Clinical Production Facility
Client:
Abgenix, Inc.
www.abgenix.com
Cost: $125,000,000
Size: 100,000 sq.ft.
Location: Fremont, California
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CRB was responsible for designing this
state-of-the-art facility which produces
biologics and biopharmaceuticals for Phase 1-3
clinical studies in cell culture expression
systems. The project involved fit-out of
approximately 100,000 sq. ft. of space within an
existing shell building. The manufacturing area
occupies approximately 60,000 sq. ft. and
contains two 12,000L scale bioreactors. The
facility also contains associated cell inoculum
seed lab, harvest/recovery suite, purification
suite and bulk filling suite. Support facilities
included raw material storage, weigh/dispense,
media preparation, buffer preparation, glass and
tank wash staging and cleaning, GMP autoclave,
clean utilities and plant utilities. The filling
suite supports both liquid and lyophilized
product in the range of 3,000 to 10,000 10mL
vials. 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).
CRB's scope included design of the following:
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 design included WFI, clean steam,
biowaste, CIP/SIP, process chilled water,
process hot water, plant utilities and specialty
gases.
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