Diamyd Medical plans for GMP Certification in 2025
Process validation, stability studies and other activities for GMP production of the active pharmaceutical ingredient GAD65 are ongoing to finalize all aspects regarding manufacturing, which is required for submitting a Biologics Licensing Application (BLA) for the Company’s investigational medicine Diamyd[®]. Full-scale technical batches of GAD65 have been produced at the wholly owned biopharmaceutical manufacturing facility in Umeå. Active pharmaceutical ingredient (API) has thereafter been formulated into Diamyd[®] and dispensed into vials by an external Contract Development and