Wednesday, July 7, 2021

Bristol Myers, hot off Breyanzi nod, plots new cell therapy factory in Massachusetts


Bristol Myers Squibb, freshly armed with an approval for its CAR-T lymphoma therapy Breyanzi, is making a major cell therapy manufacturing play.

The company is building out a new 244,000-square-foot cell therapy site, housed at the company’s 89-acre campus in Devens, Massachusetts. The new factory will be kitted out to quickly ramp up clinical and commercial production, augmenting Bristol’s existing cell therapy manufacturing operations in Washington, New Jersey, the European Union and Japan.

The move comes just weeks after Bristol Myers’ CAR-T med Breyanzi won an FDA green light in adults with relapsed or refractory large B-cell lymphoma—and as the company is anticipating a U.S. approval for another CAR-T therapy, ide-cel, in multiple myeloma.

Bristol Myers says it will sign on “several hundred” employees over the next few years to staff the new plant.

As it stands, Bristol Myers’ Devens campus currently tackles process development, clinical manufacturing and commercial manufacturing for biologics, including an immuno-oncology drug, the company said in a release. 

Cell therapy manufacturing is a tricky beast, Bristol Myers admits: Treatments have to be individually manufactured for each patient, using a person’s own T-cells as the starting material. Each batch of engineered T-cells is then made for infusion into the original cancer patient, highlighting the need for quick manufacturing turnarounds. 

That complex manufacturing process proved a stumbling block for Breyanzi last year. Separate FDA inspections spotted issues at a BMS plant in Bothell, Washington, and a Lonza viral vector plant in Houston. 

The Bothell production site is now up and running, and Bristol Myers aims to bring another site online in New Jersey to turn out commercial and clinical supplies, chief medical officer Samit Hirawat, M.D., recently told Fierce Pharma.



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