Pluri announced expansion of its manufacturing agreement with Remedy Cell. Under the ongoing collaboration, the companies have integrated Remedy Cell’s proprietary manufacturing process into Pluri’s GMP facility, completed GMP training and qualification for Remedy Cell’s manufacturing team, conducted engineering runs to validate process robustness and scalability, and produced multiple clinical-grade batches of Remedy Cell’s lead candidate. These batches are intended for use in Remedy Cell’s initial Phase Ib clinical trial.

The completion of these activities demonstrates PluriCDMO’s potential to serve complex cell-derived and cell-free processes with consistent, scalable and regulatory-compliant manufacturing solutions. For Remedy Cell, this represents a key step towards advancing its clinical development programme for secretome-based therapies targeting fibrotic diseases.

“Working with Pluri has been highly productive. Pluri’s expertise and professionalism have been invaluable in helping us reach this critical milestone. Completing our clinical-grade manufacturing and preparing for our first clinical trial is a defining achievement for Remedy Cell, and we look forward to continuing this productive partnership,” said Ayelet Dilion-Mashiah, Chief Executive Officer, Remedy Cell.

PluriCDMO will continue to provide additional manufacturing and process-development support as Remedy Cell advances its clinical and pre-commercial programmes. The expanded activity underscores the partnership between the teams and their shared commitment to advance next-generation, cell-free biologics that address significant unmet medical needs.

“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. Remedy Cell’s scientific approach is highly innovative, and it has been a privilege to contribute to their progress. This success further positions PluriCDMO as a trusted partner for companies developing complex, cell-derived therapies,” said Yaky Yanay, Chief Executive Officer and President, Pluri.