Finalists named for Pharmaceutical Industry Facility of the Year award

Six pharmaceutical manufacturing facilities located in Belgium, Ireland, Japan, the UK and the US have been recognised 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., Janssen Pharmaceutica, and Wyeth Pharmaceuticals - have been named finalists. The sixth company, Biolex Therapeutics, was selected for special merit recognition. The winner of the 2006 Facility of the Year Award will be announced in March at the Interphex Conference and Exhibition in New York City.

  Now in its second year, the Facility of the Year Award competition 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. This year's Facility of the Year Award promotes technological innovation across the industry.

AstraZeneca's facility in Macclesfield, UK, was chosen for its Large Scale Laboratory (LSL) Project. The LSL has been a 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, this 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.

Baxter BioPharma Solutions' Bloomington, IN, USA facility was selected as a finalist for its Phase IV vial and syringe filling project. Baxter offers a complete spectrum of integrated, proprietary technologies and contract services to its pharma and biotech partners. 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 in the most cost effective and expedient way possible. The benefit is faster turnaround time and cost savings. The Bloomington facility's Phase IV expansion is designed to provide that benefit with large-scale syringe filling, aseptic formulation, vial filling, lyophilisation, terminal sterilisation, and flexible formulation capacity for a variety of challenging products such as insoluble solutions and vaccines.

Daiichi Asubio Pharma Co. (ASUBIO) facility of Tokyo, Japan, has been chosen for its NBP (New Bio Plant) project. A member of the Daiichi Pharmaceutical Group, ASUBIO is focusing on the development of innovative ethical drugs through new technologies, notably in the biotechnology field. 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.

Janssen Pharmaceutica was nominated for its Facility: Small Volume Area in Geel, Belgium. The Janssen Pharmaceutica site in Geel has played a crucial role within Johnson & Johnson in producing pharmaceutically active ingredients for medicines. The facility is for handling 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.

Wyeth Pharmaceuticals was named for The Wyeth BioPharma Campus at Grange Castle project located in Dublin, Ireland. With r&d programmes focused on small molecules, vaccines, and biotechnology, Wyeth is exploring more than 60 new therapies for medical conditions such as diabetes, breast cancer, multiple sclerosis, HIV, Alzheimer's disease, and schizophrenia. 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.

Biolex Therapeutics facility located in Pittsboro, North Carolina, US, has been selected for special merit recognition for its Pittsboro Phase II facility expansion project. Biolex Therapeutics applies its unique drug development capabilities and expertise to commercialise complex proteins and monoclonal antibodies that until now have been impossible or very expensive to develop through traditional means. Biolex has an extensive, multi-protein strategic alliance with Centocor and collaborations with other pharmaceutical/biotech companies including Medarex, MedImmune, and OctoPlus. The company is also advancing a proprietary pipeline of product candidates including Locteron, a next-generation controlled-release form of alfa interferon. By emphasising project simplicity, the GMP facility was completed from the beginning of design through IQ/OQ validation in only five months.

'Following the success of last year's inaugural Facility of the Year Award competition, this year's 2006 submissions are proving to recognise and amplify the significance of this critical sector of the global pharmaceutical industry,' said Robert P. Best, president and ceo of ISPE.