XSpray Microparticles, a Swedish life science technology company, has opened a GMP production facility in Malmoe, Sweden. The company says it can now provide customers with high quality drug particles and powders for clinical trials, in addition to particle development and characterisation services.
XSpray's RightSize particle manufacturing uses supercritical fluid technology as an anti-solvent for controlled precipitation of an ctive pharmaceutical ingredient. Overcoming many of the drawbacks of traditional micronisation, it is said to be suitable for demanding applications, such as inhaled compounds, sparingly soluble compounds and biopharmaceuticals. Offering all the advantages of earlier supercritical fluid technologies it is also fully scalable.
The GMP facility has been developed in collaboration with Galenica, a Swedish contract research organisation focused on pharmaceutical formulation.
Galenica's chief executive Ronnie Wallin said: "Testing the technology went very smoothly and we established a production capacity that meets clinical study requirements. Our facilities comply with both EU and US regulatory standards and we are now able to start manufacturing for XSpray's customers. In addition to manufacturing, we also provide packaging and release testing services."
XSpray is a portfolio company of Karolinska Development and the ability to produce GMP material is an important step both for XSpray and Karolinska Development, according to Conny Bogentoft, chief executive of Karolinska Development.
"Currently we have 12 companies with ongoing clinical trials, seven in Phase II and five in Phase I, and the need for high quality GMP material is increasing as our portfolio matures," he said.