ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced during the Keynote Session at its 2011 Annual Meeting in Grapevine, Texas, USA, that MedImmune’s Frederick Manufacturing Center (FMC) Expansion Facility is the Overall Winner of the 2011 Facility of the Year Awards (FOYA) program.
Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, the Facility of the Year Awards (FOYA) program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now in its seventh year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
To enable production of forthcoming products, MedImmune chose to build and license a flexible, large-scale mammalian cell culture-based production facility adjacent to their existing Frederick Manufacturing Center (FMC) in Frederick, Maryland, USA. This complex and challenging project was delivered in an aggressive timeline with an outstanding safety record – over 2.3 million man-hours without a lost-time incident. The result was a facility capable of handling a wide variety of product titers supported by a fully integrated Process Control System (PCS).
MedImmune implemented innovative strategies to assure project success. The project team used a military-inspired, four-tiered training methodology to help transition the workforce to the new facility. The team supplemented the training program with a comprehensive shakedown schedule that maximized practice runs prior to process validation. The team also developed a simulator that enabled them to execute commissioning and qualification of the PCS offline, freeing up physical equipment for shakedown runs. Despite the aggressive project schedule, the team successfully completed over 13 shakedown runs and three PV runs without a single contamination or lost batch.
The FOYA judging panel was impressed by the solid planning, innovative problem resolution, and fast-paced but efficient execution that allowed MedImmune to build and validate a world-class, flexible manufacturing facility with a state-of-the-art automation system. For this, MedImmune was named the 2011 Facility of the Year Awards Overall Winner.
In addition to MedImmune, the Facility of the Year Awards recognized six other companies in 2011. They were:
- F. Hoffmann – La Roche, winner of the Facility of the Year Award for Operational Excellence for their MyDose Clinical Supply Facility in Kaiseraugst, Switzerland
- Merck & Co., Inc., winner of the Facility of the Year Award for Facility Integration for their Global Clinical Supplies Manufacturing, Packaging, and Warehouse Expansion project in Summit, New Jersey, USA
- Novartis Vaccines and Diagnostics GmbH, winner of the Facility of the Year Award for Equipment Innovation for their MARburg Site (MARS Project) in Marburg, Germany
- Pfizer Health AB, winner of the Facility of the Year Award for Operational Excellence for their Pegasus – Bio 7 Manufacturing Facility in Strängnäs, Sweden
- Pfizer Manufacturing Deutschland GmbH, winner of the Facility of the Year Award for Sustainability for their Strategic Plant Restructuring and Energy Master Plan (SPRING and E-MAP) project in Freiburg, Germany
- Shire HGT, winner of the Facility of the Year Award Honorable Mention for their Project Atlas, Building 400 project in Lexington, Massachusetts, USA
More information about each of the winning projects, as well as the Facility of the Year Awards program in general, can be found at www.FacilityoftheYear.org.