FACILITY DESIGN CONSIDERATIONS
Because of the unpredictability of the development portfolio, two of the most important design considerations include the
need for maximum operational flexibility and the speed at which changes can be made. Because site operators will be working
with a number of processes in the course of a year, the ability to easily and quickly reconfigure operations and equipment
is vital. These two factors affect nearly all design decisions at Shanbally—from how automation is initially configured to
how buffers and media are dispensed.
The Use of Disposable Bags
Assessing project requirements was a critical initial step that covered a sweep of key factors and design and build elements
carefully mapped to Shanbally's future use. Again, speed and flexibility topped the list of requirements. Designing in the
ability for rapid changeover from one product to another meant the use of less hard piping in the facility. Instead, the project
team opted for the use of disposable bag technology for both buffer and media, where possible. This greatly reduced the amount
of piping that needs clean in place (CIP) and steam in place (SIP) treatment, which will make changeover faster and easier.
Single Downstream Processing Equipment Train
Completion of cladding and roofing in September 2008.
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The relatively small production capacity needed for clinical quantities of drug substance dictated that the facility include
two 2,500 L bioreactors and a single downstream processing equipment train. Much of the downstream equipment is mobile and
the skids can be configured to suit differing product needs.
A key factor that influenced the plans for Shanbally was the need to achieve a design similar to the company's Phase 1 and
Phase 2a pilot plant in St. Louis, MO. Because St. Louis is the focal point supporting Pfizer's biologics research and development
efforts, plant similarities will permit colleagues at the two facilities to more easily share workload, improve technology
transfer, and work to develop new technology as required. This will help ensure smooth technology transfer in the future from
the St. Louis Pfizer Global Research & Development site to Shanbally for MAb therapeutics.
Physical Design
Final construction phase of the facility with the installation of utility equipment in October 2008.
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The physical design includes a single building consisting of a manufacturing plant with a laboratory and administration block
and a warehouse block configured at each end. The laboratories include a quality control (QC) laboratory and a dedicated technical
services laboratory where process development work using small-scale bioreactors and purification equipment will take place.
The manufacturing block has a ground floor where all utilities are located. The first floor is the main cleanroom suite where
the inoculum laboratories, cell culture, harvest, purification, buffer and media prep, bulk fill, and various support activities
are located. The cleanroom suite has an interstitial area over the walk-on ceiling. The third floor contains the main heating,
ventilation, and air conditioning (HVAC) units.
Another consideration was effective planning for warehousing space that would be adequate for storage needs of the raw materials
used in manufacturing. Storage was assessed based on the inventory requirements for our products and benchmarks with other
Pfizer sites.
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