- Diorasis Therapeutics has partnered with Northway Biotech to develop a scalable cGMP manufacturing process for its lead AAV-based gene therapy candidate targeting open angle glaucoma.
- The agreement covers process development, analytical method development, and clinical-grade manufacturing to support planned clinical trials.
Diorasis Therapeutics has announced a strategic partnership with Northway Biotech, a contract development and manufacturing organisation (CDMO), to establish a scalable current Good Manufacturing Practice (cGMP) process for its lead gene therapy candidate in open-angle glaucoma.
The collaboration will support AAV process development, analytical method development and qualification, pre-clinical material production, and cGMP manufacturing of both drug substance and drug product for future clinical trials. Northway Biotech brings over two decades of experience in biologics contract manufacturing to the project.
The partnership marks a key step for Diorasis Therapeutics as it prepares to move its lead programme into clinical development. The company’s gene therapy is designed to offer a durable, single-dose treatment for open angle glaucoma, potentially transforming standard care for patients at risk of irreversible blindness.
Remis Bistras, CEO of Diorasis Therapeutics, called the agreement “a critical milestone as we advance our lead gene therapy candidate toward the clinic.”
Northway Biotech’s CEO and Chairman, Prof. Vladas Algirdas Bumelis, highlighted the importance of trust and communication in the collaboration, noting that their team is committed to delivering a reliable and scalable process for clinical transition.