COVINGTON BIOTECH PLANT GETS FDA BOOST

Agency OKs treatment for people with immune deficiency diseases.

A Covington biotech operation has received government approval needed to start producing the first of its flagship products, a replacement therapy for treatment of people with immune deficiency diseases.

The endorsement from the U.S. Food and Drug Administration of the Shire facility will mean the company’s operations — accounting for a 900-person workforce — will grow to 1,000 by year’s end, according to Matt Walker, Shire’s chief of technical operations.

Moreover, approval of the company’s second high-stakes product — aimed mainly at victims of trauma, burns and wounds — will mean growth to about 1,500 within a couple of years, he said. “And we are hoping for that approval later this year.”

The Ireland-based company, which has U.S. corporate headquarters in Massachusetts, has four manufacturing plants. The others are in Los Angeles, Austria and Italy, Walker said. “You wouldn’t necessarily think about having one in Covington, Georgia.”

The plant was built on open land in 2012 with incentives from the state and the promise of hiring skilled employees who had been trained at Georgia Tech, the University of Georgia and other area schools, he said.

The state’s bioscience industry has grown rapidly, along with the nation’s, according to a spokeswoman for the Department of Economic Development. Bioscience firms employ more than 32,000 people, while the state’s research universities conduct more than $1 billion a year in related research.

Shire, which merged two years ago with a former spinoff from Baxter, now has sales of roughly $15 billion a year. The company specializes in treatments against rare diseases, a global market of about $100 million a year.

“There is a huge unmet medical need in rare diseases,” Walker said.

The company gathers plasma from donors around the United States and, through a laboratory process, extracts proteins from the substance to produce different treatments. The product just approved by FDA is immune globulin infusion. The product now awaiting an OK is albumin therapy.

CONTRIBUTED PHOTOS Shire’s Covington plant was built on open land in 2012 with incentives from the state.

At the packaging room at Shire’s Covington facility, products are readied for shipment. Shire now has sales of roughly $15B a year.