A collaboration between Diamyd Medical, APL and NorthX Biologics adds further momentum to Umeå as a life science city. Diamyd Medical has expanded its manufacturing strategy through a long‑term collaboration with APL in Umeå and a strategic partnership with NorthX Biologics, a contract development and manufacturing organisation (CDMO) based in Matfors, Sweden. Together, the parties will further develop and scale up production of the biological drug candidate retogatein (rhGAD65) in preparation for potential future commercialisation.
The collaboration establishes an integrated manufacturing value chain encompassing in‑house active pharmaceutical ingredient (API) production, GMP‑compliant fill and finish, and preparatory activities for process validation. Together, this strengthens northern Sweden’s growing role in advanced biopharmaceutical manufacturing and adds further momentum to Umeå Life Science City, a collaborative life science environment built around close interaction between industry, academia and healthcare.
Demonstrates the depth of expertise available
“This collaboration demonstrates the depth of expertise available in the region,” says Sofia Mayans, Head of Manufacturing Site at Diamyd Medical in Umeå. “By working closely with established partners, we are building long‑term infrastructure and increasing the attractiveness of northern Sweden for life science development and manufacturing.”
Diamyd Medical established its biological manufacturing facility in Umeå in 2020, where the company produces the API retogatein (rhGAD65) for its investigational medicinal product targeting type 1 diabetes. The programme is currently in a late stage of clinical development, and the facility has been progressively expanded to meet increasing technical, quality and regulatory requirements.
Natural step to create a sustainable structure
Diamyd has previously collaborated with APL (Apotek Produktion & Laboratorier AB)on GMP fill‑and‑finish operations. With NorthX Biologics now joining the collaboration, additional expertise is added in preparation for process validation of the drug substance – an important step as the project advances towards later‑stage development and potential commercial manufacturing.
“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.”
Strong talent base at Umeå university
The manufacturing collaboration is underpinned by the region's availability of specialised talent.
“We are in an expansion phase and expect to continue growing,” says Mayans. “When recruiting, we require highly specialised expertise, and Umeå is an excellent place to be. Umeå University is a strong talent base, where students and researchers operate within an open and collaborative culture. This allows us to find both the right competence and the right people locally.”
Diamyd Medical currently employs 24 people in Umeå, where its manufacturing facility spans approximately 2,200 square metres. The company expects further growth as development progresses and manufacturing activities expand.
Aim to operate as a contract manufacturer
In the long term, Diamyd Medical aims not only to support commercial production of retogatein but also to leverage its facility and expertise to operate as a contract manufacturer for other biological drug development programmes.
Both APL and NorthX Biologics view the collaboration as strategically important.
”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.
”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,” says Janet Hoogstrate, CEO of NorthX Biologics.
Umeå Biotech Incubator (UBI) is one of Sweden’s state-of-the-art business incubators within the life sciences. We help researchers to use their data to the benefit of patients and citizens, improving their health. We support and train entrepreneurs in the fields of pharmaceuticals, diagnostics and medical engineering, and act as a bridge between academia, medicine and the business community.
