XSpray Launches GMP Production Facility
XSpray's RightSize Particle Manufacturing Technology, a ground-breakingsolution for pharmaceutical particle development and production is based onsupercritical fluid technology. Overcoming many of the drawbacks oftraditional micronization it is well suited to demanding applications, suchas inhaled compounds, sparingly soluble compounds and biopharmaceuticals.Offering all the advantages of earlier supercritical fluid technologies it isalso fully scalable.
The new GMP facility has been developed in collaboration with GalenicaAB, an established Swedish CRO focused on pharmaceutical formulation.Manufacturing will be carried out by Galenica at the company'sstate-of-the-art GMP suites in Malmo, Sweden.
XSpray's CEO, Per Andersson, said, "We are extremely pleased to have thisfacility in place, we can now satisfy our customers' needs for GMP material.This also proves the technology can be scaled-up, an important step towardsdeveloping full pharmaceutical manufacturing capabilities." Dr. Anderssoncontinued, "We are very pleased with this collaboration with Galenica.
Galenica's CEO, Ronnie Wallin, added, "Testing the technology went verysmoothly and we established a production capacity that meets clinical studyrequirements. Our facilities comply with both EU and US regulatory standardsand we are now able to start manufacturing for XSpray's customers. Inaddition to manufacturing, we also provide packaging and release testingservices."
XSpray Microparticles AB is a life science technology company within-depth knowledge of supercritical fluid technology, solid state properties,formulation science and the drug development process. The Company'scutting-edge platform technology - RightSize(TM) Particle Manufacture - usessupercritical fluid as an antisolvent for controlled precipitation of anactive pharmaceutical ingredient/drug substance. The technology not onlyprovides a superior process to traditional methods but also delivers betterquality pharmaceutical particles, from discovery to production.
The process yields consistent powder particles in terms of size, shapeand morphology that simplify formulation and can be incorporated into avariety of dosage forms, such as tablets, capsules and inhalation systems.RightSize Particle Manufacture addresses unmet therapeutic needs by enablingthe development of drugs with enhanced delivery options, such as faster onsetof action, and by adding innovative properties that truly benefit patients.
A key advantage of RightSize Particle Manufacture is that it can beeffectively scaled up to production volumes, making it an importantbreakthrough in the manufacture of pharmaceutical particles.
XSpray Microparticles has its headquarters and development laboratoriesin Stockholm, Sweden, and offers GMP production at a state-of-the-art GMPmanufacturing facility in Malmo, Sweden. Find out more at:http://www.xspray.com
Galenica is a pharmaceutical technology CRO located in Malmo, Sweden. Thecompany offers preformulation and formulation, analysis, stability studies,documentation (CMC), GMP production together with project management.Galenica is authorized and audited by the Swedish Medical Agency for GMPproduction of clinical trial material for Phase I-III. The company has broadskills and experience in development projects and manufacturing ofpharmaceutical preparations, comprising the most common types of dosageforms. Galenica can assist within all phases of a project, from theidentification of an efficacious substance until a complete pharmaceutical isin commercial production. For more information see: http://www.galenica.seFor more information, contact: Per Andersson, CEO, XSpray Microparticles AB Tel: +46(0)8-730-37-00, +46(0)8-730-37-00 Email: firstname.lastname@example.org
SOURCE Xspray Microparticles AB
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