Pharmacokinetics Studies: Example results
Head-to-head comparison with ELISA
Comparison of ELISA and Gyrolab for the quantification of a monoclonal antibody drug, carried out by MedImmune, Cambridge, UK. Sample volumes, assay run time and assay development time were reduced dramatically, while precision was improved and dynamic range was increased by a factor of 10.
Comparison of assay performance as part of the CAT study.
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No assay drift
Quotient Bioresearch, Fordham, UK, had concerns about assay drift across the plate in their current, plate-based technology and wanted to ensure that Gyrolab did not suffer from the same type of drift across the CD. A total of 24 replicates of the QC sample were run across the CD and all fell well within the acceptance criteria range, without any indication of drift across the CD.
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PK evaluation using clinical samples
Clinical sample data from a PK evaluation performed by MedImmune, Cambridge, UK. Drug was administered to subjects at three time-points with subsequent sampling. The resulting distribution of data is exactly as would have been expected with the manual assay.
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Target quantification: Changing CD decreases limit of detection
In a dynamic range comparison, standard curves for human MIP-1β were prepared using Gyrolab 200 and Gyrolab 1000 respectively. The increase in sample volume from 200 to 1,000 nl results in a higher signal with no significant increase in background. Thus, with the introduction of Gyrolab 1000, the dynamic range of the assay was shifted towards lower concentrations, decreasing the limit of detection by a factor of four.