The facility, located in the southern city of Malmo, will manufacture drug particles and powders for pharmaceutical and biotechnology customers, expanding on XSpray’s existing range of particle development and characterization services.
Swedish contract research organisation (CRO) Galencia, which co-developed the facility, will run manufacturing operations using XSpray’s RightSize particle platform.
The technology uses supercritical fluid technology to induce the precipitation of uniform active pharmaceutical ingredients (API) from solution, in an excipient-free process designed to improve productivity and reduce costs.
RightSize skips the harvesting, drying and milling steps required by traditional micronisation, in an approach that XSpray claimed reduces waste and improves the quality of the final particle product.
The firm added that the technology is particularly suited to the manufacture of APIs, sparingly soluble compounds and drug particles for inhaled medications and biopharmaceuticals.
XSpray’s CEO, Per Andersson said that the Malmo plant will help satisfy demand for GMP material and “also proves the [RightSize] technology can be scaled up [which is] an important step towards full pharmaceutical manufacturing capability.”
Galencia’s CEO, Ronnie Wallin, also acknowledged that the particle precipitation technology works at the larger-scale.
“Testing the technology went very smoothly and we established a production capacity that meets clinical study requirements,” said Wallin, adding that compliance with European and US standards means that manufacture can begin straight away.
The new facility will also provide pharmaceutical and biotechnology customers with packaging and release testing services on a contractual basis.