The US FDA has approved a 244,000 square-foot manufacturing plant in Devens, bringing a third CAR-T facility online for Bristol Myers Squibb (BMS).
In February 2021, BMS announced it was adding a facility at its 89-acre Devens campus to support the production of the then recently approved chimeric antigen receptor (CAR) T-cell therapy Breyanzi (liso-cel).
Last week, the facility was added to plants in Bothell, Washington and Summit, New Jersey to commercially produce the therapy, winning approval from the US Food and Drug Administration (FDA). The firm also has non-approved commercial cell therapy manufacturing plants in Warren, New Jersey, and Leiden, The Netherlands.
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“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, EVP of 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.”
Beyond Breyanzi, BMS has achieved commercial success with Abecma (ide-cel) for the treatment of multiple myeloma and has several more cell therapies in its pipeline (though in January the firm exited from a Phase I hematology CAR-T candidate acquired from Juno Therapeutics).
“Beyond Abecma and Breyanzi, this market is ripe for significant growth,” Chief commercialization officer Adam Lenkowsky told stakeholders at the Jefferies Healthcare Conference last week.
“There are projections out there that says the cell therapy market can grow to close to $30 billion by the end of the decade. It’s not going to get there only through hematologic malignancies, but we have other products in our pipeline right now.”
He added BMS’s presence in this potential market could be lucrative, as despite the “hundreds of biotech companies trying to get into cell therapy” the sector is not an area many companies will compete in.
“It’s too complex. The manufacturing is too difficult. The support is too difficult. And I think there would just be a few companies that are going to emerge as the leaders. And I think we’re poised to be one of the leaders in CAR-T in the near term and into the future.”