Downstream Processing Suite Expansion

Centocor, Inc. Location: St. Louis, Missouri Square Footage: 13,000 (7,630 renovation) Construction Cost: $18,000,000

Project Description:

CRB was responsible for designing this building expansion which produces biologics for commercial launch. The project involved a building expansion of approximately 5,400 sq. ft. of new space and renovation of 7,630 sq. ft. The manufacturing area occupies approximately 2,700 sq. ft.

The project included relocation of a buffer prep area (Class I, Div II), expansion of a buffer storage area, addition of a CIP system, pre-viral and post-viral purification, expansion of a column packing area, installation of two freezer systems area for high density storage and build-out of the interstitial and 2nd floor area to install the additional support utilities. Design and construction were phased for early completion and included the shell for a future manufacturing suite. Documentation for the project included URS, FRS and DDS drafts for the major pieces of equipment. The facility expansion was designed to meet FDA, GMP and EU regulatory guidelines and to operate at NIH Biosafety Level 1, Large Scale (BSL-1 LS). Process modeling was completed to address current and future buffer storage requirements.

CRB's scope included conceptual design, layout and detailed design of the following: architecture, process systems, process and support utilities, HVAC, electrical and control systems. CRB was also responsible for specifying all process, mechanical and electrical equipment. Utility systems addition as and modifications included WFI, biowaste, CIP, process chilled glycol, process glycol, plant utilities, and specialty gases.
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