Much of this work is organised under the umbrella of the commercial programme at VLA with the aim of providing an efficient, profitable and high quality service to the commercial sector.

The Scientific Services unit (SSU) delivers the Agency’s core commercial services by supplying quality control testing of vaccines, residue and pharmacokinetic studies on antimicrobials and efficacy testing of anti-parasitic compounds. The unit is GLP, GMP and ISO17025 accredited and therefore able to generate scientific data to the standards required by both commercial customers and the regulatory authorities. During the year, SSU carried out 44 studies to a value of £1.3m in support of companies’ marketing authorisations.

Further activities include:

• Vaccine development projects
• Risk assessments
• Antibiotic sensitivity testing
• Diagnostic testing
• Sale and licensing of reagents
• Consultancies
• Quality assessment schemes
• Library subscription service

VLA offers a wide range of commercial services and contracts to a value of £4m were carried out across the Agency.

VLA also recognises that Intellectual Property Rights are key business assets. During the year a further four patent applications were filed to cover innovative developments in our TSE, TB and rabies research programmes. However, proprietary know-how and patents are only assets when VLA can exploit them and again this year we signed three new Licence Agreements with both diagnostic companies and vaccine manufacturers to extend our current portfolio to 15 licences.

All in all, this has been a very successful year for the Commercial Programme and VLA continues to hold its place as a major supplier of quality laboratory services to the UK animal health industry.

Business managers from VLA, the Defence Science Technology Laboratory, the HPA and our sister Defra agency the Central Science Laboratory, have developed a network which was recognised in January 2004 with an award of £1m over three years under the PSRE Capacity Building Fund to set up a strategic marketing group to identify and commercialise technology clusters across the partners’ business areas.

The Business Development unit continued to promote the whole Agency with the production of a wide range of marketing literature including the customer newsletter 'insight'. It also provided biological reagents sales to commercial customers and other institutes and supported the Agency at a number of exhibition venues.

VLA’s customer newletter 'Insight'

VLA’s exhibition stand at the Pig and Poultry Fair, Stoneleigh, Warwickshire

Test Development

The aim of this programme is to introduce and validate new tests into routine diagnostic use in order to maintain a modern, flexible test portfolio at VLA. Several projects have had an underlying theme of exploiting the use of robotics and real time polymerase chain reaction (RT-PCR) as a platform for the development of nucleic acid based tests suited to routine diagnostic use.

Kath Webster Head of the Biotechnology Department

A routine diagnostic RT-PCR assay has been developed to diagnose pathogenic Leptospires in kidney or urine samples. The advantage of this test is that a result is available within one day as opposed to the culture method, which can take up to six months to produce a result.

Similar technology has been used to develop another assay to test for the presence of bovine viral diarrhoea virus in tissue samples, particularly aborted material.

Investigations into the stability and batch-to-batch variations of RT-PCR reagents have shown that it is possible to freeze down whole assembled RT-PCR reactions without any deterioration in assay performance. As a result batches of PCR reactions can be stored and used as required, making routine testing and quality control much more straightforward.

Fimbrex diagnostic test kit

The practicalities and technical aspects of using internal controls as part of routine testing to enhance quality control is particularly important when working with clinical samples. Certain factors within the samples can inhibit PCR and lead to false negative results. Several approaches have been evaluated using a variety of assays and platforms and the data gained will be used to develop generic guidelines for the use of internal controls in diagnostic PCR.

A real time single tube RT-PCR assay for rabies virus has been developed using four different fluorescent labels to detect and genotype classical rabies, EBL 1 and 2 together with an internal control. The test has performed well in European ring trials and has important advantages over current PCR methods.

Two new methods, a Taqman® PCR and a method based on mass spectrometry, are currently being investigated to detect animal products in ruminant feed and the early signs suggest they will enhance the current testing systems.

A pilot study to develop and evaluate methods for the detection of Johne’s Disease in cattle faecal samples has also been undertaken.

Mycobacterium paratuberculosis - Johne’s Disease