A new 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.
The 24 000 square feet site, comprising of e.g. 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 as 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 e.g. 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.
Diamyd Medical has chosen Cytiva’s configurable single-use bioprocess manufacturing platform FlexFactory for the process that is based on a baculovirus-insect cell expression system.
Small-scale experimental production of GAD65 is established at the manufacturing facility and large-scale production is being set up with the aim of having the biomanufacturing facility operational during 2024. Additional biomanufacturing projects will be evaluated to make full use of the site, platform, analytical laboratory and competencies.