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. |