Top International Pharmaceutical Manufacturing Facilities to Be Honore

Top International Pharmaceutical Manufacturing Facilities to Be Honored as Finalists for the Inaugural Facility of the Year Award at INTERPHEX2005; Finalists Will Discuss How Their Successful Facilities Streamline Production and Reduce Costs

    Pharmaceutical Writers/Business Editors/Health/Medical
    Writers/Biotech Writers
    Interphex 2005

    NEW YORK--(BUSINESS WIRE)--April 7, 2005--Five world-class pharmaceutical manufacturing facilities from Canada, Denmark, Japan, the UK, and the US will be honored as finalists for the inaugural Facility of the Year Award during INTERPHEX2005. The Facility of the Year Award finalists will receive special recognition during the INTERPHEX conference and exhibition to be held at the Jacob K. Javits Convention Center in New York City from April 26-28. The Facility of the Year Award is sponsored by ISPE, the leading international not-for-profit society for pharmaceutical manufacturing professionals, as well as INTERPHEX and Pharmaceutical Processing magazine. This distinguished award was created to acknowledge global leaders that have demonstrated tremendous levels of quality and creativity in facility design to address the challenges facing the pharmaceutical industry today. The innovative technologies used in designing these newly constructed and retrofitted facilities have significantly increased quality, production, and safety of medicines, while decreasing costs. The five finalist projects were selected from a field of 28 outstanding global entries from Asia, Europe, North America and South America. An international blue-ribbon panel of judges representing the pharmaceutical design, construction and manufacturing sectors reviewed the entries.
    Finalists will be recognized in the Special Events Hall before the Keynote Session on Tuesday, April 26 at 8:45 am. The winner will be announced and presented with the Facility of the Year Award prior to the Keynote session in the Special Events Hall on Wednesday, April 27 at 8:45 am. Additional information about the Facility of the Year Award and a schedule of related activities taking place at INTERPHEX can be found at www.facilityoftheyear.org. Specific information about INTERPHEX can be found at www.interphex.com.
    Facility of the Year Award finalists will exhibit schematics, photographs, and presentations about their facilities in the Facility of the Year Display in the Facilities Resource Center located in Lower Level Hall 1A throughout INTERPHEX. A media briefing will be held on Tuesday, April 26 at 11:00 am. During the briefing, Bob Best, President and CEO of ISPE; John Stuttard, VP for INTERPHEX; and Tim Canny, Publisher of Pharmaceutical Processing will make opening statements, and the Facility of the Year Award winner and finalists will be available to discuss their winning projects in detail. The Facility of the Year Award will be displayed in the Crystal Palace of the Jacob K. Javits Convention Center during INTERPHEX.

