Source: University of Glasgow.
University of GlasgowThe Wolfson Medical School is located at the University of Glasgow in Scotland, UK.
On May 21, 2013, representatives from a wide range of medical disciplines met at the University of Glasgow’s School of Medicine for a free conference organised by the MaterialsKTN, a publicly funded body responsible for distributing UK government funding to help develop technology and engineering in materials sciences. The funding is provided by the UK government’s Technology Strategy Board. Sam Anson reports from the event.
“Ceud mìle fàilte”, or “one hundred thousand welcomes”, began the opening address by Graeme Boyle, senior programme manager for Health Science Scotland, a collaborative organisation of leading Scottish universities, the Scottish arm of the UK’s Natinoal Health Service (NHS) and a number of government institutions. This friendly reminder that we were in a country whose people are currently pondering the reality of an independent Scotland was quickly followed up with a stark statement that the healthcare industry is facing a challenge in managing growing numbers of cases of chronic diseases like diabetes, respiratory diseases, cancers and cardiovascular complaints.
Opening the conference was Steve Morris, a biochemist by trade and a representative of the MaterialsKTN. Steve explained that the goal of the MaterialsKTN was to help drive innovation by facilitating collaborations between industry and academia. He remarked: “We’re helping SMEs who have less resource to develop technology and skills, we help to link these people up and make things happen”. At the time of going to press, the MaterialsKTN had around 9,000 individual and 5,000 organisational members.
The first speaker was Dr Laura Waters of Huddersfield University. Dr Waters presented research on achieving controlled drug release from novel porous excipients. Her presentation covered ways of modiying drug formulations for better control, like microwaves and supercritical carbon dioxide, focusing mainly on silica-based exipients. A member of the audience from GSK raised a question at the end about how the researchers expected to deal with silica in the body, pointing out that it might become silicon. Dr Waters stated that this was an important area that her team was aware of and that more research was required to explore it further. Dr Waters credited researchers in Cork, Ireland, for work on supercritical carbon dioxide modification of exipients.
Next up was Tim Ashton, vice president of innovation at vascular graft and stent-graft manufacturer Vascutek. Tim presented an interesting discussion of how innovators are faced with maintaining a balance between conservatism and innovation when using new materials. Tim pointed out that while new materials provide benefits in terms of performance, a proven track record of usage in existing devices prevents devices getting slowed down at the regulatory approval stage. Tim presented two case studies, one regarding how he went about choosing a new fluoropolymer coating for a textile vascular graft and another which involved a nitinol alloy for a stent-graft used to treat abdominal aortic aneurysm (AAA). Tim also outlined several tests which were undergone during evaluation of the latter product, including fatigue testing, a simulated implant test and vibratory tests. The simulated implant test put the device to 400 mn cycles.
Tim touched on a regulatory issue facing device makers at the moment, that getting approval for new devices was often quicker in Europe than in the USA. When asked to comment on the proposed Scrutiny Procedure in the new medical device regulations Tim said that he felt it was important that device makers in Europe got behind Eucomed’s Don’t Lose the 3 campaign to persuade European policy makers that the industry does not need a regulatory system that is heavy handed and slow. The reference to the number three in the Don’t Lose the 3 slogan refers to a three-year advantage European patients have when it comes to having access to innovative medical devices three years before the rest of the world.
Following Tim was Dr Catherine Berry of the University of Glasgow. Catherine presented on inorganic nanoparticles, explaining how nanoparticles can be introduced inside cells and targeted towards the nucleus using a magnetic field. Catherine also touched on work on stem cells.
The presentation before lunch was by Prof Andrew Lewis of Biocompatibles UK, a company owned by UK specialist healthcare products manufacturer BTG International. Andrew talked about a drug-device combination product manufactured by BTG called DC Bead. The device, for embolisation—the act of deliberately blocking blood flow to arteries, for instance to starve a tumour of its oxygen and nutrient supply—makes use of microspherical balls of PVA hydrogel previously used to make contact lenses.
At present, the product is sold in vials and it is up to the hospital pharmacist to add the drug to the microspheres just prior to its use in the patient. There was discussion among delegates at the end of the paper about the fact that the approval procedure for a product pre-loaded with drugs is much longer than that for the product in its current state—ie without any drug content.
After lunch, presentations were made by Fujifilm Diosynth—which recently developed a GMP-standard manufacturing line for animal-free gelatin, a recombitant peptide (RCP) material, in Billingham, UK—and Dr Mark Whittaker of biopharma company Critical Pharmaceuticals.
RCP is used for a variety of medical applications, the most popular being a good collagen-based scaffold material for endothelial cells. The manufaturing process involves, as a first step, a yeast fermentation process, followed by purification via chromotography and ultra filtration.
