MedImmune FMC named 2011 Facility of the Year Awards Overall Winner

MedImmune’s Frederick Manufacturing Center (FMC) expansion facility is the Overall Winner of the 2011 Facility of the Year Awards (FOYA).

Now in their seventh year, the FOYA recognise state-of-the-art pharmaceutical manufacturing projects that use new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines.

MedImmune built and licensed a flexible, large-scale mammalian cell culture-based production facility adjacent to its existing Frederick Manufacturing Center (FMC) in Maryland, US. This challenging project was delivered to a tight deadline with an outstanding safety record – more than 2.3 million man-hours without a lost-time incident. The result was a facility capable of handling a variety of product titres supported by a fully integrated Process Control System (PCS).

MedImmune’s project team used a military-inspired, four-tiered training methodology to help transition the workforce to the new facility. It supplemented the training programme with a comprehensive shakedown schedule that maximised 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. It successfully completed more than 13 shakedown runs and three PV runs without a single contamination or lost batch.

The FOYA judging panel said it 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, the US firm took the overall accolade in the FOYA.

In addition to MedImmune, six other companies were recognised. They were:

• F. Hoffmann – La Roche, won the Facility of the Year Award for Operational Excellence for its MyDose Clinical Supply Facility in Kaiseraugst, Switzerland.
• Merck & Co took the Facility Integration Award for its Global Clinical Supplies Manufacturing, Packaging, and Warehouse Expansion project in Summit, New Jersey, US.
• Novartis Vaccines and Diagnostics won the award for Equipment Innovation for its MARburg Site (MARS Project) in Marburg, Germany.
• Pfizer Health AB, took the Operational Excellence Award for its Pegasus Bio 7 Manufacturing Facility in Strängnäs, Sweden.
• Pfizer Manufacturing Deutschland won the Sustainability Award for its Strategic Plant Restructuring and Energy Master Plan (SPRING and E-MAP) project in Freiburg, Germany.
• Shire HGT was given an Honourable Mention for its Project Atlas, Building 400 project in Lexington, Massachusetts, US. ISPE announced the FOYA winners at its 2011 Annual Meeting in Grapevine, Texas.

The FOYA are sponsored by ISPE, Interphex and Pharmaceutical Processing magazine.