- Pluri has expanded its manufacturing agreement with Remedy Cell following successful GMP implementation and production of clinical-grade batches for a Phase 1b trial.
- The collaboration includes technology transfer, GMP training, engineering runs, and ongoing contract manufacturing and process development support.
Pluri, Inc. has announced the expansion of its manufacturing agreement with Remedy Cell Ltd., building on a collaboration first signed in 2024. The agreement covers GMP manufacturing and process development activities delivered through Pluri’s CDMO division, PluriCDMO™, in support of Remedy Cell’s stem cell-derived, cell-free therapeutic programme.
Under the collaboration, the companies have completed the implementation of Remedy Cell’s proprietary manufacturing process at Pluri’s GMP facility. Activities included GMP training and qualification of Remedy Cell personnel, execution of engineering runs to confirm scalability and robustness, and manufacture of multiple clinical-grade batches of Remedy Cell’s lead candidate for use in its initial Phase 1b clinical trial.
Pluri said the work demonstrates PluriCDMO™’s ability to support complex cell-derived and cell-free manufacturing processes in a consistent and regulatory-compliant manner. For Remedy Cell, the milestone represents progress towards clinical development of its secretome-based therapies for fibrotic conditions.
Building on the completed activities, the two companies have agreed to broaden the scope of their collaboration. PluriCDMO™ will continue to provide manufacturing and process development support as Remedy Cell advances its clinical and pre-commercial programmes, reflecting a longer-term contract manufacturing relationship.
“We are proud to continue strengthening our agreement with Remedy Cell, working together to achieve every project milestone — from technology implementation and engineering runs to the successful manufacture of clinical-grade batches for their first human trial.”
Yaky Yanay, Chief Executive Officer and President of Pluri
