“This is a natural next step in work that has been built up over time,” says Ulf Hannelius, CEO of Diamyd Medical. “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.”

Diamyd Medical is responsible for manufacturing retogatein (rhGAD65) drug substance at its biologics manufacturing facility in Umeå, Sweden, currently undergoing GMP certification. The collaboration with APL, also in Umeå, on GMP fill and finish activities of retogatein has been ongoing for several years and continues to evolve in line with the needs of the program.

“Our collaboration with Diamyd Medical has developed step by step. We view this as a long-term partnership focused on quality, flexibility, and progressively meeting the higher regulatory requirements of later development phases and commercial manufacturing,” says Erik Haeffler, CEO of APL.

NorthX Biologics is joining the collaboration to support preparatory work for the process validation of the drug substance, while the manufacturing operations in the Umeå site move towards commercial scale manufacturing.

“Our role is to contribute with manufacturing experience, validation, and regulatory readiness as the process matures,” says Janet Hoogstraate, CEO of NorthX Biologics. This is a partnership designed to evolve over time, through close dialogue between all parties, and to reinforce Sweden as a strong base for biopharmaceutical manufacturing”.

The collaboration enables controlled scale-up, reduces manufacturing risk, and supports regulatory readiness as the clinical programs advance.