Stockholm-based XSpray Microparticles has launched a GMP production capability to produce drug particles and powders for use in clinical studies, which augments the company's particle development and characterization services.
The fluid technology company worked with Swedish CRO Galenica to develop a GMP facility in Malmo. Galencia will conduct the manufacturing operations.
XSpray says in an announcement that the facility allows it to satisfy customer needs for GMP-quality volumes of its micronized drug particles and powders, used in inhaled compounds, sparingly soluble compounds and biopharmaceuticals. The facility proves that the micronization technique, based on supercritical fluid technology, can be scaled-up, a step towards full pharma manufacturing.
The facility complies with both EU and U.S. regulatory standards.
- here's the release