As he talks about the future of cell therapy, the enthusiasm of Cellares CEO Fabian Gerlinghaus is unmistakable.
“There’s about 2,800 cell therapies in development worldwide,” Gerlinghaus said in an interview. “The FDA projects that they’ll be approving 10 to 20 new cell and gene therapies every single year starting in 2025. There’s all of these—there’s thousands of drugs coming down the pipe.”
It's an exciting time for a cell and gene therapy manufacturer—especially one that believes it has developed a game-changing production platform.
Ready to bet on Cellares' platform is cell therapy leader Bristol Myers Squibb. Monday, the companies unveiled a partnership in which BMS will use Cellares’ robotic Cell Shuttle platform for automated manufacturing of a CAR-T cell therapy.
Cellares will perform a proof-of-concept transfer process for the manufacture of a BMS pipeline cell therapy. BMS will evaluate the automated process with comparability data.
BMS has three cell therapies in its pipeline and two approved CAR-T treatments—Abecma for multiple myeloma and Breyanzi for large B cell lymphoma. The portfolio gives the company one of the more advanced cell and gene therapy programs in the world.
“They’re giving us a key cell therapy asset to automate and transfer, so that we can prove to them that the Cell Shuttle is in fact a viable, scalable and cost-efficient manufacturing solution for them moving forward,” Gerlinghaus said.
The announcement comes less than a week after Cellares revealed a $255 million series C financing round with BMS as one of the investors.
California-based Cellares said the investment would be dedicated to completing its factory in Bridgewater, New Jersey. The site there will be able to produce 40,000 cell therapy batches a year, which is a tenfold increase in productivity compared with “conventional CDMO facilities," according to Cellares.
As for BMS, the company has worked through cell therapy manufacturing issues since launching its promising medicines. After Abecma's approval in 2021, the company acknowledged that demand was outstripping supply.
Aside from capacity limitations, the company noted that there was an industrywide shortage of viral vectors used to deliver cell therapies.
On Breyanzi, the company last year blamed a sales shortfall on production limitations for the lymphoma drug.
BMS has been busy working to grow its own cell therapy manufacturing capacity, and, in 2021, the company said it would use automation and virtual reality at its production plants.