    2005 Facility of the Year Award Finalists

--	Alkermes, Inc. of Cambridge, Massachusetts, US was selected for its Alkermes Brickyard Square Facility in historic Chelsea, Massachusetts. Alkermes breathed new life into a vacant cluster of four century-old brick buildings by constructing a full-scale commercial plant for the utilization of Alkermes' patented AIR(TM) technology, a pulmonary drug delivery system for multiple products including inhaled insulin. Alkermes successfully managed an integrated project team for the design, construction, commissioning and validation of the facility. The team created and executed a fast-track design/build plan incorporating future build-outs without disrupting the ongoing operation. The facility is fully compliant with current Good Manufacturing Practices requirements.
--	Apotex, Inc. of Toronto, Ontario, Canada is the largest Canadian-owned pharmaceutical company and was chosen for its Etobicoke Expansion Project. To meet rising demand for products, Apotex expanded production capacity of its facility from one billion to five billion doses annually in less than three years. Cross-functional teams executed an efficient modular approach for the 500,000 square feet of expansion and retrofitting, allowing pieces of the expansion to be finished as modules and then integrating each module into the operation of the existing facility. These teams looked outside the pharmaceutical industry for technologies to help boost productivity, ensure product quality, and improve worker safety. For example, information gleaned from the automotive industry helped the team design automated materials handling systems, and research into catalogue and Internet merchants offered valuable information for streamlining distribution and warehousing.
--	Kowa Company, Ltd. of Nagoya, Japan, was named a finalist for its Kowa Nagoya Project (new lines in Building H). Designed to accommodate increased production of its oral solid dosage products, the Kowa facility complies with all US, European and Japanese Good Manufacturing Practices. The new plant has enabled Kowa to expand its total annual production to two billion dosage units. Showcasing the first application of Lhoest manufacturing design concepts in Asia, the plant incorporates innovations such as Elveco-type docking stations, gravity-flow, advanced containment systems, automated materials handling, and full segregation of personnel and airflows to eliminate contamination. Production islands and the gravity-flow materials handling system enabled a compact design for the production rooms. As a result, clean floor space accounts for only 28% of the plant's total, in contrast to 57% in the pre-existing plant. The resultant energy savings helped Kowa significantly reduce its HVAC operating costs in Building H.
--	Lundbeck Pharmaceuticals Ltd., the UK subsidiary of H. Lundbeck A/S of Denmark, was selected for its Lundbeck Pharmaceuticals API Manufacturing Facility - P7 at Seal Sands, Middlesborough, UK. This new bulk pharmaceutical manufacturing facility uses state-of-the-art simulated moving bed (SMB) chromatography to separate the active ingredient in Lundbeck's anti-depressant drug, Cipralex(R). SMB is the only technology capable of separating compounds on a continuous industrial scale. The facility was built as a fast-track project requiring the project managers to foster a creative and flexible approach. The design is based on a skid-mounted modular principle, which reduces the time for on-site fabrication and equipment installation and is flexible for future expansion. The team employed an integrated approach to commissioning and qualification using the ISPE publications Commissioning and Qualification Baseline(R) Guide and GAMP(R) 4 Guide for Validation of Automated Systems for Pharmaceutical Manufacture.
--	Novo Nordisk A/S of Denmark was named a finalist for its new NovoSeven(R) Facility. The facility is dedicated to the exclusive manufacture of the company's NovoSeven(R) hemophilia drug. Built as a fast-track project in 18 months using modular engineering, the expandable design has increased production capacity by 100% to meet an undefined demand for the NovoSeven(R) drug to treat hemophilia and to accommodate future indications as approved. The facility consists of four separate structures with different functions including a classified production area, utility area, energy center, and administration building. Designed to provide a safe and positive working experience for employees, glass corridors connect each section and provide cohesion among the different plant functions.

    About ISPE

    Celebrating its 25th anniversary this year, ISPE is a worldwide not-for-profit Society serving nearly 23,000 pharmaceutical manufacturing professionals in 80 countries. ISPE provides Members with a community in which to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. With worldwide headquarters in Tampa, Florida and European headquarters in Brussels, Belgium, ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by facilitating the creation and dissemination of industry knowledge. www.ispe.org

    About INTERPHEX

    In its 26th year, INTERPHEX, the world's largest and most comprehensive pharmaceutical conference and exhibition, will boast a record number of exhibitors at the Jacob K. Javits Convention Center in New York from April 26-28. It is presented by Reed Exhibitions. Approximately 950 leading global companies serving pharmaceutical and biotechnical industries will showcase the latest lines of equipment, technologies and services in the areas of PharmaManufacturing, PharmaSourcing & Services, PharmaIT and in the new PharmaFacilities area. The INTERPHEX exhibition will be paired with an innovative application-oriented conference program created to help pharmaceutical and biotechnical professionals develop critical skills to increase on-the-job performance. www.interphex.com

    About Pharmaceutical Processing

    The official magazine of INTERPHEX, Pharmaceutical Processing is in its 21st year of publication. Pharmaceutical Processing maintains the largest audited reach of pharmaceutical and biopharmaceutical professionals involved in the development, manufacturing, packaging and validation processes. The monthly publication reports on regulatory issues, news on industry trends as well as new technology for the pharmaceutical, biopharmaceutical, and diagnostic manufacturing marketplace. www.pharmpro.com

    About Reed Exhibitions

    Reed Exhibitions, which manages more than 430 trade shows annually worldwide, is a member of the Reed Elsevier Group plc (NYSE:RUK)(NYSE:ENL), a world-leading provider of information-driven services and solutions. Reed Exhibitions offers integrated market access programs covering exhibitions, trade publications, direct marketing and the Internet to a database of 3.5 million in North America. Reed has North American offices in Norwalk, CT, Newton, MA, Palm Beach, FL, Las Vegas, NV and Toronto, ONT (Canada) and sales and operations offices worldwide.

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KEYWORD: NEW YORK DENMARK JAPAN UNITED KINGDOM INTERNATIONAL CANADA ASIA PACIFIC EUROPE TRACK INDUSTRY KEYWORD: MANUFACTURING PHARMACEUTICAL BIOTECHNOLOGY REAL ESTATE BUILDING/CONSTRUCTION TRADESHOW SOURCE: Reed Exhibitions

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