A facility for manufacturing of biological products is being set up in Umeå, the Capital of Västerbotten County in Sweden. The primary purpose is the manufacture of recombinant GAD65, the active pharmaceutical ingredient in the investigational medicine Diamyd®, an antigen-specific immuno therapy currently in late-stage clinical development.
The long-term goal for the facility is to produce enough GAD65 to meet the market demand for Diamyd®, as well as to be a key player in the production of biological substances for other drug projects.
Facility
The 24 000 square feet site, comprising of clean rooms, laboratory, warehousing and office space, will facilitate full control, predictability and scalability of the active pharmaceutical ingredient manufacturing technology. The property including the site as well 97 000 square feet of land area, is owned by Diamyd Medical’s subsidiary Diamyd Biomanufacturing AB.
The staff at the facility are experts in cell culture and protein purification, paving the way for the development for future precision medicine treatments of type 1 diabetes. We are in an active phase of expanding our workforce in Umeå with key competencies.
Small-scale experimental production of GAD65 has been established, large-scale technical production is ongoing and subsequent activities will ensure the reliable and replicable manufacturing of rhGAD65 at the quality and scale needed to meet regulatory requirements and future market demand for Diamyd®. Additional biomanufacturing projects will be evaluated to make full use of the site, platform, analytical laboratory and competencies.