel system, allowing for an interstitial space above the ceiling for general maintenance outside the containment area.

Process utilities include purified water, WFI, clean steam, process chilled water, clean compressed air and instrument air, full CIP systems, and clean process gases. Plant utilities include cooling tower, chillers, plant steam, heating hot water, and compressed air. Seven air handlers with related ductwork and filtration systems supply clean air to the plant. A bio-kill system is utilized to decontaminate microbial waste. Environmental rooms provide storage for work-in-progress and bulk product.

The design included prefabricated skidding of general and process utility systems including water pre-treatment, WFI/PUR water, clean steam, CIP, valve matrices, biological waste treatment systems, heating hot water, and an RO unit. A high level of instrumentation and control was included on skid mounted fermenters and centrifuge as well as the above utility equipment. The plant systems included equipment for cleaning and sterilization of production equipment and sanitary operations including sterilization and decon autoclaves, glass washer, fume hoods, and bio-safety cabinets.

Design, construction, start-up, commissioning and installation qualifications were completed in 19 months.

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