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About us

The Spectratox Team

Key members of our team have more than 20 years’ experience embracing patient phototoxicity and all aspects of conducting phase-1 laboratory studies and phototoxicity trials. The team has a proven track record of working with more than 20 new molecules using the human volunteer method.

Professor James Ferguson MD, FRCP, is a renowned academic and clinician with significant publications in the areas of drug-induced phototoxicity, phototherapy, photochemotherapy and the photodermatoses. The publications embrace the clinical and laboratory study of drug-induced phototoxicity, particularly concerning the fluoroquinolones, and the natural history and treatment of the photosensitivity disorders. Professor Harry Moseley PhD. provides essential photophysics expertise.

The experienced staff at Spectratox offers a seamless service combining expertise in pre-clinical laboratory data analysis with the ability to perform volunteer studies and additional post-study scientific testing or research as necessary. If test results are positive, the team can offer advice on product labelling and clinical management.

Photophysics

All of the work carried out by Spectratox is underpinned by strict adherence to quality control. All protocols and procedures are carefully documented and controlled. Work carried out by the National Photobiology Unit provides quality assurance by operation to ISO 9001 standards.

Equipment used by Spectratox has been designed and built according to our own specification, relying on our many years of experience of drug photo-testing allied to our knowledge of the latest developments in optics.

Knowledge of the light dose administered to subjects during testing is fundamental to the reliability of the results obtained. The team at Spectratox has an international reputation in the field of UV light measurement. All measurements are traceable to the National Physical Laboratory, which is the UK’s National Measurement Institute.

Calibrations are performed in-house in an optical radiation laboratory accredited by the United Kingdom Accreditation Service (UKAS). Accreditation by UKAS demonstrates competence, impartiality and performance capability of the laboratory.

At Spectratox, we place a high value on dosimetry – the science of accurate measurement. The result of this background activity may be summed in one word, “Confidence”.

In-Vitro Phototoxicity Testing & Drug Development

Our aim is to work in partnership with our customers to provide a flexible approach to phototoxicity assessment and data interpretation in concordance with current regulatory guidelines (EMEA; FDA). Phototoxicity may be an issue for compounds that absorb UV and/or visible radiation and are applied topically, or accumulate in the skin following administration by other routes (eg. systemic route).

Conversely, our approach can be used in the investigation of the efficacy and ‘dark’ safety of photoactivated therapeutics under development.

We can provide:

• Spectral analysis and photostability studies

• Phototoxicity assessment: The ‘workhorse’ assay for in-vitro photoxicity assessment is the neutral red uptake phototoxicity assay. Spectratox can also offer supplementary assays including the photo-micronucleus assay, photo-comet assay and investigation of protein expression. Compounds can be tested in different model systems including simple monolayers; 3D co-cultures and spheroid cultures; skin equivalent models.

• Assessment of DNA reactivity: This can be an important issue for compounds that are altered by light (or their photoproducts). Model systems range from plasmid DNA to the photo-comet and micronucleus assays. Base modifications and crosslinks are identified indirectly via enzyme activity and immunofluorescence staining.

The cell culture laboratory operates to the highest standards of aseptic technique. Cells are maintained in antibiotic-free conditions and regularly checked for the presence of mycoplasma. All experiments are quality controlled and archive QC data is available for a range of cell lines useful not only for skin research, but also for the development of photoactivated therapeutics targeted to other tissues.

 

Web Site Launched

18th April 2008