Bristol Myers' cell therapy manufacturing site in Massachusetts is good to go, FDA says
With two cell therapies approved and three more in its pipeline, Bristol Myers Squibb is working to beef up its manufacturing capabilities for the complex, personalized, one-and-done medicines.
On Thursday, BMS took a positive step in that direction as the FDA gave the go-ahead for the company to begin commercial cell therapy manufacturing at its sprawling facility in Devens, Mass.
The cell therapy portion of the Devens site includes 244,000 square feet and has been under construction since 2021. It becomes BMS’ third commercial CAR-T manufacturing facility in the U.S. and adds more than 500 new cell therapy jobs.
BMS’ cell therapies, Abecma and Breyanzi—both for blood cancers—were approved a month apart in early 2021. Abecma pulled in sales of $388 million in 2022, up from $164 million the previous year. Breyanzi generated $182 million in revenue in 2022, following sales of $87 million in 2021. They rang up sales of $147 million and $71 million respectively in the first quarter of this year.
Expansion of the company’s global manufacturing footprint is critical to supplying these products. BMS and its rival—a partnership between Johnson & Johnson and Legend Biotech—have struggled to meet demand for their BCMA CAR-Ts. And these expansions become even more important as the companies look to add new indications and move into earlier lines of treatment.
BMS also has a manufacturing facility in Bothell, Wash., which supports production of Breyanzi and BMS’ other investigational cell therapies. BMS also produces cell therapies at smaller sites in Warren and Summit, New Jersey.
Another cell therapy manufacturing site, which will cover 205,000 square feet, is in development in Leiden, Netherlands. Seven weeks ago, BMS also revealed that it was taking over a former Novartis site in Libertyville, Illinois, where it will perform viral vector production for cell therapies.
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