FOR IMMEDIATE RELEASE
(TAMPA, FLORIDA, USA, 7 November 2011) – 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:
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.
About MedImmune, LLC
MedImmune, the global biologics arm of AstraZeneca PLC operating through various affiliates in the AstraZeneca Group (LSE: AZN.L, NYSE: AZN), has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com.
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
Now in its 33rd year, INTERPHEX is the largest gathering for FDA regulated drug and drug delivery products for technical professionals in development & manufacturing for pharmaceutical, biologic, generic, contract manufacturing and supporting services. ISPE is the exclusive official association sponsor of this industry-leading annual event. Scheduled for May 1-3, 2012 at the Javits Convention Center in New York City, NY, USA, the event hosts more than 650 suppliers on the show floor along with an expanded conference program, featuring a high-profile roster of subject matter experts. For information, visit www.INTERPHEX.com/ISPE.
About Pharmaceutical Processing
Pharmaceutical Processing magazine is the pharmaceutical industry's leading information provider, reporting on a full range of innovative new products, equipment, technology and trends for 28,000 engineers and managers responsible for the development, manufacture, validation and packaging of pharmaceuticals. An official sponsor of INTERPHEX, Pharmaceutical Processing distributes critical information to these professionals in a timely manner through a full range of print, electronic and online media. For information, visit www.pharmpro.com.