- NorthX Biologics has entered a long-term collaboration with Diamyd Medical and APL to prepare retogatein (rhGAD65) for commercial manufacturing.
- The collaboration brings together drug substance production, fill and finish, and validation to support scale-up and regulatory readiness in Sweden.
NorthX Biologics has entered a long-term collaboration with Diamyd Medical and APL to support the preparation of retogatein (rhGAD65) for commercial manufacturing. Retogatein is being developed as a therapy aimed at preserving insulin-producing cells in people with type 1 diabetes. The collaboration is intended to support later-stage development and future commercial supply.
The partnership combines Diamyd Medical’s in-house drug substance manufacturing, APL’s fill and finish capabilities, and NorthX Biologics’ validation and characterisation expertise. As Diamyd Medical moves closer to commercialisation, NorthX Biologics will be responsible for characterising and validating the drug substance process, including validation planning, documentation management, and ensuring regulatory requirements are met during scale-up.
“The collaboration builds on existing work between the partners. By combining Diamyd Medical’s in house drug substance manufacturing with APL’s long standing fill and finish expertise, and now adding the validation capabilities of NorthX Biologics, we are creating a sustainable structure for continued development while strengthening Sweden’s manufacturing capabilities within biologics.”
Ulf Hannelius, Chief Executive Officer of Diamyd Medical
Together, the three companies form an integrated manufacturing chain covering drug substance production, fill and finish, validation, and preparation for commercial supply. The structure is designed to reduce risk and provide a more predictable path towards scale-up, supporting contract manufacturing activities for advanced biologics.
NorthX Biologics said the collaboration is intended to ensure that the manufacturing process for retogatein is robust, compliant, and ready for the next stage of development, with the longer-term aim of supporting future access to the therapy for people living with type 1 diabetes.
