Analytical Support

A key competence under-pinning our experience in the development and operation of recombinant protein processes is our analytical capabilities, from method development to stability testing.

Our comprehensive range of analytical services supports all of the key activities through the drug development process, including:

• Analytical development packages for the support of the development or refinement of manufacturing processes
• Design, testing and validation of cleaning methodologies
• Development, qualification and validation of test methods
• Characterisation of proteins, polypeptides and reference standards
• Design and execution of comparability studies
• Design, execution and reporting of forced degradation programmes
• Design of stability trials, storage and execution for drug substance, product and placebo materials
  

These activities are performed by dedicated analytical groups. An extensive range of techniques are employed, including:

• Chemical analysis techniques
• Separation science, range of chromatographic (HPLC and GC) and electrophoretic techniques
• Structural characterisation techniques - N terminal analysis, mass spectrometry
• Spectroscopy - UV/Vis, fluorescence, FT-IR, ICP, CD, DSC, particle size
• Biochemical - ELISA, bioactivity assays
• Further specialist knowledge and services (eg. LC-MS, CE, MS-MS, XRF, SEM) are provided by specialist audited partners