2006 Facility of the Year Award Winner!

Baxter BioPharma Solutions

Project: Phase IV Expansion
Location: Bloomington, Indiana USA
Size: Total facility 162,000 sq. ft. with 37,000 sq. ft. of Manufacturing
Cost: US $116 million

Project Information: The Bloomington facility’s Phase IV expansion is designed to provide the benefit of faster turn-around time and cost savings with large-scale syringe filling, aseptic formulation, vial filling, lyophilization, terminal sterilization, and flexible formulation capacity for a variety of challenging products such as insoluble solutions and vaccines.

Product: Pre-filled syringes and lyophilized vials

Key Project Participants:

• Process Facility Design/Build and Validation: Pharmadule AB
• Architect (non-process): Raymond Professional Group Inc.
• Construction Management: Turner Construction Company
• Equipment Suppliers: USFilter, Kemiterm Getinge, Zetterstrom, Pharmadule, INOVA, Orbitec, Carrier, Holland Heating, Voltec, Climet, Mettler Toledo

Timeline:

• 22 Months from start of Detailed Design to FDA Approval.

AstraZeneca

Project: Large Scale Laboratory (LSL)
Location: Macclesfield, UK
Size: 5990 m3
Budget: £25 million

Project Information: The LSL has been a highly successful venture between AstraZeneca and its Alliance Partners to deliver a state-of-the-art facility enabling Campaign 2 (C2) manufacture of drug substance for volunteer studies to be taken off the critical path.

Product: Volunteer study pharmaceuticals for gastrointestinal, cardiovascular, respiratory, oncology and neuroscience disorders

Key Project Participants:

• Manufacturer and Construction Manager: AstraZeneca
• Designer: Jacobs Engineering Group Inc.
• Equipment Suppliers: Thermal Transfer, Galifords, Mach-Aire, Boulting Group, Westpile, Red Architectural, Interserve, QVF, Killelea, Honeywell

Timeline:

• Sanction and Design start: October 2001
• Construction start: January 2002
• Construction complete: December 2003
• Commissioning period: May 2003 to June 2004
• Validation period: March 2003 to June 2004
• First product produced: June 2004

Daiichi Asubio Pharma Co., Ltd

Project: New Bio Plant (NBP)
Location: Gunma Prefecture, Japan
Size: 5,000 sq. m.
Cost: US $30 million (approx.)

Project Information: ASUBIO's New Bio Plant is a multi-product and multi-scale "Launch Plant" for bio bulk products adopting unique processes, making it a first in Japan. As a launch plant, new drugs will be distributed to consumers directly from the plant.

Products: Biological Bulk products – API of peptide for clinical and commercial use

Key Project Participants:

• Manufacturer: Daiichi Asubio Pharma Co., Ltd.
• Designer, Construction Manager and Commissioning and Validation Consultants: JGC Corporation
• Equipment Suppliers: Bioengineering AG (Shibuya Kogyo Co., Ltd.), GE Health Care Bio-sciences K.K. , Kyowa Vacuum Engineering Co., Ltd, Niro Soavi S.p.A, Westfalia Separator, Tanabe Willtec Inc, Nitto Rika Kogyo Co., Ltd, Yamatake Corporation, Yokogawa Electric Corporation

Timeline:

• Design start date: September 2003
• Construction start date (piling): July 2004
• Construction completion: July 2005

Janssen Pharmaceutica

Project: Small Volume Area – Powder Unit
Location: Geel, Belgium
Size: 1699.41 sq. ft.
Cost: €5.9 million

Project Information: The facility is for handling highly potent powders and is one of four separate state-of-the-art production installations comprising the High Containment Production Chain. Consistent with the so-called containment technology, these installations are fully enclosed and, as a result, substantially enhance quality and safety. The facility combines state-of-the-art milling installation and high-technology separation with the aid of glove boxes, or isolators.

Products: Fentanyl, buprenorphine, itraconazole, haloperidol

Key Project Participants:

• Manufacturer: Janssen Pharmaceutica
• Designer: Janssen Pharmaceutica Chemical Production Engineering and Central Engineering Department, and Foster Wheeler/BNS Engineering
• Equipment Suppliers: SKAN, Hosokawa Alpine, AZO, Ensysta, Promatic B

Timeline:

• Concept/Mock ups: May 2000
• Basic engineering: October 2000
• Detailed design: January 2001
• Start installation: September 2001
• Mechanical completion: April 2002
• Process start up, qualification: August 2002
• Hand over to client (start validation): August 2003
• First commercial production: April 2004

Wyeth Pharmaceuticals

Project: The Wyeth BioPharma Campus at Grange Castle
Location: Clondalkin, Dublin, Ireland
Size: 1,000,000 sq. ft.
Budget: US $1.8 billion

Project Information: This new facility was developed to meet the demand for Enbrel and Prevenar and provides strategic manufacturing capacity for all other biological projects. The result is the largest fully integrated facility ever built in single phase. The facility was designed to meet current needs and future capabilities and is capable of manufacturing bulk drug substance and fill-finishing biologics, vaccines, and antibiotics on one campus.

Products: Enbrel, Prevnar, Tygacil

Key Project Participants:

• Project Management: Wyeth Medica Ireland, Wyeth BioPharma and Wyeth Global Engineering
• Designer/Construction Manager: Jacobs Lend Lease –LLC (a joint venture between Jacobs Engineering and Bovis Lend Lease)
• Program Management Support: Arup, Atkins Faithful & Gould, Bio Pharmaceutical Consulting, Keating & Associates
• Equipment Suppliers: BOC Edwards, Bosch Gmbh, Bruns Pak, Alfa Laval, Millipore, Steris, Aqua Chem, Schneider Electric Ireland, Vivendi Water Systems, York

Timeline:

• Recommendation accepted: Late 1999
• Enbrel manufacturing license received: July 2005
• First product delivered: September 2005

Special Merit Recognition: Biolex Therapeutics

Project: Phase II Manufacturing Expansion
Location: Pittsboro, North Carolina USA
Size: 7,500 sq. ft.
Budget: US $3.7 million

Project Information: By emphasizing project simplicity, the GMP facility was completed from the beginning of design through IQ/OQ validation in only five months. Additionally, the project was delivered under budget, with no safety incidents, and with superior quality.

Products: Alpha Interferon

Key Project Participants:

• Manufacturer: Biolex, Inc.
• Designer: O’Neal Engineering, Inc.
• Construction Manager: O’Neal Constructors, LLC
• Validation: O’Neal, Inc.
• Equipment Suppliers: Controlled Environments, PureFlow, Advantage Engineering, Covington

Timeline:

• Design start date: March 16, 2005
• Construction start: May 23, 2005
• Construction completion: July 29, 2005
• Validation completion: August 15, 2005
• Date product first produced: API Bulk Released October 26, 2005