2008 Facility Of The Year Awards (FOYA) Winners Announced
Five pharmaceutical manufacturing facilities constructed by companies located in Germany, Switzerland, and the United States have been selected as Category Winners in the fourth annual Facility of the Year Awards program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. The companies and respective award categories include:
- Boehringer Ingelheim Pharma GmbH & Co.KG, located in Biberach, Germany, winner of the Facility of the Year Award for Facility Integration
- Bristol-Meyers Squibb, located in New Brunswick, New Jersey, USA, winner of the Facility of the Year Award for Equipment Innovation
- IDT Biologika GmbH, located in Dessau-Rosslau, Germany, winner of the Facility of the Year Award for Operational Excellence
- Pfizer, located in Illertissen, Germany, winner of the Facility of the Year Award for Process Innovation
- F. Hoffmann La Roche AG, located in Basel, Switzerland, winner of the Facility of the Year Award for Project Execution
Recent enhancements to this prestigious awards program include naming winners in five specific categories. 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 fourth 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.
"It's amazing to see the consistency in quality of projects submitted year after year," said Scott Ludlum, ISPE's Director of Business Initiatives. "It was not an easy choice for the judges to choose the five winners with so many outstanding projects being submitted. I believe this indicates the commitment of the industry to build truly innovative facilities that reduce costs and improve operational efficiency," said Ludlum.
The Awards Program is truly global, as submissions over the past four years have been received from at least 20 different countries and territories.
Each of the submissions was reviewed by an independent, blue-ribbon judging panel of global representatives from the pharmaceutical design, construction, and manufacturing sectors.
Facility of the Year Award Winner in Facility Integration: Boehringer Ingelheim
To accommodate the growing number of development projects and promote the application of new technologies, Boehringer Ingelheim decided to create a new facility on its major R&D site in Biberach in the southern part of Germany. A central goal was to integrate all major functions for pharmaceutical development in one building to promote synergies, optimal communication, and seamless cooperation across the relevant disciplines. Modern and flexible GMP facilities for internationally acceptable manufacture of investigational medicinal products were required to support clinical trials phase I to IV. Planned as a development facility, maximum flexibility was of utmost importance to enable handling of a broad diversity of product types, batch sizes, potencies, and dosage forms. With a growing number of highly potent active compounds emerging from research, suitable areas were necessary for safe handling without compromising flexibility.
The solution of this variety of requirements was the construction of a new building which was commissioned in January 2006. On 9000 m² utilization area the building contains state-of-the-art formulation laboratories, pilot plants for solids and parenterals, GMP facilities, and office areas. Both building layout and the concept for technical support systems allow easy adaption to future needs and the implementation of new technologies.
Project Implementation: Boehringer Ingelheim Pharma GmbH & Co.KG, Biberach, Germany
General Planning: Henn Architekten, Munich, Germany
Facility of the Year Award Winner in Equipment Innovation: Bristol-Meyers Squibb
This innovative facility brought early and late phase clinical manufacturing and development scale-up together within a single facility to create a Pharmaceutical Development Center of excellence on the Bristol-Myers Squibb (BMS) New Brunswick, New Jersey, USA campus.
A phased approach was initiated to adapt an existing building to allow full implementation of lessons learned as containment and process automation technology was integrated into existing operation. Phase one implemented a state-of-the-art Clinical Supply Operations expansion facility, including full containment for expanded Oral Solid Dose (OSD) operations and the most flexible clinical-scale continuous barrier line in the United States for sterile products, according to a spokesperson for BMS. This highly technical facility was designed for manufacturing OSD batches up to 400Kg and parenteral liquid fill batches up to 250L. The goal was to create a flexible facility capable of performing multi-product clinical scale manufacturing and processing solvent-based and potent compound operations. The first phase consisted of approximately 93,110 sq. ft. including processing, manufacturing, support, and mechanical space.
Phase Two built upon the technologies in Phase One and added additional processing space and scale to the Oral Solid Dose clinical operation and a new stand-alone Product Technology Center for development scale-up activities. The addition to OSD Operations allows the manufacture of Long Term Stability batches within the Clinical Supply Operations facility in at least one-tenth commercial scale.
The new facilities provide BMS with the increased capacity to meet clinical demand and deliver Compliance, Productivity, and Technical Innovation to meet present and future drug development pipeline needs - ultimately helping speed products to market.
Engineering Design Firm: IPS, Inc., Lafayette Hill, Pennsylvania, USA
Construction Manager: Torcon, Inc., Red Bank, New Jersey, USA
Facility of the Year Award Winner in Operational Excellence: IDT Biologika GmbH
IDT Biologika GmbH started contract development and manufacturing activities for newly developed human viral vaccines more than 10 years ago.
In the last decade new technologies were developed based on in house development work considering the latest regulatory demands. Most challenging was safeguarding all operations in a multipurpose facility; excluding cross-contamination and expensive lead time between manufacturing campaigns. Use of disposable technologies, room sterilisation procedures, as well as transparency of operations and process flow were major demands to comply with regulatory and client expectations.
