XSpray Microparticles established GMP production capabilities in Malmö, Sweden. The company will thus now be able to provide GMP particle and powders for clinical trials besides particle development and characterization services. The GMP site was developed in collaboration with Swedish pharmaceutical formulation CRO Galencia.
XSpray is exploiting a supercritical fluid-based particle manufacturing platform called RightSize™. The company claims the technology solves many of the problems associated with traditional micronization methods and is ideally suited to applications ranging from inhaled compounds, sparingly soluble compounds, and biopharmaceuticals.
The RightSize platform employs supercritical fluid technology using an antisolvent to enable the controlled precipitation of APIs or drug substances in a single step without the addition of excipients, XSpray says. The process yields consistent powder particles in terms of size, shape, and morphology, which can be incorporated into tablets, capsules, as well as inhalation systems, the firm adds. Moreover, the RightSizeT technology can be effectively scaled-up to commercial volumes, opening up new possibilities for the reformulation of existing products as well as the formulation of NCEs, the company continues.
XSpray is a portfolio company of Karolinska Development. The ability to produce clinical-grade material is important both for XSpray’s offerings to the pharma industry and for Karolinska Development’s other portfolio companies, notes Conny Bogentoft, CEO 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.”