"It's not rocket science—it's actually more complex." So wrote Fortune magazine in 2004 about the manufacturing process for ENBREL® (etanercept) at Amgen's Rhode Island facility. The observation applies equally to the company's manufacturing operations in California, Colorado, Washington and Puerto Rico. Only a handful of companies worldwide have the expertise to manufacture biologically based medicines. Amgen is a leader among that elite group, producing more than a third of the world's output of non-vaccine and non-insulin protein therapeutics.
From the beginning, the company's contributions to the invention of a whole new field have been driven by a strong desire to meet the needs of patients. "Making proteins has always been a core competency for Amgen," says Dave Bengston, vice president and general manager, Rhode Island Operations, who joined Amgen back in 1983. "When the company began, producing recombinant proteins for use in people was new technology, so it's not like there were many places to farm it out. So we had to learn as we went along, taking the intent of FDA regulations and applying them to the new technology." Amgen also made a decision early on to build a strong Process Development group—a decision that is still paying off today as the company continues to innovate newer and more efficient ways to produce state-of-the-art therapies.

