Setbacks to efforts to use Cellares’ automated platform to make an approved CAR-T cell therapy led BMS to terminate its partnership with the manufacturing specialist.
Bristol Myers Squibb has ended an alliance with Cellares after finding its former partner’s cell therapy system failed to meet the requirements necessary to make the CAR T-cell immunotherapy Breyanzi. Cellares plans to lay off about 100 people in response to the loss of the key contract.
In 2024, BMS struck a $380 million global capacity reservation and supply agreement with Cellares. The deal positioned BMS to use Cellares’ Cell Shuttle system for end-to-end, fully automated production of CAR-T cell therapies at clinical and commercial scales. Now, BMS has walked away from the deal after assessing the potential to use Cell Shuttle to make its CAR-T cell therapy Breyanzi.
“Following a comprehensive evaluation, Bristol Myers Squibb determined that the Cellares-partnered Cell Shuttle system could not meet the necessary requirements to make commercial Breyanzi,” a BMS spokesperson told BioSpace via email. “This determination is specific to Breyanzi and its established, regulatory-approved manufacturing process.”
The FDA approved Breyanzi, a CD19-directed CAR-T cell therapy, in 2021. BMS produces the drug through several internal sites, plus through specialized external manufacturers such as Oxford BioMedica.
Experts have cautioned in the past that changing cell therapy production post-approval is challenging. Anna McMahon, director of regulatory affairs at Cellares, told BioSpace last year that switching is “a significant investment.” McMahon advised companies to “ensure that the new platform is sustainable and a long-term solution.”
Cellares did not immediately respond to BioSpace about the implications of BMS’ findings for the prospects of using Cell Shuttle with other approved cell therapies. The company has previously cited the Advanced Manufacturing Technology designation the FDA awarded Cell Shuttle as a tool that could support manufacturing changes during development and after approval.
Layoffs were the direct consequence of BMS’ decision. Cellares CEO Fabian Gerlinghaus revealed on LinkedIn that the company is laying off staff in response to the loss of a partnership with a large pharma company, though he did not share the name of the pharma company or details of how many people are impacted.
Cellares’ WARN Act filing contains more details on the layoffs. The filing, which California’s Employment Development Department sent BioSpace via email, states that Cellares will permanently eliminate about 100 positions on Oct. 20. The planned layoffs will come 10 months after Cellares raised $257 million to plot a course toward commercial-scale production in 2027.
A wide range of roles are affected by the layoffs, with Cellares planning to part ways with staff including an alliance manager, a janitorial specialist and its vice president of commercial operations, according to the WARN documents. More than half of the affected employees have “senior” in their title. The affected senior employees work across areas including engineering, marketing, recruitment and software.
