‘Military-inspired’ project wins 2011 Facility of the Year Award
pharmafile | November 9, 2011 | News story | Manufacturing and Production |Â Â MedImmune, manufacturing and productionÂ
MedImmune’s US manufacturing plant in Frederick, Maryland, has won the 2011 Facility of the Year Award, beating out rival category winners Roche, Merck & Co, Novartis, Pfizer and Shire for the overall accolade.
The annual award scheme recognises innovative pharmaceutical manufacturing projects that make use of new technologies or processes to enhance the production of quality projects, for example by reducing costs, reducing environmental impact and increasing efficiencies.
MedImmune’s Frederick site has been in operation since 1999 making the company’s monoclonal antibody product for respiratory syncytial virus, Synagis (palivizumab), although the FOYA award has been granted to a new expansion project adjacent to its existing building.
The new building, which started construction in 2005 with an initial budget of $250 million, is providing additional production capacity for Synagis and other biologics in Medimmune’s pipeline. It has been designed to handle projects a wide variety of titres thanks to an integrated process control system (PCS).
The company used a military-inspired, four-tiered training methodology to help transition the workforce to the new facility, and supplemented this with a ‘shakedown’ schedule that maximised practice runs prior to process validation.
MedImmune also developed a simulator that enabled them to execute commissioning and qualification of the PCS offline, freeing up physical equipment for practice runs. Despite the project schedule, the team completed over 13 shakedown runs and three process validation runs without a single contamination or lost batch.
Meanwhile, the facility has an outstanding safety record, running for 2.3 million man hours without a single lost-time incident.
“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”, said the organisers of the awards in a statement.
The FOYA competition is organised by the International Society of Pharmaceutical Engineering (ISPE), Interphex and Pharmaceutical Processing magazine.
The other category winners were:
– Pfizer, for its Bio 7 manufacturing plant in Strängnäs, Sweden, and SPRING & E-MAP (Strategic Plant Restructuring & Energy Master Plan) project in Freiburg;
– Roche, for its MyDose clinical supply facility in Kaiseraugst, Switzerland;
– Merck & Co for its Global Clinical Supplies Manufacturing, Packaging and Warehouse expansion project in Summit, New Jersey, US;
– Novartis for its MARS Project facility in Marburg, Germany; and
– Shire for its Project Atlas, Building 400 facility in Lexington, Massachusetts, US.
Phil Taylor
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