Bristol Myers Squibb Receives U.S. FDA Approval of New State-of-the-Art Cell Therapy Manufacturing Facili
Benzinga The company's third commercial CAR T manufacturing facility in the U.S. further extends Bristol Myers Squibb's leadership in cell therapy
Bristol Myers Squibb BMY today 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.
