Direct MOA

Through our unique and bespoke assay design methodologies, Antibody Analytics offer solutions to complex cell-based potency assays, ranging from primary cell-based characterisation through to GMP-ready lot release analysis.

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Monoclonal antibody-based drugs have the unique capacity to recognise a targeted cell through its expression of key biomarkers. Using direct and indirect means, these antibodies modulate the cell's intracellular signalling pathways. mAbs have a broad range of potential mechanisms to carry out their therapeutic activity and these activities can be measured in a number of ways including:

Apoptosis analysis
Proliferation/ death analysis
Cytokine release
Signal Transduction

During the development of an in vitro biological assay to characterise the functional activity of a monoclonal antibody therapeutic several considerations should be taken into account:

Sensitivity of the assay to detect small changes in the biological function
Robustness of the method to day-to-day variability
Biological relevance of the approach

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