The biomanufacturing facility in Umeå is established to manufacture recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd. Diamyd is currently being evaluated in the confirmatory clinical Phase III trial DIAGNODE-3, for the preservation of endogenous insulin production and has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA.
Diamyd Medicals 2 200 square meters facility in Ersboda, Umeå comprises clean rooms, laboratories, warehousing, and office spaces. The staff are experts in cell cultivation, protein purification, and quality control, with a special focus on Good Manufacturing Practice (GMP).
Diamyd Medical is continuing to strengthen the company and, currently, new specialized expertise is joining the Diamyd Medical team in Umeå.
”We are recruiting process engineers for cultivation and for purification processes and a GMP Quality Assurance Specialist”, says Martin Linhult, CMC Lead, Diamyd Medical.
Martin Linhult earned his doctorate in molecular biology at KTH in Stockholm. He has extensive experience from several senior positions within the Swedish pharmaceutical industry, including previous experience in setting up facilities for clinical production, interacting with regulatory authorities at an international level, and bringing pharmaceuticals to the market.
He emphasizes the importance of perseverance and focus.
“As our investigational medicine is advancing through clinical phase III, we are committed and focused on completing the installation of our manufacturing equipment and facilities here in Umeå,” he asserts.
