Analysis of biopharmaceuticals in biological samples from pre-clinical and clinical studies is an important part of the drug development process. The Bioanalytical division at Huntingdon Life Sciences is an operational grouping responsible for new technologies to assist with drug discovery and development.
Knowledge of the pharmacokinetics (PK) of a product in humans and animals is important in choosing dose levels and regimens as well as in assessing safety margins and the relevance of extrapolating toxicological data to humans.
For biopharmaceuticals, PK and Pharmcodynamic (PD) data are particularly critical as the suitability of the species selected for toxicological evaluation depends not only on the expression of pharmacological activity and low antigenicity in that species but also on the PK.
Working closely with the Pharmacokinetic department we can offer integrated reports containing bioanalytical data together with PK evaluation and interpretation, customised to meet individual requirements. The department of clinical bioanalysis can also handle large numbers of samples from multi-centre international clinical trials (Phase I - III) to GLP regulations. Robotic samplers are available to facilitate sample throughput.
- Immunoassay to detect monoclonal antibodies (mAbs) and recombinant proteins
- Flow cytometry for detection of mAbs bound to blood cells (saturation analysis) and modulation of targeted antigen thereby complementing the plasma PK data
- Sandwich hybridisation assays and CE for detection of antisense products
- PCR, RT-PCR, ELISA, immunohistochemistry, in situ hybridisation and
Western blotting for detection of gene therapy vectors / DNA vaccines and
their expressed mRNA and protein products
- LC-MS/MS for detection of synthetic peptides
- Immunoassay to measure anti-product antibodies
- Bioassays to assess neutralising effect of anti-product antibody where
cell number or receptor expression are relevant PD markers
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