Crystal clear savings for drug giants
Drug companies could save millions thanks to a new technology to monitor crystals as they form.
The technique, developed by University of Leeds engineers, is a potentially invaluable tool in drug manufacture, where controlling crystal forms is crucial both to cost and product safety.
Most drug compounds are crystalline and their structure can affect both their physical attributes and their performance. Changes to these structures are often caused by undetected fluctuations in the process.
"If you were to use a pencil to write on glass you wouldn't get very far, but use a diamond and you could write your name. Yet both are pure forms of carbon. It's the same with different solid forms of the same drug; they can have completely different properties," says Dr Robert Hammond of the University's Faculty of Engineering, who leads the research team.
"Drug molecules are becoming increasingly complex and the challenges involved in processing them means that it is not always possible to successfully produce the desired form reliably. That's why there's such enormous potential for our system. We're now able to look at crystals as they are forming in a reactor, something that has never been done before."
The new technology identifies and monitors changes in crystal structures on-line, providing a method of ensuring production of the desired drug compounds. The bespoke system has been developed by engineers at the University of Leeds in collaboration with Bede X-Ray Metrology as part of the EPSRC funded Chemicals Behaving Badly programme.
Called polymorphism, changes in crystal structure during processing can lead to huge delays in bringing drugs to market, costing drug companies many millions of pounds. It can also lead to challenges to intellectual property protection. There have been a number of high profile cases where patents have been challenged by companies making an established formulation using a different polymorph.
"It's an enormous problem for drug companies," explains Dr Hammond. "Their patents are extremely valuable - they are granted for 20 years, but it can take ten years to bring a new drug to market, which only leaves another ten to recoup the cost of its development."
The technology developed at Leeds is based on the ‘gold standard' method for monitoring crystal structures - powder X-ray diffraction, the primary tool for studying polymorphs.
"There's enormous commercial potential for this technology, for example it could be developed to work at manufacturing plant scales and can be applied to speciality chemical industries as well," says Dr Hammond. "We're interested in talking to pharmaceutical and speciality chemical companies that can help us drive this forward."
Further information from:
Clare Elsley, Campuspr: tel 0113 258 9880, mob: 07767 685168, email [email protected]
Simon Jenkins, University of Leeds Press Office: tel 0113 343 5764, email [email protected]
Notes to editors:
1. This research is published online at Articles ASAP in a paper entitled An Examination of the Kinetics of the Solution-Mediated Polymorphic Phase Transformation between α- and β- forms of L-Glutamic Acid as Determined using On-line Powder X-ray Diffraction.http://pubs.acs.org/cgi-bin/abstract.cgi/cgdefu/asap/abs/cg0706215.html
2. Led by Professor Kevin J Roberts at the University of Leeds, Chemicals Behaving Badly is an EPSRC and industrial consortium which includes the universities of Leeds, Heriot-Watt and Newcastle, along with ten key industrial partners. It is primarily concerned with optimal design of batch reactors using in-process measurement and advanced modelling techniques. It works in measurement and modelling across the length scales relevant to pharmaceutical and inorganic fine chemical production.
3. The Faculty of Engineering at the University of Leeds comprises five Schools: Civil Engineering; Computing; Electronic and Electrical Engineering; Mechanical Engineering and Process, Materials and Environmental Engineering.
All schools in the Faculty have the highest 5 or 5* Research Assessment Exercise ratings, top teaching assessments and strong industrial connections. There are approximately 3,000 students in the Faculty, 80% undergraduates and 20% postgraduates. Two-thirds of our students are from the UK with the remainder representing over 90 different nationalities.
4. The University of Leeds is one of the largest higher education institutions in the UK with more than 30,000 students from 130 countries. With a total annual income of £422m, Leeds is one of the top ten research universities in the UK, and a member of the Russell Group of research-intensive universities. It was recently placed 80th in the Times Higher Educational Supplement's world universities league table and the University's vision is to secure a place among the world's top 50 by 2015.
5. The Engineering and Physical Sciences Research Council (EPSRC) is the UK's main agency for funding research in engineering and the physical sciences. The EPSRC invests around £800 million a year in research and postgraduate training, to help the nation handle the next generation of technological change. The areas covered range from information technology to structural engineering, and mathematics to materials science. This research forms the basis for future economic development in the UK and improvements for everyone's health, lifestyle and culture. EPSRC also actively promotes public awareness of science and engineering. EPSRC works alongside other Research Councils with responsibility for other areas of research. The Research Councils work collectively on issues of common concern via Research Councils UK. www.epsrc.ac.uk/