Mark Whittaker has worked with supercritical carbon dioxide and human growth hormone to improve patient experiences, particularly important with children, by making human growth hormone injections less painful.
I left the day before the last two papers were presented. But Phil Jackson the MaterialsKTN’s expert in ceramics and medical devices kindly shared his notes, including details of Mark Whittaker’s presentation, published as follows.
Dr Mark Whittaker of Critical Pharmaceuticals discussed how use of supercritical CO2 allowed intimate mixing of drug within plasticised polymer chains. PLGA and PLA were cited as examples of polymer employed. As well as avoiding the use of potentially toxic solvents, the lower temperatures (31.1°C with 73.8 bar) involved in generating supercritical CO2 are ideal when dealing with heat-sensitive drugs. When a pressure drop is applied, the supercritical state in the mixing chamber is lost and the polymer-drug mix emerges as a particle or fibre. Dr Whittaker outlined the application of growth hormone treatment, where drugs processed via the supercritical CO2route demonstrated sustained release, thus reducing the number of injections required by (younger) patients. In addition to injectable powders, Critical Pharmaceuticals have also developed a version of the growth hormone drug for delivery via the nasal mucosa—this uses a micelle structure as an absorption promoter.
David Healy from Giltech outlined how their water-soluble glasses within the Corglaes (R) offered an alternative approach to drug delivery. Unlike Bioglass, the glasses are based on Sodium-Calcium-Phosphorous oxide chemistry (i.e. no silica present). Anti-bacterial elements like silver could be added to these glasses, with the breakage of M-O-Ag upon dissolution leading to all the silver ions being available for anti-bacterial performance. This contrasted with nano-silver systems where only small levels of silver atom displacement from nano-particle surfaces took place.
Applications for Corglaes included water purification, biodegradable stents, dental tissue reconstruction and drug delivery. Regarding tissue repair, in-vitro studies with Liverpool University are investigating how ions dissolved from glass might influence the way stem cells differentiate into specific cells such as osteoblasts etc.
The final presentation of the day saw the self-confessed “inventor addict” Professor Tony Anson (Brunel University) outline some fascinating medical concepts. Based firmly in a belief that novel materials need to work with, not against, natural processes, Professor Anson began with a review of metals, alloys, polymers and ceramics employed in prosthetics down the ages. Interesting insights included the fact many medical polymers were made from toxic monomer units (which would cause great problems should depolymerisation be initiated in the human body) and that potentially toxic alloys were rendered harmless through the formation of oxide barrier layers. The presentation then introduced the concept of using parylene or diamond-like coatings- DLC (applied using CVD, PVD, laser or electron beam technology) to enhance products. Examples given included use of DLC to generate (a) low-friction coatings on urinary catheters and (b) corrosion-resistance surfaces on stent or T-Al-V alloy implants. An extremely interesting concept centred around the fact both cells and implant surfaces have an electrical surface charge in aqueous environments. Thus, by embedding batteries into metal implants, it may be possible to attract cells to surfaces. This could be useful, for example, in avoiding loosening of femoral head stems inserted into the femur over time.
Phil’s report goes on to say that the day attracted a good balance of academic and industrial delegates to hear how developments in a wide range of materials are generating pharmaceutical and medical device offerings that better address sector drivers. It says that a common theme in all talks was a strong awareness of the drivers behind materials development in healthcare. For example, the following were recurring themes:
- Controlled and sustained drug release to lower the level of injections / tablet taking (thus enhancing patient compliance);
- Targeted drug delivery to avoid unnecessary impact on parts of the body not needing a drug;
- Enhancing survival rates associated with surgery; and
- Extending length and quality of life in patients with terminal illnesses.
The day had a very friendly and welcoming feel to it, in keeping with Glasgow University’s friendly culture. I took away a couple of non-medical anectdotes which are worth reporting. Apparently it has been said that in Glasgow that when offered a cup of tea of coffee it is “less of a choice and more of a guess”. For our non-UK readers that implies that the coffee and tea on offer have so little taste that you cannot tell the difference between them. On a slightly more medical related note, it was said at the conference that Albert Einstein died of an AAA— an abdominal aortic aneurysm.
Medical Plastics News would like to thank Malcolm Harold, membership manager at MaterialsKTN for helping with our coverage of the event. Medical Plastics News is a firm supporter of the UK’s Knowledge Transfer Networks (KTNs). The event featured some of the best quality content and engaging speakers that the editor has had the pleasure of attending. Added to this, the event was completley free to attend.
We look forward to the next one.
The Materials KTN is free to join, register at www.materialsktn.net.