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.

Source link

Stay Connected


Latest Articles

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...

Telangana caps Covid treatment charges in private hospitals

Hyderabad: The government of Telangana on Wednesday issued orders fixing treatment and investigation charges for Covid-19 in private hospitals.The state government, which had capped...