This just in from ISPE 2007 Facility of the Year Awards Winners Announced Five pharmaceutical manufacturing facilities located in China, Germany, Japan, and the United States have been selected as Category Winners in the third annual Facility of the Year Awards competition sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. New enhancements to this years awards program include naming winners in five specific categories. The companies and respective award categories include: ¢ Cook Pharmica, LLC, located in Bloomington, Indiana, USA, selected as winner of the Facility of the Year Award for Facility Integration ¢ Genentech located in Oceanside, California, USA, selected as winner of the Facility of the Year Award for Project Execution ¢ Shanghai Roche Pharmaceuticals, Ltd., located in Shanghai, China, selected as winner of the Facility of the Year Award for Project Execution Regional Excellence ¢ Taiyo Pharmaceutical Industry Co., Ltd., located in Takayama City, Japan, selected as winner of the Facility of the Year Award for Equipment Innovation ¢ Vetter Pharma-Fertigung GmbH & Co. KG located in Ravensburg, Germany, selected as winner of the Facility of the Year Award for Process Innovation The Facility of the Year Awards (FOYA) competition 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 third 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. There is something truly remarkable and innovative about every single submission, said Scott Ludlum, ISPE's Director of Business Initiatives. The five Category Winners hail from four different countries. This diversity demonstrates that the Awards program is a true reflection of the global nature of the pharmaceutical manufacturing industry, said Ludlum. Each of the submissions was reviewed by an independent, blue-ribbon judging panel of global representatives from the pharmaceutical design, construction, and manufacturing sectors. The addition of Category Winners to the 2007 Awards program significantly improved the competition and effectively enabled the judges to properly acknowledge those facilities that stood out and deserve special recognition, stated Andy Skibo, 2007 Judging Panel Chair, and Vice President Corporate Engineering and Capital Projects for Amgen. Those Category Winners are: Facility of the Year Award Winner in Facility Integration: Cook Pharmica, LLC The growing trend in cell culture-based therapeutics inspired Cook Group, Inc., to transform an abandoned factory into an innovative new contract manufacturing facility. The result was Cook Pharmicas Project Phoenix facility located in Bloomington, Indiana, USA. Cook Pharmica is currently focused on mammalian cell culture-based production of Active Pharmaceutical Ingredients (API). In addition to its manufacturing train offering scale-up capabilities to 5,000L, Cook Pharmica also provides contract development and analytical services. Project Phoenix (Phase 1) included the renovation and construction within the first of two buildings that were the former home of the worlds largest television assembly plant. The renovation and construction of 124,000 square feet, includes office areas, a manufacturing train, a shell for a second manufacturing train, development laboratories, quality control laboratories, warehouse, and process utilities, designed to support up to two manufacturing trains. Construction on the abandoned television assembly plant was completed in 10 months. With the footprint available for future expansion already in place and a second, independent building of 450,000 square feet, Cook Pharmicas facility is poised to expand with clients project needs. Engineering Design Firm: CRB Consulting Engineers, Inc., St. Louis, Missouri, USA Construction Manager: R.L. Turner Corporation, Zionsville, Indiana, USA Manufacturing Facility Design/Build: AES Clean Technology, Inc., Montgomeryville, Pennsylvania, USA Facility of the Year Award Winner in Project Execution: Genentech Genentechs Oceanside Product Operations (NIMO) project is located in Oceanside, California, USA. Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Upon U.S. Food and Drug Administration (FDA) licensure, which is expected in the first half of 2007, the facility will have 90,000 liters of capacity for the production of Avastin® (bevacizumab), a therapeutic antibody for the treatment of various forms of cancer. The six-building, 500,000-square-foot, master-planned campus features manufacturing, laboratory/office space, a warehouse, central utilities, and a spine inter-connecting space. The Oceanside Product Operations facility currently employs approximately 580 people. A team consisting of the owner, engineering company, architect, and general contractor was formed and developed an innovative project delivery approach that is best described as Design-Build Hybrid. Civil, architectural, and structural work were executed design-bid-build, and mechanical, electrical, process, and instrumentation and controls (I&C) were completed design-build under the management of the general contractor. In order to achieve consistency in project standards and quality, the owner, architect and general contractor all unanimously selected an engineering company to oversee all engineering performed by the design-build subcontractors in the mechanical, electrical, process, and I&C engineering disciplines. Largely due to this Design-Build Hybrid approach and people -oriented execution focus, the team delivered the base project on time and under budget. Architect/Designer: Ferguson Pape Baldwin Architects, San Diego, California, USA Engineering: Clark, Richardson & Biskup Consulting Engineers, Inc., Carlsbad, California, USA General Contractor: DPR Construction, Inc., San