Biological drugs provide some novel challenges for the design of potency assays for batch release and stability testing. Batch release may involve developing a bioassay to directly measure the biological activity of the drug, a surrogate assay (eg ligand binding assay) to indirectly measure biological activity or a multi-assay approach.

The assay must be designed specifically for the drug in question and be a biologically relevant measure of its potency. Cell based assays may also be prone to inherent variability due to the use of living material in the assay. Good assay design, execution and statistical analysis are vital for successful batch release assays.

BioAnaLab staff have experience of developing and performing cell based potency and ligand binding assays for the purpose of batch release and testing of stability samples. These assays can be performed to claim compliance to GMP for regulatory submission or as a non-regulatory study under the same high quality standards.

Depending on the nature of the assays, the data can be expressed as absolute values or by 4 or 5 parameter logistic parallel line determination.

We have experience using a wide range of cell based assays (e.g. ADCC, cell proliferation, receptor binding) and ligand binding techniques including (ELISA/EIA/RIA), surface plasmon resonance (BIAcore), electrochemiluminescence (ECL) and immunoblotting.