Biogen Idec Finding NIMO Biotech Plant Worth $380 Million Investment

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Researched by Industrialinfo.com (Industrial Information Resources, Incorporated; Houston, Texas). Biogen Idec (NASDAQ:BIIB) (Cambridge, Massachusetts) is rushing to complete its impressive $380 million biopharmaceutical manufacturing plant near San Diego, in Oceanside, California. Despite headlines filled with the escalating woes of the life science industry, the massive five-building manufacturing center is proof that there are still companies that believe that ensuring future capacity is a risk worth taking.

Dubbed NIMO, short for the New Idec Manufacturing Operation, the project includes 500,000 square feet of building space, with over half of it dedicated to manufacturing. The first phase of NIMO will include a fermentation and purification production facility (NIMO manufacturing building 1), a combination three-story QC lab and administration building, a GMP warehouse including a central weighing/dispense area (warehouse building), a central utilities building with a connecting corridor and utilities services running to all the buildings on campus (CUB-spine building) and an operations building with office, shop and service facilities.

Designed by McGraw Baldwin, the three-story complex will feature 91 stainless steel vats connected by 47 miles of pipe and 300 miles of electrical wire. When complete in 2006, the new plant will begin production of TYSABRI (formerly known as Antegren), Biogen Idec's multiple-sclerosis (MS) drug. The general contractor for NIMO is DPR Construction Incorporated of Redwood, California.

In November 2004, Biogen Idec received approval of TYSABRI in partnership with Elan Corporation plc (NYSE:ELN ) (Dublin, Ireland). TYSABRI is the first monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsing forms of MS. The company is banking on the hope that the drug will be a blockbuster, and NIMO will ensure they can meet demand. When the plant is fully operational, Biogen Idec will have nearly 200,000 liters of biologics manufacturing capacity. Test production runs will begin later this year.

Until the NIMO plant is validated and FDA-certified, Biogen-Idec will manufacture the drug at its 250,000 square-foot plant in RTP, North Carolina. FDA approved quality-control laboratories at the Oceanside site are already fully functional and testing of drugs is underway. The NIMO site is expected to eventually employ up to 800 people.

TYSABRI is one of a new generation of drugs called monoclonal antibodies. In the body, antibodies are produced as part of the immune response, and they bind to and neutralize proteins associated with certain diseases. To produce TYSABRI, genetically engineered mouse cells spliced with human DNA components are grown and multiplied in a series of vats called bioreactors. The antibodies are then harvested from the rich cellular mix, filtered, purified and formulated.

One of the biggest threats during the manufacturing process is microscopic bugs, or microbes, which can "kill" the cell culture. To reduce this risk the manufacturing areas are made as sterile as currently possible. Doors and rooms are sealed. The air is filtered and the water is purified. Workers even wear disposable gowns and footies. Production areas include a series of "cleanrooms" that can reduce the number of contaminants to as little as 100 particles per cubic foot.

Biogen Idec has expressed hope that TYSABRI will capture as much as 50 percent of the MS market. The drug will be the most expensive of its type and will be given to MS patients each month, at a cost of about $23,500 a year, which is over 30 percent more than the next-most costly treatment, Rebif, at $17,500. In November of 2003, Idec Pharmaceuticals merged with Biogen Incorporated to become Biogen Idec and currently has 9 drugs in clinical development.

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