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XSpray’s RightSize Particle technology produces nanoparticles with a consistent size below 200 nm. The proprietary technology provides complete control over particle production, enhancing drug formulation options and optimizing the performance of challenging drug substances, such as poorly soluble compounds.

XSpray’s CEO, Per Andersson, said, “We are very excited about receiving this grant from Vinnova. It will enable us to broaden the application of our nanoparticle technology more quickly. It is also pleasing that the technology’s capabilities have been recognized in this way. There is a lot of competition for these grants. The fact that Vinnova shares our belief in RightSize technology is very encouraging.” 

For more information, contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00
Email: per.andersson@xspray.com

About VINNOVA
VINNOVA is Sweden’s innovation agency. Its aim is to increase the competitiveness of Swedish researchers and companies. VINNOVA’s task is to promote sustainable growth in Sweden by funding needs-driven research and the development of effective innovation systems. To this end, the agency has 220 million euro to invest in new and ongoing projects each year. www.vinnova.se/en/

About XSpray
XSpray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Particle manufacturing – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules and inhalation systems. RightSize Particle technology addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize Particle technology is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art manufacturing facility in Malmö, Sweden.

The technology uses supercritical fluid (SCF) as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The new patent approval covers both design and method patents relating to XSpray’s unique nozzle head, where precipitation of the drug substance takes place.

The breakthrough design enables reproducible production of small particles of specific sizes, required for the development of inhalable drugs. It also enables nanoparticles to be produced with a consistent particle size below 200 nm. The technology is compatible with a wide range of excipients. These can, for example, be added to increase stability and/or wettability in amounts from >50% down to trace amounts.

The dimensions of the actual fluid mixing and spray forming regions are kept constant at all scales. This means the technology can be effectively scaled up to drug manufacturing volumes. Consistent high-quality particles are produced, with full control over particle size, size distribution and polymorph, irrespective of production scale.

XSpray’s CEO, Per Andersson, commented, “RightSize Particle production offers significant advantages over traditional micronization technology. It provides an easy-to-operate, single-step process that gives the user full control over particle properties. As well as being used for developing new chemical entities, it is also ideally suited to drug reformulation and life cycle management.”

“As a fully scalable SCF-based technology, RightSize Particle production represents a significant breakthrough in drug particle manufacturing. Today, we already offer GMP production of clinical trial materials to support our growing customer base. As such, the patent is an important step that further strengthens the company’s intellectual property rights in the US,” added Dr. Andersson.

For more information, contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00
Email: per.andersson@xspray.com

About XSpray
XSpray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Particle manufacturing – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules and inhalation systems. RightSize Particle technology addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize Particle technology is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art manufacturing facility in Malmö, Sweden. Find out more at: www.xspray.com

Stockholm, Sweden – August 20, 2009. XSpray Microparticles AB, the Swedish life science technology company, today announced the launch of its new GMP production facility in Malmö, Sweden. This means, in addition to offering particle development and characterization services, XSpray can now provide its customers with high quality drug particles and powders for use in their clinical studies.

XSpray’s RightSize™ Particle Manufacturing Technology is a ground-breaking solution for pharmaceutical particle development and production based on supercritical fluid technology. It overcomes many of the drawbacks of traditional micronization and 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 also enables full scalability.

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. Not only does it mean that we can now satisfy our customers’ needs for GMP material but it is also proof of the scale-up capability of the technology. As such, it is an important step towards developing full pharmaceutical manufacturing capabilities.” Dr. Andersson continued, “We are also very pleased with the collaboration with Galenica. We have every confidence that our customers will benefit from an extremely high quality, professional service.”

Galenica’s CEO, Ronnie Wallin, added, “Testing of the technology has gone very smoothly and we have established a production capacity that meets clinical study requirements. Our facilities comply with both EU and US regulatory standards and, in addition to manufacturing, we also provide packaging and release testing services. We are currently in the final stage of installation and are able to start manufacturing for XSpray’s customers as soon as required.”

