According to ICH guideline Q6B, potency is the measurement of biological activity using a suitable quantitative biological assay (also called potency assay or bioassay) based on the attribute of the product which is linked to the relevant biological properties. Binding assays (immunoassays) can also be used as surrogate assays for biological activity assessment.
During the development of a biopharmaceutical product, the potency assay is considered as essential to quantify the biological effect of the product. All the analytical results obtained for a therapeutic protein have to be correlated with the bioassay results.
Potency assays should follow the life of the product during characterisation, stability studies and GMP batch release testing.
Quality Assistance is specialised in the development and/or optimisation, validation and transfer of a very wide range of potency assays. Analytical work is performed in a GMP-compliant environment according to the sponsor’s requirements.