XSpray launches GMP production facility
Stockholm, Sweden 2009-08-20
XSpray Microparticles Launches High Quality Particulate GMP Manufacturing to US and EU Regulatory Standards.
XSpray Microparticles AB, a life science technology company, today announced the launch of its new GMP production facility in Malmö, 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.
XSpray's RightSize Particle Manufacturing Technology, a ground-breaking solution for pharmaceutical particle development and production is 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. 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 Malmö, Sweden.
XSpray's CEO, 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.
Galenica's CEO, Ronnie Wallin, 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 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."
For more information, contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00
+46 (0)8 730 37 00
Email: per.andersson@xspray.com