FDA approves new cell therapy manufacturing plant
Posted: 12 June 2023 | Caroline Peachey (European Pharmaceutical Review) | No comments yet
Bristol Myers Squibb has received approval from the US FDA to begin commercial production at its newest cell therapy manufacturing site.
Credit: BMS
The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts.
The 244,000 square foot facility in Devens is BMS’ third commercial cell therapy facility in the US. It is located on the company’s existing Devens site, which has been developing, producing, and testing clinical and commercial medicines for over a decade.
The site is a “critical component” of BMS’ expanding global cell therapy manufacturing footprint, the company said.
“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,” stated Karin Shanahan, executive vice president, Global Product Development & Supply, Bristol Myers Squibb.
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Autologous cell therapy manufacturing is both operationally and technically complex because they are uniquely created using an individual patient’s own T cells as the starting material, a BMS statement explained. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient. It is important to develop reliable quality supply with rapid turnaround time.
“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,” said Lynelle Hoch, senior vice president, Global Cell Therapy Franchise Lead, Bristol Myers Squibb.
The Devens facility is expected to create 500 new cell therapy jobs.
BMS’ cell therapy capabilities
BMS currently operates three cell therapy manufacturing facilities in the US. They are located in Bothell (Washington), Warren (New Jersey) and Summit (New Jersey). The company also recently agreed to acquire a US-based manufacturing facility in Libertyville (Illinois) and operations from Novartis, boosting BMS’ capabilities for in-house production of viral vectors.
BMS also operates two R&D facilities in Cambridge (Massachusetts), which it plans to bring together into a new building at Cambridge Crossing later in 2023.
In Europe, BMS is developing another cell therapy manufacturing site in Leiden, Netherlands.
