Finalists for pharma-industry facility-of-the-year award
Tampa, FL — The 27th Interphex Conference and Exhibition is claimed to be the worldwide pharmaceutical-manufacturing industry’s largest gathering of professionals and technology providers. At the conference, six pharmaceutical manufacturing sites—in Belgium, Ireland, Japan, the United Kingdom, and the United States—have been selected for recognition in the second annual Facility of the Year Award competition sponsored by ISPE, Interphex, and Pharmaceutical Processing magazine. Five of the companies—AstraZeneca, Baxter BioPharma Solutions, Daiichi Asubio Pharma Co., Ltd., Janssen Pharmaceutica, and Wyeth Pharmaceuticals—are the finalists. Biolex Therapeutics was selected for special merit recognition. The winner of the 2006 Facility of the Year Award competition will be announced March 22 at the Interphex Conference and Exhibition in New York City.
An international panel representing the pharmaceutical design, construction and manufacturing sectors reviewed each of the submissions. “These judges have expressed great interest in highlighting facilities that demonstrate innovation and technology in the pharmaceutical industry and recognizing their outstanding accomplishments,” said Peter Bigelow, judging panel chair and senior vice president, Consumer Healthcare Manufacturing, Wyeth Pharmaceuticals.
AstraZeneca (Macclesfield, U.K.) was chosen for its large scale laboratory (LSL) project. LSL has been a highly successful venture between AstraZeneca and its alliance partners to deliver a state-of-the-art facility enabling Campaign 2 (C2) manufacture of drug substance for volunteer studies to be taken off the critical path. In addition to being able to satisfy patients’ needs sooner, it represents a significant business advantage for each successful compound produced. Additionally, the asset provides an optimum range of manufacturing technologies at differing scales in a creative layout. Process streams are rapidly configurable and have novel, yet simple, containment options to suit the compound being processed, without compromising operability.
Jacobs Engineering Group Inc. provided engineering and services for the project, with particular emphasis on architectural, containment, and process engineering in the early phases.
Baxter BioPharma Solutions (Bloomington, IN) was selected as a finalist for its Phase IV vial-and-syringe filling project. Baxter identified a need to provide fast and flexible contract services to respond to changing demands and market pressures on pharmaceutical companies to get products to market at the most cost effective and expedient way possible. The benefit is faster turn-around time and cost savings. Phase IV expansion is designed to provide that benefit with 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 of Pharamadule AB, a provider of modular facilities for the pharmaceutical and biopharmaceutical industry.
Daiichi Asubio Pharma Co., Ltd. (Daiichi Pharmaceutical Group subsidiary, Tokyo, Japan) has been chosen for its NBP (new bio plant) project. ASUBIO performs R&D in support of the company's technologies to be applied in the production of proteins and peptides, as well as in its mass production capabilities. Asubio’s NBP is a multi-product and multi-scale "launch plant" for bio bulk products adopting unique processes, making it a first in Japan. As a launch plant, new drugs will be distributed to consumers directly from the plant.
JGC Corp. was awarded the contract for the engineering and construction of NBP.
Janssen Pharmaceutica (Geel, Belgium) was nominated for its Facility: Small Volume Area. The facility handles highly potent powders and is one of four separate state-of-the-art production installations comprising the high containment production chain. Consistent with the so-called containment technology, these installations are fully enclosed and, as a result, substantially enhance quality and safety. The facility combines state-of-the-art milling installation and high-technology separation with the aid of glove boxes, or isolators.
Engineering for this project was provided by Janssen Chemical Production Engineering.
Wyeth Pharmaceuticals (Dublin, Ireland) was named for its BioPharma Campus at Grange Castle project. This new facility was developed to meet the demand for Enbrel and Prevenar and provides strategic manufacturing capacity for all other biological projects. The result is the largest fully integrated facility ever built in single phase. The facility was designed to meet current needs and future capabilities and is capable of manufacturing bulk drug substance and fill-finishing biologics, vaccines, and antibiotics on one campus.
Jacobs Lend Lease is a joint venture between Jacobs Engineering and Bovis Lend Lease and was awarded the design/construction-manger contract for the project.
Special merit recognition:
Biolex Therapeutics (Pittsboro, NC) has been selected for its Phase II facility expansion project. By emphasizing project simplicity, the GMP facility was completed from the beginning of design through IQ/OQ validation in only five months. Additionally, the project was delivered under budget, with no safety incidents, and with superior quality.
O’Neal Inc. was contracted as the engineering design and construction firm for the project. It specializes in design and planning, programming, validation for cGMP facilities
— Richard Phelps , senior editor, Control Engineering