May 1, 2008 (Vol. 28, No. 9)

Taking Advantage of Resources, Bioscience Sector Has Posted Double-Digit Growth Lately
Wales’ most famous life scientist, Professor Martin Evans of Cardiff University, was one of the speakers at the recent “BioWales” meeting. Sir Evans won last year’s Nobel Prize for Physiology or Medicine for work on stem cells. At the meeting, he talked about the opportunities and challenges involved in delivering stem-cell therapies.

“There are already some big opportunities in stem cells for biotechs—those selling culture equipment, tissue culture, and media are doing well at present. This market will be especially good for companies that can get their processes validated,” he added. Once issues of safety, efficacy, and methods of delivery are sorted out, then stem cells will move to the clinic, although this may take many years, and it is hard to know which treatment will get there first. “I am sure stem-cell therapies will come through, because the ideas behind them are so good,” he concluded.

Although Wales is a small country, financial support from the EU and strong support from the Welsh Assembly Government are building up a bioscience industry with double-digit growth and a turnover of £1.3 billion. There are now about 200 bioscience companies in Wales, located mainly around Cardiff and Wrexham, with interests ranging from traditional biotech and agriculture to medical devices and diagnostics.

Recent initiatives include the new Institute for Life Sciences in Swansea, which will be a magnet for high-tech companies, and the extension of the region’s clinical trials infrastructure in cancer as well as other therapeutic areas.

Industrial Biotech

Industrial biotechnology is growing in importance in the U.K., and the Centre for Biocatalysis, Biotransformations and Biocatalytic Manufacture at Manchester University (CoE Bio3) is a hotbed of activity.

“We are beginning to understand how to use enzymes in the manufacture of fine chemicals,” said Stan Roberts, Ph.D., founder of CoE Bio3. “We want to do transformations that we cannot emulate with other forms of chemistry—to go from cheap materials to high-value products. There has been an explosion of interest in our work now that we can create enzymes with genetic modification that will work on nonnatural materials.”

CoE Bio3 will soon turn its attention to biofuels. A flagship project is being carried out at British Sugar’s sugar beet factory in Wissington. “Sugar beet gives the U.K. a fantastic platform to harness agriculture for biorefining,” stated Gary Punter, development manager, technology. The company set up the U.K.’s first bioethanol factory last year and reached full capacity within two weeks. By the summer it had produced 55,000 tons of bioethanol and now has partnerships with BP and DuPont.

One of the leading industrial biotech companies in Wales is Biocatalysts, a specialty enzyme company for the food industry. “There is a renewed interest in the enzyme industry because of biofuels, green chemistry synthesis, and enhanced crop utilization,” said Stuart West, M.D., of Biocatalysts. “The company can help with bioethanol production because it owns a patent on ferulic acid diesterase, which can help break down cellulose, seen as the source of second-generation bioethanol.”

One resource that Wales has plenty of is grass, which is why Steve Kelly, Ph.D., professor of microbial genetics and molecular biology at Swansea University, is working with the Institute of Grassland and Environmental Research, the Welsh Energy Research Company, and Biofuels Wales on obtaining bioethanol from grass. They are taking a genomic approach by cloning genes that can ferment the fructans in grass fructose polymers.

Cell Research

A number of small companies with promising drug products and cell technologies for medical and veterinary applications were showcased at “BioWales.”

The supply of high-quality hepatocytes for toxicological studies has long been a challenge in preclinical drug development. Refrigeration impairs the metabolic function of the cells, while yields after cryopreservation are often low. Abcellute developed a platform technology that permits the preservation and storage of fresh primary liver cells or hepatocytes for up to five days at nonfreezing temperatures without loss of biological function or principle biomarkers. The cells are embedded in a biomatrix that allows storage at 10°C and easy reactivation when needed.

“Our cells show sustained liver enzyme function, just like fresh cells,” said Nathan Griffiths, Ph.D., Abcellute’s CSO. Abcellute’s customers already include several big pharmas and a number of biotechs and CROs. The company recently signed a distribution agreement with LGC Standards.

Cells of another kind are the focus of Ovasort, which has developed a technology for sexing animal sperm. The company owns a patent on a process for discovering proteins on the cell surface of mammalian sperm. To date the process has been used to enrich for X-chromosome bearing cells. According to Ian Cumming, CEO, this information is being used to develop a low-cost sperm separation kit for sorting X- and Y-chromosome bearing cells in livestock breeding.

