Berlex Biopharmaceutical Plant, Snohomish County, Washington State, USA

Berlex Laboratories LLC based in Bothell, Washington is the US subsidiary of the German pharmaceutical company Schering AG. In 2004 Berlex and Schering made the decision to construct a new 95,000ft² (8,361m²) biopharmaceutical facility in north west Washington State in the Seattle metropolitan area (Lynnwood, Snohomish County).

Following this decision in August 2004 the company purchased a 16 acre (6.4ha) site in the Northpointe Corporate Center (owned by Opus Northwest LLC) for $10m. Northpointe Center is located some 17 miles (27km) north of Seattle. The centre provides infrastructure with robust fibre optic and telecommunication capacity to handle engineering, biomedical and high tech companies.

The new $60m plant has been under construction since early 2005 and is expected to be opened in the third quarter of 2007. The new facility will join a growing number of biopharmaceutical facilities in the area and will initially employ up to 180 workers.

It will then be the biggest new facility in biopharma in Washington State. Snohomish County has attracted more than 30 biotech operations; collectively, they account for about 25% of Washington State's total biotech jobs.

The facility will manufacture the new cancer drug Leukine (sargramostim). Leukine is a hematopoietic growth factor that stimulates neutrophils, monocyte/macrophages and dendritic cells, and is used in the stimulation of the immune system following prolonged treatment with chemotherapy. It is also used in the treatment of patients following bone marrow transplantation.

Berlex is also seeking approval for the drug’s use in treating Crohn’s disease, a chronic illness that causes digestive tract irritation.

SITING OF THE PLANT

Berlex has 200 employees based in Seattle and Bothell at the former Immunex Corporation plant which passed into the company in 2002 when Schering spent $380m in purchasing the Leukine operations belonging to Immunex to diversify its US healthcare business.

When Immunex merged with Amgen it spun its proven Leukine product to Berlex for full production. Berlex wanted to stay in the geographical area to make use of the personnel they already had with expertise in the manufacture of Leukine at the Puget Sound plant.

In addition the Puget Sound operation includes the oncology business unit and a clinical research team. David Carlson, Vice President for biologics manufacturing and logistics at Berlex said: "Siting the new plant elsewhere could've meant losing some of its workers who already knew how to make Leukine… A key site-selection consideration for Berlex and its parent company has been to retain our existing team of commercial biologics manufacturing professionals.

"This team provides an ideal nucleus for the global supply centre for Leukine, as well as for future biopharmaceuticals that may be developed and commercialised by the company for worldwide markets."

Snohomish County Economic Development Council has given advice and incentives to Berlex for bringing the plant to Snohomish County.

CONSTRUCTION AND OPENING

The new plant will double the US production of Leukine. Berlex has begun Phase 3 clinical studies to evaluate Leukine as a Crohn's and arthritis treatment and is gambling on its approval. The four-building Northpointe complex is expected to open in the fourth quarter of 2007, with 70 employees to manufacture Leukine on a larger scale (projections expect 180 employees at the plant by 2009).

However, if this is not possible, it may also be used for contract manufacture of other biopharmaceuticals. The complex will consist of two manufacturing buildings, a power generation building and an administration block. The main contractor for the project is Skanska USA building of Seattle.

ICON GENETICS

Icon Genetics AG has entered into a collaborative agreement with Berlex to evaluate the expression levels and quality of selected Berlex preclinical pharmaceutical proteins when expressed in transgenic plants using Icon's proprietary magnICON biomanufacturing platform technology. This provides a method for producing therapeutic and other high-value recombinant proteins using non-GMO (genetically modified organisms) non-food plants as a production host.

The technology provides for the extraordinary amplification level of the gene of interest and simultaneous shut-off of the other biosynthetic processes in the cell, resulting in the highest theoretically possible yield and relative yield of a recombinant protein in a plant cell.

The magnICON technology also allows for rapid production in a timescale of only weeks of gram quantities of recombinant proteins necessary for clinical trials, thus eliminating the major R&D bottleneck. This technology may well be used in the new Berlex plant.