These criteria and the operational expertise were used to design the new Facility for Production of Live Human Viral Vaccines IDT 201.
The total production area of 4.698 m² includes two contained manufacturing lines allowing segregated operations for preparation of cells, virus propagation and virus purification using highly efficient technical systems like fermentors and robotic systems. In-process control areas, offices and storage areas complement the manufacturing plant. The building was constructed within 19 months and provides capacities for development and manufacturing of vaccines for clinical trials phase I to III, as well as for commercial supply.
General Contractor: TEW GmbH, Dessau-Rosslau, Germany
Design and Construction: Heene + Pröbst GmbH, Ludwigshafen, Germany
Clean Room Systems: Daltrop and Huber, Neckartailfingen, Germany
Automation and BMS: Neuberger Building Automation, Rothenburg odT, Germany
Facility of the Year Award Winner in Process Innovation: Pfizer
Pfizer Manufacturing Deutschland GmbH at Illertissen, Germany, is a strategic site in the Pfizer Global Manufacturing network. The site is focused on OSD Forms and is a center of excellence in containment manufacturing.
Rapidly growing demands for the recently launched product Chantix and future capacity for highly potent compounds led to the decision of Pfizer Global Manufacturing to expand the existing capacity at Illertissen, Germany.
Project "NEWCON" combined all existing Site expertise and led to a novel concept in high containment manufacturing operations with the highest degree of integrated automation. All unit operations are located within a single containment module, supported by automation systems without any manual handling. The single containment module ("cell concept layout") enabled attention to be focused on sequence and flow. All equipment within the cell has been fitted with suitable barrier technology such as isolators and split valve technology. Related process control is located in an adjacent room with connection to all automation systems and levels that support processes like MES and laser guided transport vehicles. As a consequence, no operator attendance is required inside the containment suite and no Personnel Protection Equipment is required upon routine operations.
The 7800 m2 size facility became operational within a period of 25 months since start of construction.
Engineering Design Firm: PharmaConsult Inc., Heidelberg, Germany
Construction Manager: H. Saegmueller, Pfizer, Illertissen, Germany
Manufacturing Facility Build: Koppenhoefer Inc., Stuttgart-Moehringen, Germany; Jetter Inc. (Utilities), Gersthofen, Germany
Facility of the Year Award Winner in Project Execution: F. Hoffmann La Roche AG
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. To increase production capacity for its innovative cancer drugs, Roche constructed two new biotechnology production facilities - one at the Roche site in Penzberg (Germany), one of the world's largest biotechnology centers. The new plant "Biologics IV" is four stories high and consists of two highly automated production lines - each containing three 12'500 Liter fermenters and a downstreaming processing - as well as associated laboratory and office accommodation. It represents an investment of 290 Million Euro.
The construction project was run as an ultra fast track project and the new plant was designed, built and put into operation within only three years. The new facility is initially used to manufacture the active ingredient of the anti-breast cancer drug Herceptin. Roche has created about 150 new jobs to operate the new facility. Once running at full capacity, Biologics IV will enable the supply for 100,000 additional Herceptin patients per year.
Architects: Koppenhöfer & Partner GmbH
Engineering Contractor: LSMW GmbH - Total Life Science Solutions
Construction Manager: SIBC GmbH - A Turner & Townsend Company
Facility of the Year Activities in 2008 include:
There will be several opportunities to meet the 2008 Facility of the Year Award Winners and learn first-hand about the facilities being honored as "best in their class." These events include:
* INTERPHEX2008- Meet the Category Award Winners at the Facility of the Year Awards Display Area at booth number 4441 in Hall D of the Pennsylvania Convention Center. This is your 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 2008 Annual Meeting - Learn first-hand who the Overall Winner of the coveted 2008 Facility of the Year Award is during ISPE's 2008 Annual Meeting, 25-29 October 2008 in Boca Raton, Florida, USA. For more information, visit www.ispe.org .
At each event, a Facility of the Year Awards display will feature 2008 Category Award Winners. Additionally, comprehensive coverage and publicity will be conducted by ISPE and Pharmaceutical Engineering, INTERPHEX, and Pharmaceutical Processing. Visit www.facilityoftheyear.org for more information.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical manufacturing professionals in 90 countries around the globe. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore. Visit www.ispe.org for additional Society news and information.
About INTERPHEX
INTERPHEX is the world's most trusted source for leading-edge technology, education, and sourcing of the products and services that drive scientific innovation for Life Sciences Manufacturing. The INTERPHEX Conference and Exhibition is the world's largest gathering of professionals and technology providers for the pharmaceutical and biotechnology manufacturing industry, now in its 29th year. Scheduled for 26-28 March at the Philadelphia Convention Center, the INTERPHEX2008 exhibition will feature more than 1,000 exhibitors, an expanded conference program, and a high-profile roster of speakers. For information, visit www.interphex.com.
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 31,000 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 on-line media. For information, visit www.pharmpro.com.
SOURCE: ISPE and INTERPHEX