Diego, California, USA Facility of the Year Award Winner in Project Execution Regional Excellence: Shanghai Roche Pharmaceuticals Limited Shanghai Roche Pharmaceuticals Limited is a successful joint venture together with Sunve Pharmaceuticals of Shanghai, China, and was started in 1994. The Shanghai High Potent Production Project (SHiP) was based on a modest budget and the entire project comprised construction of a new building for the production of highly active medicines with strict containment. The facility was created to manufacture tablets and capsules for the China market, and export of products for the prevention of organ rejection in transplant recipients and for the treatment of specific forms of cancer. The focus of SHiP from conception to reality was about speed, innovation, and global teamwork. The result was achieved in a short timeframe “ only two years from last approval of the funds to commercial production. The facility respects the highest standards for environmental safety. It was built using global and local resources that now manufactures key strategic products for the local market and for export. The rapid growth in production of Cellcept and Xeloda exemplify this success. Project Management and Start-up: Shanghai Roche Pharmaceuticals Limited Architect and Construction Manager: Meissnert & Wurst Zander (Shanghai) Limited Facility of the Year Award Winner in Equipment Innovation: Taiyo Pharmaceutical Industry Co., Ltd. Taiyo Pharmaceutical Industry Co., Ltd., is located in Takayama City, Japan, and has its main business consisting of two major enterprises: contractual production for external parties, and the production of generic products. Consistent with its low cost strategy and in accordance with its mid- to long-term management strategy, Taiyo Pharmaceutical Industry Co., Ltd. began the in-house project of manufacturing pre-filled syringes (PFS) at its Unit Factory Building PFS Manufacturing facility. The project currently produces a total of six products, including four plastic syringe containers and two glass syringe containers. In addition to the in-house syringe project, two other manufacturing lines have been successfully completed and produce pre-filled syringes equipped with high-speed type isolators. The most important aspects of the services we provide to customers and markets are the provision of high quality products ¦and the stable supply of products. Our products are low in price, easy for nurses to use and create little burden on patients. This includes pre-filled syringe preparations in various doses, which reduces the risk of contamination by foreign substances, and ease of use. Designer “ Production Facilities: Horiuchi Architectural Associates Designer “ Production Equipment: Taiyo Pharmaceutical Industry Co., Ltd. Construction Management: Kashima Construction K.K. Facility of the Year Award Winner in Process Innovation: Vetter Pharma-Fertigung GmbH & Co. KG Vetter Pharma-Fertigung GmbH & Co. KGs New Facility Ravensburg Vetter South (RVS) is located in Ravensburg, Germany. Vetter is a contract manufacturer specializing in the aseptic filling of liquid and lyophilized drugs for international biotechnology and pharmaceutical companies. The New Facility Ravensburg Vetter South took 36 months from start of detailed design to complete validation. Vetter started operation of the facility in October 2006 and its production site currently has two filling lines, which will be expanded to four in the near future. The facility is the result of more than a quarter of a century of expertise in prefilling. Automation was planned throughout the building, from door openers, to the use of the brand new Restricted Access Barrier System (RABS) on the filling lines. It features maximum automation; high standards of sterility, safety, and quality; self-sufficient production site with its own utility and power supply; unique production lines; and a capacity of 90 million units per year. RVS was designed to meet all of the challenges that technicians and scientists are faced with when aseptically filling syringes, cartridges, and vials. Architect: Vetter planning team, Ravensburg, Germany Technical Building Management: Axima GmbH, Cologne, Germany Structural planning: Schneider & Partner Planungsgesellschaft mbH., Ravensburg, Germany Facility of the Year Activities in 2007 include: There will be several opportunities to meet the 2007 Facility of the Year Award Winners and learn first-hand about the facilities being honored as best in their class. These events include: ¢ INTERPHEX2007 “ Meet the Category Award Winners 24-26 April at the Facility of the Year display area located in Hall 3D, Upper Level, Jacob K. Javits Convention Center. This is the opportunity to meet personally with representatives from companies of the Category Winners to discuss the success stories associated with these pharmaceutical manufacturing facilities. To register, or for more information, visit www.interphex.com. ¢ ISPE Facilities Summit “ Learn about case studies from 2007 Category Award winners during ISPEs Facilities Summit taking place in Arlington, Virginia, from 4-7 June 2007. To register, or for more information, visit www.ispe.org. ¢ ISPE Annual Meeting “ Learn first hand who the Overall Winner of the coveted 2007 Facility of the Year Award is during ISPEs 2007 Annual Meeting taking place at Caesars Palace in Las Vegas, Nevada, USA, from 4-7 November. For more information, visit www.ispe.org. At each event, a Facility of the Year Awards display will feature 2007 Category Award Winners. Additionally, comprehensive coverage and publicity initiatives will be conducted by ISPE and Pharmaceutical Engineering, INTERPHEX, and Pharmaceutical Processing.