LifeForce Immune System Bank provides for the frozen storage of white blood cells. As explained by Bradley Stringer, Ph.D., cofounder of the immune system bank, this resource could be an insurance policy for future health needs. At the bank, a patient’s cells are separated into red blood cells, white blood cells, and plasma and then processed to extract all of their immune cells.

“We have a unique set of U.K. and U.S. regulatory licenses for this work,” Dr. Stringer reported. The benefits of the bank include the ability to replete the aging immune system and immune cells after HIV and immunotherapy for cancer, reducing the risk of infection during chemotherapy or radiotherapy, and protection after exposure to radiation.

On the drug discovery side, ProTides, a spinout from work on antiviral and anticancer nucleosides by Professor Chris McGuigan at Cardiff University, was recently acquired by Morvus Technology.

“These are prodrugs needing a kinase to activate them, which is the slow step,” Dr. McGuigan explained. Researchers at ProTides have modified these drugs to create more active clinical entities. The company has ongoing collaborations with Bristol-Myers Squibb, GlaxoSmithKline, and Roche. “All the drug companies are going after this—it is a blockbuster idea because it can resurrect things from the dust carts of industry,” Dr. McGuigan continued.

Centers of Academic Excellence

It has been proven that centers of academic excellence can help launch and grow biotech companies. The Institute of Life Science (ILS) is the new research institute for the Medical School at the University of Swansea. ILS is a £52 million collaboration between the Welsh Assembly Government, IBM, and Swansea University.

A major asset of the ILS is an IBM Blue C supercomputer, the largest computer dedicated to life sciences in the U.K. (2.7 teraflops power now, increasing to 30 teraflops in 2009). Blue C supports the ILS in its interdisciplinary approach to translational medicine, which covers areas like nanohealth, health technology assessment, and health services research.

ILS has tech transfer, incubator, and business facilities and is part of the National Mass Spectrometry Service Centre. It will be at the heart of the largest NHS trust in Wales with University status and a focus on clinical delivery and commercial partnerships, according to Professor John White, chair of the School of Medicine Research Committee.

Clinical Trials

Wales has a signficant infrastructure for clinical trials in place, anchored by the Wales Cancer Trials Network (WCTN), set up in 1998 and funded by Cancer Research U.K. and the Welsh Assembly Government.

In 1997, only 2.5% of Wales cancer patients were in trials, but by 2005, WCTN had increased this figure to 10%. Currently, there are over 100 cancer clinical trials running in Wales, with pharma companies becoming increasingly involved.

Clinical trials initiated by WCTN have been so successful that the network has expanded to cover the rest of the U.K. The Welsh Assembly Government has given money to finance this effort.

Another important center for clinical trials in Wales is the Wound Healing Research Unit at Cardiff University, which was set up in 1991 as the world’s first center for investigating complex, nonhealing wounds.

The unit, now part of the Cardiff Institute for Tissue Engineering and Repair, has done a great deal to raise the profile of this previously neglected area and has the capability to conduct Phase I to Phase III trials. Smith & Nephew, Johnson & Johnson, 3M, Bristol-Myers Squibb, and Intercytex are among the companies that have carried out clinical work at the Wound Healing Research Unit.

A more recent development is the launch of the Welsh Wound Healing Network, which has already produced a clinical trial deal between the unit and ZooBiotic, which is developing a larval therapy for chronic wounds. “This is a concrete deliverable from a group that has only been in existence four months,” said Professor Keith Harding, the Wound Healing Research Unit’s director. “Wounds are an important area in terms of healthcare costs and human suffering, and one where we can make a big difference.”

Major Biotechs in Wales

Meanwhile, Wales is also home to several large biotech companies. GE Healthcare has a 30-acre site at Bridgend, the Maynard Centre, where it manufactures a wide range of life sciences products and services. Ortho Diagnostics is opening a facility at the new Pencoed Technical Park where it will carry out the manufacture of diagnostic kits for HBV, HCV, and heart attack.

ConvaTec, part of BMS, is active in ostomy, wound care, and wound therapeutics. It has a development center in Deeside and manufacturing operations near Cardiff.

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