At a Glance
- Companies: Cellares, Cabaletta Bio
- Focus area: Autologous CAR-T manufacturing
- Product: rese-cel (resecabtagene autoleucel)
- Agreement length: 10 years
- Next steps: Scale commercial supply and launch readiness
What happened?
Cellares and Cabaletta Bio signed a 10-year commercial supply agreement to support manufacturing of Cabaletta’s CAR-T therapy rese-cel on Cellares’ automated Cell Shuttle platform. The deal extends a collaboration that has already produced clinical manufacturing milestones, including the first patient doses made on Cellares’ system.
Why does it matter?
Autologous cell therapy manufacturing is one of the biggest bottlenecks in CAR-T, because every dose has to be made from a patient’s own cells. A long-term agreement with an automated platform could help Cabaletta scale supply more reliably, improve scheduling flexibility and lower cost of goods as rese-cel moves toward commercialisation.
Who’s behind it?
Cellares describes itself as an integrated development and manufacturing organisation focused on end-to-end cell therapy production. Cabaletta Bio is developing rese-cel for autoimmune diseases, and has been working with Cellares since 2023 to adapt the process for automated, GMP-ready manufacturing.
How was it achieved?
The companies generated comparability data across engineering runs to show that Cellares’ Cell Shuttle could reproduce Cabaletta’s established process. That data supported FDA clearance of an IND amendment for clinical manufacturing, and Cabaletta has already dosed the first patients using drug product made on the platform.
What’s next?
The agreement is aimed at supporting launch readiness and future commercial demand if rese-cel is approved. Cabaletta expects clinical manufacturing data to help confirm GMP readiness and supply-chain logistics, while Cellares continues building out its automated manufacturing footprint.
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