Aug 24 2009
Karolinska Development (publ), managing one of the largest portfolios of life science research companies in Europe, announced that XSpray Microparticles AB has launched a GMP production facility in Malmo, Sweden. In addition to offering particle development and characterization services, XSpray can now provide customers with high quality drug particles and powders for use in their clinical studies.
Conny Bogentoft, CEO of Karolinska Development, said, "We are extremely pleased with the development of this technology. The ability to produce GMP material is an important step both for XSpray and for Karolinska Development. It will enable this remarkable solution for pharmaceutical particle production to benefit other companies within our portfolio as well as external customers. Currently we have twelve 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."
XSpray's RightSize(TM) Particle Manufacturing Technology is a ground-breaking solution for pharmaceutical particle development and production based on supercritical fluid technology. Overcoming many of the drawbacks of traditional micronization it is well suited to demanding applications, such as inhaled compounds, sparingly soluble compounds and biopharmaceuticals. As well as offering all the advantages of earlier supercritical fluid technologies it is also fully scalable.
The new GMP facility has been developed in collaboration with Galenica AB, an established Swedish CRO focused on pharmaceutical formulation. Manufacturing will be carried out by Galenica at the company's state-of-the-art GMP suites in Malmo, Sweden.