MedImmune Brings Home ISPE Facility of the Year Award for $250 Million Frederick Manufacturing Investment

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--Grapevine, Texas, was the venue for last week's annual meeting for the International Society of Pharmaceutical Engineering's (ISPE) (Nov. 6-9, 2011). The theme of this year's event, "Preparing Professionals and Organizations for Rapid Change," was evident throughout the week.

One of the highlights of the meeting was the announcement of the 2011 Facility of the Year (FOYA) Awards Overall Winner at the beginning of the Keynote Session on Monday morning. As always, the sessions' speakers were an impressive group, including Timothy Tyson, chairman and CEO of Aptuit Incorporated; Brett Girori, vice chancellor for strategic initiatives for the Texas A&M University System; John Menna, director of healthcare strategy for UPS; and J. David Doleski, acting supervisory consumer safety officer, Office of Manufacturing and Product Quality (OMPQ), Division of Good Manufacturing Practice Assessment for the U.S. Food & Drug Administration.

Now in its seventh year, the FOYA program is launched at the annual Interphex Conference, held earlier this year in New York, New York, March 29-31. At that time, the FOYA identifies state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. MedImmune (Gaithersburg, Maryland), the global biologics arm of AstraZeneca plc (NYSE:AZN), walked away with this year's top honors.

MedImmune initially placed under the "Project Execution" category for its $250 million investment to construct a large-scale mammalian cell culture-based production facility adjacent to its existing Frederick Manufacturing Center (FMC). A major feature of the project is that it is automated, with a fully integrated process control system (PCS), allowing for the handling of a wide variety of products.

The company employed a so-called military-inspired, four-tiered training methodology to help transition the workforce to the new facility. MedImmune supplemented the training program with a shakedown schedule that maximized practice runs prior to process validation. Simulators were used to run through commissioning and qualification, allowing the actual physical equipment to be put through shakedown runs. Parsons Corporation (Pasadena, California) and Fluor Corporation (NYSE:FLR) (Irving, Texas) worked together on the project delivery team.

There are typically six individual categories for which entries are considered. This year's program also included an honorable mention. The remainder of the nominated projects and their respective categories are listed below:

• Process Innovation: F. Hoffman - La Roche Limited: "MyDose" Clinical Supply facility in Kaiseraugst, Switzerland


• Facility Integration: Merck & Co. Incorporated: Global Clinical Supplies Manufacturing, Packaging and Warehouse Expansion, Summit, New Jersey, USA


• Equipment Innovation: Novartis Vaccines and Diagnostics GmbH: "MARS Project" (Marburg Site) facility in Marburg, Germany


• Operational Excellence: Pfizer Health AB: Project Pegasus - Bio 7 Manufacturing facility in Strängnäs, Sweden


• Sustainability: Pfizer Manufacturing Deutschland GmbH: SPRING & E-MAP (Strategic Plant Restructuring & Energy Master Plan) project in Freiburg, Germany


• Honorable Mention: Shire HGT: Project Atlas, Building 400 facility in Lexington, Massachusetts, USA

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