XSpray Microparticles AB has launched its new GMP production facility in Malmo, Sweden. In addition to particle development and characterization services, the company can now provide high quality drug particles and powders for clinical studies.
XSpray's RightSize Particle Manufacturing Technology is based on supercritical fluid technology and is designed for applications, such as inhaled compounds, sparingly soluble compounds and biopharmaceuticals, and is fully scalable.
The new GMP facility was developed in collaboration with Galenica AB, a Swedish CRO focused on pharmaceutical formulation. Galenica will perform manufacturing services at XSpray's GMP suites in Malmo.
XSpray's chief executive officer, Per Andersson, said, "We are extremely pleased to have this facility in place, we can now satisfy our customers' needs for GMP material. This also proves the technology can be scaled-up, an important step towards developing full pharmaceutical manufacturing capabilities." Dr. Andersson continued, "We are very pleased with this collaboration with Galenica.
Ronnie Wallin, Galenica's chief executive officer, added, "Testing the technology went very smoothly and we established a production capacity that meets clinical study requirements. Our facilities comply with both EU and U.S. regulatory standards and we are now able to start manufacturing for XSpray's customers."
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