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 retogatein in the investigational medicine, an antigen-specific immunotherapy currently in late-stage clinical development.
The long-term objective for the facility is to support potential commercial-scale production of retogatein (rhGAD65), the active pharmaceutical ingredient in the investigational therapy, while also serving as a strategic hub for the manufacturing of biological substances for additional therapeutic programs.
Facility
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 manufacturing technology for the active pharmaceutical ingredient retogatein (rhGAD65), in the investigational medicine for the treatment of type 1 diabetes currently in late-stage clinical development.
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.
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 retogatein (rhGAD65) at the quality and scale needed to meet regulatory requirements and future market demand. Additional biomanufacturing projects will be evaluated to make full use of the site, platform, analytical laboratory and competencies.