Bristol Myers Squibb gets USFDA nod for commercial production at newest Devens cell therapy manufacturing facility
Princeton:: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s newest cell therapy manufacturing facility in Devens, Massachusetts. The Devens site is a critical component of BMS’ expanding global cell therapy manufacturing footprint for long-term supply of the company’s cell therapy portfolio.
“The Devens facility integrates the latest state-of-the-art technology in the industry with top talent in the Boston area that will take us into the next phase of our cell therapy journey,” said Karin Shanahan, executive vice president, Global Product Development & Supply, Bristol Myers Squibb. “We are working diligently to increase our product capacity through new sites like Devens and by implementing innovative manufacturing solutions that help patients in need.”
Manufacturing autologous cell therapies is both operationally and technically complex because they are uniquely created using an individual patient’s own T cells as the starting material. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient. It is important to develop reliable quality supply with rapid turnaround time. The expansion of the company’s global manufacturing footprint is critical to supplying these products to patients with unmet needs around the world.
“Bristol Myers Squibb’s vision of putting more patients on a path to potential cure starts with delivering on the promise of our current product portfolio and future pipeline,” said Lynelle Hoch, senior vice president, Global Cell Therapy Franchise Lead, Bristol Myers Squibb. “The approval underscores our commitment to deliver our transformational CAR T cell therapies to more patients.”
The new 244,000 square foot cell therapy manufacturing facility represents the second significant expansion of BMS’ 89-acre Devens site, which has been developing, producing, and testing clinical and commercial medicines for over a decade. The Devens facility creates over 500 new cell therapy jobs. BMS also operates two R&D facilities in Cambridge, Massachusetts and will bring these two sites together into a new building at Cambridge Crossing later in 2023.
Devens adds to the company’s global network of three state-of-the-art cell therapy manufacturing facilities in Bothell, Washington; Warren, New Jersey; and Summit, New Jersey, with another manufacturing site in development in Leiden, Netherlands. BMS recently announced the addition of a new manufacturing facility and its operations for in-house viral vector production in Libertyville, Illinois.
*The new U.S. facility is planned to transition to Bristol Myers Squibb over the course of 2023, subject to the fulfillment of applicable closing conditions.