For more information, please contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00 
Email: per.andersson@xspray.com 

About XSpray
XSpray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Particle Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules and inhalation systems. RightSize Particle Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize Particle Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art GMP manufacturing facility in Malmö, Sweden. Find out more at: www.xspray.com

About Galenica
Galenica is a pharmaceutical technology CRO located in Malmö, Sweden. The company  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 GMP production of clinical trial material for Phase I-III. The company has broad skills and experience in development projects and manufacturing of pharmaceutical preparations, comprising the most common types of dosage forms. Galenica can assist within all phases of a project, from the identification of an efficacious substance until a complete pharmaceutical is in commercial production. For more information see:  www.galenica.se

Stockholm, Sweden – April 20, 2009. Xspray Microparticles AB, the Swedish life science technology company, has developed a cutting-edge solution for pharmaceutical particle production based on supercritical fluid technology. The Company’s RightSize Particle Manufacturing Technology overcomes many of the drawbacks of traditional micronization and is well suited to demanding applications. As well as offering all the advantages of earlier supercritical fluid technologies it also provides scalability. This means pharmaceutical companies have the opportunity to produce better quality particles and powders, from discovery all the way through to drug manufacture.

The first commercial agreement with a customer began in Q4, 2008. Since then, two additional, major pharmaceutical companies have also undertaken evaluation projects. Each of the companies is using the technology for a different purpose; one is studying crystallization, another is looking at solid dispersion and the third is working with nanonization (the production of nano-sized particles).

”Interest from pharmaceutical companies has been steadily increasing over the last twelve months or so,” commented Per Andersson, Xspray’s CEO. ”Despite the current economical climate we have secured three commercial agreements, which shows that customers are convinced by the benefits of the technology. This is an important step for the Company and confirms that we have a strong offering, capable of adding real value throughout the pharmaceutical process from development to production.”

To support the ongoing evaluation projects, and to meet an expected increase in future demand, Xspray has recently doubled the size of its service lab. The strengthening of human resources began in mid 2008 with the appointment of Mikael Bisrat as Chief Scientific Officer. Dr. Bisrat has more than 15 years experience in the industry and has a thorough understanding of the needs within pharmaceutical development projects. The most recent recruit is Helene Dérand, PhD, who joined the company in March 2009 as Sales and Marketing Director. Ms Dérand has broad-based experience gained from more than ten years in the biotechnology and medical technology sectors. She has held various management positions in both global and start-up companies with responsibilities ranging from R&D and clinical operations to business development.

Per Andersson continued, “We have recently expanded our service offering to include solid state characterization and analysis capabilities. Plus, we will be opening our new GMP production facility within the next month or so. There are some exciting opportunities ahead for Xspray, so it is important that we have a capable, dynamic organization in place to take full advantage of them.”

For more information, please contact:
Per Andersson, CEO, Xspray Microparticles AB
Tel: +46 (0)8 730 37 00   Email: per.andersson@xspray.com  

About Xspray
Xspray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Particle Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules, and inhalation systems. RightSize Particle Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize Particle Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

Xspray Microparticles has its headquarters and development laboratories in Stockholm, Sweden.

Stockholm, Sweden – December 01, 2008. The Swedish life science technology company, Xspray Microparticles AB, now offers solid state characterization services to complement its cutting-edge solution for pharmaceutical particle production. The new service will allow the Company to reduce project development times by offering high quality characterization and analysis of solid state particle properties. 

Dr. Mikael Bisrat, who joined Xspray in mid 2008 as Chief Scientific Officer, is responsible for the new service area. Dr. Bisrat has more than 15 years experience in the pharmaceutical industry, including several positions overseeing solid state characterization. In addition to his analytical skills, Dr. Bisrat also has a thorough understanding of the underlying needs within pharmaceutical development projects.

“At Xspray we are offering a high quality analysis service that is capable of meeting specific project and customer requirements. Using the latest analytical procedures and techniques we are able to provide comprehensive characterization of pharmaceutical solids,” commented Dr. Bisrat.

Xspray’s CEO, Per Andersson, explains the value of the new service, “We are obviously delighted to have someone of Mikael’s background and experience behind this initiative. It means we now have some fantastic resources in this area, which should greatly benefit our customers. Not only will it improve the infrastructure within development work but it will speed up the whole process. Rather than waiting on external lab resources we can now generate our own data far more quickly.”

The new service is available for both Xspray manufactured powders and particles, and those produced by third parties.

