Bristol Myers Squibb, with a new weapon licensed for its Breyanzi CAR-T lymphoma therapy, is making a major cell manufacturing effort.
The company is building a new 244,000-square-foot cell treatment site, located at the company’s 89-acre campus in Devens, Massachusetts. The new factory will be fitted out to quickly ramp up clinical and commercial products, complementing Bristol’s existing cellular manufacturing operations in Washington, New Jersey, the European Union and Japan.
The move comes just weeks after Breyanzi’s CAR-T med at Bristol Myers won FDA green light in adults with recurrent or recurrent large B-cell lymphoma – and as the company expects to US approval for another CAR-T therapy, ide-cel, in multiple myeloma.
Bristol Myers says it will sign up to “several hundred” staff over the next few years to bring staff to the new center.
As of right now, Bristol Myers ’Devens campus currently handles process development, clinical manufacturing and commercial manufacturing for biology, including the drug immuno-oncology, the company said in the news.
Cell therapy therapy is a difficult beast, Bristol Myers admits: Treatments must be made individually for each patient, using the individual’s own T-cells as the starting material. Each batch of engineered T-cells is then made for introduction into the original cancer patient, highlighting the need for a rapid manufacturing turnaround.
That complex manufacturing process was an obstacle for Breyanzi last year. Individual FDA studies saw cases at the BMS center in Bothell, Washington, and the Von Lonza vector center in Houston.
The Bothell production site is now established, and Bristol Myers aims to bring another site online in New Jersey to turn out commercial and clinical products, chief medical officer Samit Hirawat, MD, told Fierce Pharma recently.