Pluri expands manufacturing agreement with Remedy Cell for clinical supply

Pluri, a biotechnology company headquartered in Israel, said it has expanded a manufacturing agreement with Remedy Cell to support GMP production of a stem cell–derived, cell-free therapeutic candidate for fibrotic diseases.

According to the announcement, Remedy Cell’s proprietary manufacturing process has been fully implemented at Pluri’s GMP facility through the biotech’s contract development and manufacturing organization (CDMO) unit, PluriCDMO. The work reportedly included GMP training and qualification of Remedy Cell personnel, engineering runs to confirm scalability and robustness, and the manufacture of multiple clinical-grade batches of Remedy Cell’s lead candidate.

Pluri said the batches are intended for use in Remedy Cell’s planned Phase Ib clinical trial and represent a key milestone in the program’s clinical development. The company added that the project demonstrates PluriCDMO’s ability to support complex cell-derived and cell-free manufacturing processes in a scalable and regulatory-compliant manner.

The expanded agreement will include additional manufacturing and process development activities as Remedy Cell advances its clinical and pre-commercial programs.