Nexxus Scotland

XstalBio

The company began life as a spin-out in 2004 from the Universities of Glasgow and Strathclyde. Founder and CEO, Dr Marie-Claire Parker was a graduate of Strathclyde and an academic at Glasgow and it was her development approximately ten years ago of a new type of particle that had never been seen before that formed the basis for this highly successful spin-out.   

Initially incubated in the Chemistry Department within the University of Glasgow, it soon became clear that XstalBio was showing sufficient promise to merit Dr Parker giving up her University post to concentrate on exploring the commercial possibilities of the particle technology and building the business.   XstalBio established itself within new premises at the Centre for Integrated Diagnostic Systems (CIDS) at the University of Glasgow, where it remains today.

XstalBio's novel Protein-coated Microcrystal system (PCMC) is an enabling technology that is anticipated to transform the treatment of many diseases by allowing protein medicines to be delivered to the body in a range of new formats.   For example, proteins in development that would be delivered by injection, could with the PCMC technology, be inhaled instead. Such was the acclaim for the technology that in 2006 Dr Parker was presented with the Gannochy Trust Innovation Award of the Royal Society of Edinburgh (RSE) - the nation's top innovation award.

The company continues to go from strength to strength and is working with a number of major pharmaceuticals companies, on a range of opportunities.   In recent months, the company has also rolled out an analysis service for solid vaccine/protein formulations which is attracting interest worldwide.

It was not one of those "Eureka!" moments, so often described with scientific breakthroughs, but rather ".... that's funny ..?" when Dr Marie-Claire Parker developed a new type of particle, never before seen, in the process of undertaking research in the area of biocatalysis.

Quick to recognise that the new particle had pharmaceutical applications, a proof of concept grant in 2000 allowed for successful development of particles suitable for inhalation. A chance encounter at a conference stimulated interest from Boerhinger Ingelheim Pharma KG, one of the world's leading biopharmaceutical companies and the result was a milestone licencing agreement in 2005 for XstalBio's revolutionary protein-coated microcrystal (PCMC) technology.   The agreement includes construction of a GMP manufacturing plant capable of producing large quantities of sterile PCMC suitable for clinical trials and manufacturing rights to the jointly developed manufacturing process.

The PCMC technology enables proteins such as insulin to be attached to micron-sized (1/100^th of a millimetre) crystals so they can be inhaled, thereby offering an alternative to injection of medicines eg for either treatment of diseases of the lung, such as cystic fibrosis, or as using the lungs as a "doorway" into the body.  Less painful and easier for the patient, this leads to improved patient compliance.   Additional advantages are a potential improvement in the consistency of the medicine taken.   
 
The fact that the crystals are stable at 40⁰C, and under conditions of high humidity, has huge implications for the cold chain supply of vaccines and biologics around the world.   In remote areas where some of the transportation is done by donkeys or canoe, stabilisation at prescribed temperatures can be virtually impossible.   The World Health Organisation estimates approximately $200M a year is spent in maintaining the cold chain and wastage remains high.    XstalBio's technology means that despite fluctuations in temperature and humidity, the formulation isn't adversely affected. 
 

Applications of the technology are diverse and its use in bioterrorism is being explored in collaboration with Avecia Biotechnology.   With a grant of $3.9M from the US Government, the collaboration is investigating further development of Thraxine TM, the Government's anthrax vaccine.  This, like vaccines against plague, has a short shelf life and is therefore expensive to stockpile.   The stabilisation which XstalBio can offer would result in a longer shelf life whilst reducing cost and waste.

The technology is versatile enough to also offer the capability of developing a platform for
different delivery options for pharmaceutical substances other than inhalation. Such applications could include eg a reduction in the viscocity of drugs such as the breast cancer drug herceptin so that instead of the patient being infused with the drug in hospital over a period of several hours it could be delivered by a health professional, eg at a doctor's surgery.

Dr Parker says she doesn't anticipate moving the business out of the West of Scotland in the foreseeable future, though a move to premises with increased wet lab space may be on the cards soon. "It's not just the fact that our staff are local graduates and are all based here," she said.   "It's that we are able to tap into a lot of funding mechanisms here too eg from Scottish Enterprise and the Scottish Executive, to assist our growth and development.   Our business is global and the West of Scotland is an attractive and easy part of the world for clients to visit.   It's a fact of life nowadays a lot of business is conducted by email and telephone so it's essential to meet face-to-face.   Eating out in Glasgow, a trip to Loch Lomond and local attractions always go down well, helping to oil the wheels in the early stages of negotiations and cement relationships further down the line.   I think we have the best of everything here."

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