Facility of the Year Awards

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BAXTER BIOPHARMA SOLUTIONS (BPS) NAMED 2006 FACILITY OF THE YEAR AWARD WINNER

Award Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing Magazine

NEW YORK, New York, USA 22 March 2006 Baxter BioPharma Solutions (BPS) was named 2006 Facility of the Year Award winner during today’s plenary session of the INTERPHEX 2006 Conference and Exhibition at the Jacob K. Javits Convention Center in New York City, USA. BPS was chosen for its Phase IV Vial and Syringe Filling Project in Bloomington, Indiana, USA. Commissioned in mid-2005, the Phase IV facility is the company’s response to a market opportunity to provide large-scale syringe filling, aseptic formulation, vial filling, lyophilization, terminal sterilization, and flexible formulation capacity for a variety of challenging products such as insoluble solutions and vaccines.

The manufacturing portion of the facility was a design/build project provided by Pharmadule AB, a provider of modular facilities for the pharmaceutical and biopharmaceutical industry.

An international judging panel of experts from the pharmaceutical design, construction, and manufacturing sectors reviewed all entries and selected Baxter from among four other finalists : AstraZeneca in Macclesfield, UK; Daiichi Asubio Pharma Co., Ltd. in Tokyo, Japan; Janssen Pharmaceutica in Geel, Belgium; and Wyeth Pharmaceuticals in Dublin, Ireland.

A sixth company—Biolex Therapeutics located in Pittsboro, NC, USA- was selected for special merit recognition.

Baxter BioPharma Solutions (BPS)

The Bloomington facility is a full service contract manufacturing plant providing form, fill, and finish services to the pharmaceutical industry for a variety of sterile product dosage forms. These products include solutions, suspensions, and freeze-dried powders encompassing human and veterinary small molecule, biologic, biotech, vaccine, and protein pharmaceuticals. BPS wanted to ensure its facility’s capabilities could meet client production needs with the growing market preference for pre-filled syringes.

As the winner of the 2006 Facility of the Year Award, Baxter BioPharma Solutions (BPS) has demonstrated world-class quality with its Phase IV Vial and Syringe Filling Project.

“With its new Phase IV operation, BPS in conjunction with design/build partner Pharmadule AB, has demonstrated true leadership in the rapidly growing contract manufacturing sector,” said Peter Bigelow, Chairman of the 2006 Facility of the Year judging panel. “It is rare to find such an impressive array of cutting-edge filling technologies all within one facility. We were also very impressed with BPS’s use of bolt-on removable components, 3-D design throughout, and the combination of innovative technology and practical functionality – a difficult balance for an aseptic environment. These are among the many qualities that make this a truly world-class facility.”

The Phase IV Project consisted of partial demolition and renovation of an existing building as well as new construction, and was completed in only 22 months from start of detailed design to US FDA approval. The project combines conventional construction for administrative areas with state-of-the-art modular construction for manufacturing areas. Additionally, another off-site building was renovated for expansion of packaging operations, and BPS added large-scale cold storage capacity for temperature sensitive products.

Filling a Need

As pharmaceutical companies become increasingly focused on the R&D pipeline and its impact on sales and marketing, contract manufacturing is becoming a cost-effective alternative to large capital projects -- especially if production volumes don’t warrant the investment. BPS recognizes a need to provide these services all “under one roof,” a need that had previously been unmet by other contract manufacturers.

For consumers, pre-filled syringes have advantages over traditional packaging in vials, including reduced microbial contamination risk due to less manipulation and exact dosing for greater patient safety and compliance.

Leading the Way in Parenteral Contract Services

As the 2006 Facility of the Year Award winner, the Phase IV Project is the realization of BPS’ vision to provide contract manufacturing services for pre-filled syringes and lyophilized vials. Through a creative and innovative mix of conventional construction for support areas combined with state-of-the-art modular construction of the manufacturing areas, the project has propelled BPS to become the world's largest supplier of pre-filled syringes - with a greatly expanded capacity for delivering the unit dosage forms that are critical for vaccines being re-developed without preservatives. As a result, Baxter has a total capability of filling up to 300 million 1- to 3-mL syringes each year including automated inspection, labeling, and packaging.

About the Facility of the Year Award
Sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine, the Facility of the Year Award is the first global competition of its kind to recognize the talent and creativity required to manufacture pharmaceuticals safely and efficiently. The Facility of the Year Award is an annual event focused on newly constructed state-of-the-art pharmaceutical projects. By recognizing those manufacturers who are using new technologies both to improve the quality of their products and to reduce the cost of producing medicines, the award seeks to promote technological innovation across the industry.

The 2007 Facility of the Year Award will expand its scope to recognize various project categories in the pharmaceutical industry. Please visit the website for upcoming information about these exciting new enhancements.

Submission information and applications for the 2007 Facility of the Year Award are now available from ISPE. For more information, visit www.facilityoftheyear.org, or contact Scott Ludlum, ISPE Director of Business Initiatives, at tel: +1-813-960-2105(US) or e-mail: sludlum@ispe.org.

About

Baxter BioPharma Solutions is a fully integrated pharmaceutical contract service business with state-of-the-art manufacturing facilities in Bloomington, Indiana. Manufacturing on both clinical and commercial scales, the company can produce human and veterinary products encompassing small molecule, biologic, vaccine, and protein pharmaceuticals. Baxter BioPharma Solutions also provides a variety of sterile product dosage forms, including solutions, dispersed systems, and freeze-dried powders. Baxter BioPharma Solutions can provide you with analytical and microbiological services as well as validation and regulatory assistance. http://www.baxterbiopharmasolutions.com/

Pharmadule AB, headquartered in Nacka, Sweden, has been designing and implementing licensed modular production facilities for the pharmaceutical and biotech industries since 1986. Pharmadule offers a unique combination of process and validation experience from the pharmaceutical industry, efficient project management and high quality craftsmanship. http://www.pharmadule.com

About ISPE
Recently celebrating its 25 th anniversary, ISPE is a worldwide not-for-profit Society serving more than 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.

About INTERPHEX
The INTERPHEX Conference and Exhibition is the world's largest gathering of professionals and technology providers for the pharmaceutical manufacturing industry, now in its 27 th year. Scheduled for March 21-23 at the Jacob K. Javits Convention Center, the 2006 exhibition will feature more than 950 exhibitors, a targeted conference program, and a high-profile roster of keynote speakers. INTERPHEX is the world's most trusted source for insight into issues, education, products and services, with a wealth of innovative strategies and solutions for company and project success. INTERPHEX is a program of Reed Exhibitions, the world's leading organizer of trade and consumer exhibitions with a portfolio of more than 430 events in 32 countries. Learn more about INTERPHEX at http://www.interphex.com

About Pharmaceutical Processing
The official magazine of INTERPHEX, Pharmaceutical Processing is in its 22 nd year of publication. Reaching a total of 31,000 pharma and biopharmaceutical professionals within North America, Pharmaceutical Processing reports on new applications, services, systems and products, as well as the latest trends for engineers and managers involved in the development, manufacturing, validation and packaging of pharmaceuticals and biopharmaceutical products.

 


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