Ensuring quality and safety in orbital sterilization and manufacturing processes.
Manufacturing drugs in space requires a rigorous alignment between strict Earth-based GMP standards and the unique challenges of microgravity. Validating sterilization processes is a critical pillar for ensuring patient safety. Through the expertise of the Fedegari Technology Center, we are working to harmonize quality protocols, ensuring that every phase of production—from protein crystallization to advanced biological models—meets the highest global compliance standards. Our goal is to create a solid regulatory framework that allows therapies produced in orbit to be approved and utilized worldwide.