The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts.
The new 244,000ft² facility represents Bristol Myers Squibb’s third commercial CAR T [chimeric antigen receptor T-cell] manufacturing facility in the country and the second significant expansion of its 89-acre Devens site.
The site has been involved in the development, manufacture and testing of clinical and commercial medicines.
It is a key part of the company’s increasing international cell therapy manufacturing footprint for the long-term supply of its cell therapy portfolio.
A patient’s own T cells are used in the manufacturing of autologous cell therapies.
This process is both operationally and technically complex. Each engineered T cell batch is manufactured separately and infused back into the cancer patient.
Bristol Myers Squibb senior vice-president and global cell therapy franchise lead Lynelle Hoch stated: “Bristol Myers Squibb’s vision of putting more patients on a path to potential cure starts with delivering on the promise of our current product portfolio and future pipeline.
“Today’s approval underscores our commitment to deliver our transformational CAR T cell therapies to more patients.”
The company operates two further research and development facilities in Cambridge, Massachusetts.
It intends to combine these two sites into a new building at Cambridge Crossing later in 2023.
Bristol Myers Squibb has three advanced cell therapy manufacturing facilities in Summit and Warren, New Jersey, and in Bothell, Washington.
A further site is under development in Leiden, the Netherlands.
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