The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb Company's biologics manufacturing facility in Devens, Massachusetts for commercial production of Orencia (abatacept).
The Devens facility, a state-of-the-art bulk biologics manufacturing facility, employs roughly 300 scientists, engineers, bioprocess operators, quality specialists and other skilled workers.
“The approval of our Devens site is an important milestone for Bristol-Myers Squibb as part of our strategic focus on delivering innovative biologic medicines for patients with serious disease,” said Lou Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb. “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.”
Bristol-Myers Squibb currently manufactures its biologic medicines in a company-owned facility in Syracuse, NY and through third party suppliers, and finishes and packages them in Manati, Puerto Rico. The Syracuse site will remain a key component of the company's biologics strategy and will serve as a center of excellence in process development and early product launch for the company's biologic medicines.
“Bristol-Myers Squibb is committed to building a strong manufacturing capability to support our growing biologics portfolio, and Devens is a key component of this strategy,” said Peter Moesta, senior vice president, Biologics Manufacturing and Process Development.
In 2010, the company announced the Devens facility received Leadership in Energy and Environmental Design (LEED) Silver certification while the laboratory and office building at the same facility received LEED Gold certification in December 2009. LEED certification, established by US Green Building Council and verified by the Green Building Certification Institute, is the nation’s preeminent programme for the design, construction and operation of high performance green buildings.
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.