Pluri and Remedy Cell Expand Partnership, Reach Clinical-Grade Manufacturing Milestone
Pluri (NASDAQ: PLUR) and Remedy Cell have expanded their manufacturing collaboration, achieving an important milestone as clinical-grade production of Remedy Cell’s lead therapeutic candidate has now been successfully completed. The progress follows a series of successful engineering runs at Pluri’s GMP facility, confirming that Remedy Cell’s proprietary manufacturing process can be reliably transferred, scaled, and operated within a regulated environment.
The work was carried out through Pluri’s contract development and manufacturing arm, which integrated Remedy Cell’s process into its automated production systems. Training, qualification, and validation activities were completed alongside the engineering runs, ensuring consistency and compliance with clinical manufacturing standards.
Preparing for First-in-Human Studies
With these steps complete, multiple clinical-grade batches have now been produced and are intended for use in Remedy Cell’s upcoming Phase 1b clinical trial. Reaching this stage confirms that the therapy can be manufactured at the quality and scale required for human studies, reducing execution risk as the program advances into the clinic.
The achievement reflects close coordination between the two teams and demonstrates that Remedy Cell’s platform is compatible with Pluri’s manufacturing infrastructure.
A Broader, Deeper Collaboration
The expanded agreement builds on an existing partnership and positions Pluri to continue supporting Remedy Cell through future clinical development stages. Pluri’s manufacturing capabilities, which focus on complex cell-derived and cell-free biologic products, are now aligned with Remedy Cell’s near- and mid-term development timeline.
For Remedy Cell, the collaboration provides access to a fully qualified GMP production environment as it advances therapies targeting fibrotic diseases with high unmet medical need.
Context and Next Steps
Pluri’s CDMO platform leverages its proprietary cell expansion technologies and automated bioreactor systems to deliver scalable, regulatory-compliant manufacturing for advanced biologics. Remedy Cell’s lead program is focused on cell-derived, cell-free therapies, including candidates being developed for conditions such as idiopathic pulmonary fibrosis.
With clinical-grade material now in hand, the partnership moves from process validation into execution, supporting Remedy Cell’s transition from development into clinical evaluation.
