The GMP certification has brought renewed energy and confidence in the future to the 25-strong team at Diamyd Medical’s manufacturing unit in Umeå.
“This demonstrates that we can deliver at the highest standards. There are few facilities like this in Sweden. It is clear proof of our quality and technical expertise and strategically very significant for our site,” says Sofia Mayans.
Following the company’s Phase 3 study of its diabetes vaccine, which did not meet its endpoints, operations in Umeå have been reoriented. The focus is now on attracting external customers, alongside strategic efforts concerning the facility’s future.
“We are now focusing on leveraging the ‘Umeå spirit,’ creating synergies, identifying partnerships, and reaching out broadly to potential customers and partners. We have already established an international presence, including through Umeå Biotech Incubator at LSX Nordic in Copenhagen, and we are in dialogue with both Business Sweden and the Municipality of Umeå.”
At the same time, she sees potential in attracting a larger CDMO player looking to establish a site in the Arctic region. Sofia Mayans highlights that Umeå’s geographic location and Diamyd Medical’s expertise could contribute to manufacturing capacity both in Sweden and across the Arctic region.
“Umeå already hosts an army regiment, FOI (the Swedish Defence Research Agency), the Swedish Armed Forces’ CBRN Defence and Security Centre, two universities, and a university hospital for clinical trials. If we can also offer pharmaceutical manufacturing, we further strengthen the region’s overall capabilities,” says Mayans. “Together with APL, which can formulate drug products, we can also create the conditions for a more complete local production chain.”
“Building this type of operation takes time. That is why our approval is a strength for the entire region,” she concludes.