Bristol Myers-Squibb (BMS) will open a 244,000 square-foot cell therapy facility in Devens, Massachusetts expanding its global manufacturing network.
The site will initially manufacture BMS’ first CAR T cell therapy, Breyanzi (lisocabtagene maraleucel; liso-cel). The US Food and Drug Administration (FDA) approved the therapy this month to treat patients with relapsed or refractory large B-cell lymphoma.
The new facility at the company’s 89-acre Devens campus will be completed in 2021 with commercial manufacturing set to begin by 2023. Previously, BMS announced it will manufacture Breyanzi at its site in Bothell, Washington and then aimed to expand manufacturing to Summit, New Jersey.
Image/iStock: Feverpitched
The manufacturing of autologous cell therapies like Breyanzi are produced individually for patients. The T cells are first taken from the patient and then engineered for infusion back to the original patient meaning it is essential for manufacturers to develop a reliable supply and quick turnaround time.
“Manufacturing CAR T cell therapies is complex, but we’ve designed a reliable manufacturing and global supply chain network,” a spokesperson from BMS told BioProcess Insider. “Our facilities use cutting-edge technologies and have highly trained manufacturing teams to ensure the successful manufacture of our cell therapies.”
Breyanzi boasts a 24-day target turnaround time, and according to the firm the Devens site will help it accommodate patients geographically and create a network of treatment centers while enabling the company to prepare for future cell therapy launches.
According to the firm, following commercial production approval “Breyanzi will be available through an expansive network of treatment centers that will be Risk Evaluation and Mitigation Strategy (REMS) certified to support the appropriate use of Breyanzi, which is available only through the Breyanzi REMS program.”
The Devens site is part of BMS’ expanding presence in Massachusetts where it already operates two R&D facilities in Cambridge. The firm intends to merge the two sites together into a new building at Cambridge Crossing in 2023.
“In addition to growing our cell therapy manufacturing capabilities and footprint, we’re also expanding our talent pool,” said a spokeswoman for BMS. “Over the next few years, we plan to hire several hundred employees to support Devens operations. The Boston area offers a competitive talent pool, in addition to our existing sites.”
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