Five years in the making and a year in testing, Bristol-Myers Squibb ($BMY) has now been given the go-ahead by the FDA to begin manufacturing at a new plant in Devens, MA.
The company is beginning with production of its injectable rheumatoid arthritis treatment Orencia, one of its best-selling drugs, but intends to expand the complex to accommodate a second biologic, reports Mass High Tech. The company in August received approval for a subcutaneous form of the pricey arthritis drug, which has been available since 2005 in IV form.
The 400,000-square-foot, 6-building complex has 300 employees and is looking to hire another 50, Bristol-Myers spokesman Ken Dominski told Mass High Tech.
Ground was broken on the project in 2007 and construction completed two years later, Dominski said. For a year, the company has been running equipment and testing the biologic processes for making Orencia. In March of last year, it began manufacturing a drug substance to demonstrate the processes to the FDA, the publication says.
The entire complex has LEED silver certification, indicating that it meets certain standards for energy efficiency, while the lab and office building have met LEED gold certification levels, according to a company release.
Bristol-Myers has a plant in Syracuse, NY, where it manufactures its biologics, and also uses contract manufacturers. It finishes and packages them in Puerto Rico at a facility that a couple of years ago received a warning letter from the FDA. Syracuse will continue to be used for development and early product launches for Bristol-Myers biologics, the release says.
"The increased manufacturing capacity from the Devens site will support market demand for Orencia and positions us well for future production of additional biologic medicines," says Lou Schmukler, president of global manufacturing and supply for Bristol-Myers Squibb.
- read the Mass High Tech story
- the press release