Pharma Focus America

Bristol Myers Squibb's New Cell Therapy Manufacturing Facility in Devens, Massachusetts Receives U.S. FDA Approval

Friday, June 09, 2023

Bristol Myers Squibb (NYSE: BMY) announced today that its new cell therapy manufacturing facility in Devens, Massachusetts has received approval from the U.S. Food and Drug Administration (FDA) for commercial production. The Devens site is a vital addition to BMS' expanding global cell therapy manufacturing capabilities, ensuring a steady supply of the company's cell therapy portfolio in the long term.

Bristol Myers Squibb's Executive Vice President of Global Product Development & Supply, Karin Shanahan, expressed excitement about the Devens facility, stating that it integrates the latest state-of-the-art technology in the industry with top talent in the Boston area. Shanahan emphasized the company's dedication to increasing product capacity and implementing innovative manufacturing solutions to help patients in need.

Manufacturing autologous cell therapies is a complex process both operationally and technically, as each batch is uniquely created using a patient's own T cells. The Devens facility aims to establish a reliable and efficient supply with rapid turnaround time to meet the needs of patients worldwide. The expansion of BMS' global manufacturing footprint is crucial for providing these therapies to patients with unmet needs.

Lynelle Hoch, Senior Vice President of Global Cell Therapy Franchise Lead at Bristol Myers Squibb, highlighted the company's commitment to delivering their transformative CAR T cell therapies to more patients. The FDA approval of the Devens facility underscores this dedication.

The new cell therapy manufacturing facility in Devens spans 244,000 square feet and represents a significant expansion of BMS' existing site. It will create over 500 new jobs and contribute to the company's growth in the dynamic life sciences community of the Boston area. Bristol Myers Squibb operates three other state-of-the-art cell therapy manufacturing facilities in Bothell, Washington; Warren, New Jersey; and Summit, New Jersey. They are also developing another manufacturing site in Leiden, Netherlands. Additionally, the company recently announced plans for a new manufacturing facility in Libertyville, Illinois, focused on in-house viral vector production, further enhancing their cell therapy capabilities.

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