About Xspray
Xspray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Particle Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules, and inhalation systems. RightSize Particle Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize Particle Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

Xspray Microparticles has its headquarters and development laboratories in Stockholm, Sweden.

Org number: 556649-3671

Telephone: +46 8 730 37 00

Email: info@xspray.com

Stockholm, Sweden – August 01, 2008. Xspray Microparticles AB, the Swedish life science technology company, has appointed Dr. Mikael Bisrat, PhD, as Chief Scientific Officer. The appointment comes at a time when several pharmaceutical companies begin evaluations of Xspray’s cutting-edge particle production technology.

Prior to joining Xspray Dr. Bisrat was Director of Pharmaceutics at Biovitrum. He has more than 15 years of industrial experience as a formulation scientist, a research scientist and in managerial positions. His roles have included Associate Director Pharmaceutical Development at AstraZeneca and Director Pharmaceutics at Pharmacia Upjohn.

Commenting on the appointment, Per Andersson, Xspray’s CEO, said, “We are obviously extremely pleased to have someone with Mikael’s extensive experience on board. It is a crucial time for the Company as we start working directly with customer projects. Mikeal’s capabilities are an important factor both in terms of ensuring successful customer development projects and for Xspray’s long term strategic growth.” 

Dr. Bisrat is a co-author of three patents in the area of supercritical crystallization and he is also one of the co-founders of Xspray Microparticles. As such, he has a thorough understanding of the technology. “I am very excited about joining Xspray in a managerial capacity. RightSize Particle Manufacture has fantastic potential. It is a robust technology, but most importantly it allows companies to produce high quality particles right through the pharmaceutical development process, from discovery to manufacture,” commented Dr. Bisrat.

About Xspray
Xspray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ Particle Manufacture – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.

The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules, and inhalation systems. RightSize Particle Manufacture addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.

A key advantage of RightSize Particle Manufacture is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.

Xspray Microparticles has its headquarters and development laboratories in Stockholm, Sweden.

Stockholm, Sweden- November 9, 2007 – Xspray™ Microparticles AB a private company leading the development of super critical fluid technology for the manufacture of pharmaceutical particles announces financing has been approved to take it’s RightSize™ Particle Manufacture technology to GMP.

The new financing is a milestone payment, based on successful scale up of the RightSize Particle manufacture technology. It will be used to set up a fully validated GMP facility and will allow the company to implement the next stage in its strategy; manufacture of pharmaceutical particles under GMP condition with RightSize Particle Manufacture technology. Positioning Xspray Microparticles at the forefront of pharmaceutical manufacturing using supercritical fluid technology. The company will be presenting this technology at a seminar during the annual AAPS meeting in San Diego on the 14^th November, where Prof. Peter York, an acknowledged expert on pharmaceutical particle engineering will also be speaking.

RightSize Particle Manufacture technology is clearly differentiated by its scalability which makes this an ideal technology for the drug development process, being able to work at the scales needed from discovery through to production. ‘’Supercritical fluid technology has been developing over the last 20 years and has clearly demonstrated many advantages for producing pharmaceutical powders’’ Stated Dr. Per Andersson CEO of Xspray Microparticles, “but in the past scaling to the extent needed for pharmaceutical production has been challenging. The ease with which RightSize particle manufacture can be scaled opens the doors for pharmaceutical companies to reap the rewards offered by supercritical fluid technology.

About Xspray Microparticles AB

Xspray Microparticles is a development company with in depth knowledge of both super critical fluid technology and the drug development process; developing cutting edge platform technologies and offering solutions for the production of customised pharmaceutical particulate material. The process yields consistent powder particles in terms of size, shape and morphology that can be incorporated into a number of dosage forms including tablets, capsules, and inhalation systems addressing areas of unmet therapeutic need by enabling the development of drugs with enhanced delivery options, faster onset of action and adding innovative properties that really benefit patients. The unique ability to scale up the SCF RightSize Particle Manufacture technology enables super critical fluid technology to be used for the production of pharmaceutical particulates, enabling particle engineering for the production of pharmaceutical particulates.
More information about the company can be found at www.xspray.com

Xspray Microparticles has its global headquarters and development laboratories in Stockholm, Sweden