News

Posted On: 09/06/2005

FDA Licenses Amgen Manufacturing Plants in U.S. and Puerto Rico

PharmaManufacturing.com

Amgen, the world's largest biotechnology company, announced September 6 that the U.S. Food and Drug Administration (FDA) has approved the company's new manufacturing facilities in West Greenwich, R.I., and Juncos, Puerto Rico for the production of Amgen's therapeutics.

The new manufacturing plant at Amgen's Rhode Island facility has received FDA approval for the production of Enbrel (etanercept), the company's leading inflammation biologic used in the treatment of diseases such as moderate to severe rheumatoid arthritis, psoriatic arthritis and moderate to severe plaque psoriasis. Amgen's original Enbrel facility in Rhode Island received licensure in December 2002, five months after the plant was acquired by the company. Amgen has invested more than $1.1 billion to add more than 500,000 square feet to its Rhode Island campus, which now houses one of the world's largest biotechnology manufacturing facilities in terms of capacity and square footage.

Amgen's Puerto Rico facility has been licensed for commercial bulk manufacturing of Neupogen (Filgrastim), the company's product used to decrease the incidence of many types of chemotherapy-related infections and Neulasta (pegfilgrastim), Amgen's product for decreasing the incidence of neutropenic infections associated with many types of cancer chemotherapy treatments. Amgen is investing $1.2 billion to expand its Puerto Rico site, first operational in 1993.

In addition to the new manufacturing facility for Neupogen and Neulasta, Amgen is building a second Puerto Rico facility for the production of Epogen (Epoetin alfa), Amgen's anemia therapy for patients with chronic renal failure on dialysis and Aranesp (darbepoetin alfa), Amgen's latest product for the treatment of anemia associated with chronic kidney disease and chemotherapy-related anemia. The complete planned expansion at Amgen's Puerto Rico campus will double the square footage of the facility, from 500,000 to one million square feet.

"We are very pleased with the approvals of our two new manufacturing facilities intended to support Amgen's short- and long-term manufacturing capacity planning and meet the increased demand for our marketed therapeutics," said Dennis Fenton, executive vice president, Operations. "Our manufacturing success is grounded in exceptional science and an exceptional team of people who are deeply committed to advancing our ability to serve every patient, every time."

Since Amgen's founding in 1980, the company has been a pioneer in biologics manufacturing, developing some of the first — and most successful, according to the company — processes for large-scale protein production. Amgen has built one of the industry's largest manufacturing operations with major production facilities in California, Colorado, Rhode Island, Puerto Rico and Washington state, as well as a network of contract manufacturing partners around the world. Currently, the company produces more than one-third of the world's recombinant protein therapeutics, excluding vaccines and insulin, and is investing billions of dollars to further expand its manufacturing capabilities.