Binding and Cell Based Potency Assays
The potency of a therapeutic biologic is most commonly determined using a cell based bioassay and is frequently supported by a complimentary binding assay that is based upon the primary mechanism of action (MOA) of the therapeutic. Such methods play a critical role at all stages of product development and are essential tools that are employed during clone selection, process development and optimisation and will ultimately feature as the most critical of the lot release assays.
The importance of getting the method correct cannot be overstated and considerably attention should be applied during development to ensuring that robust methods are built in line with best practices, provide consistent, accurate and precise results over time and are stability indicating. With a comprehensive knowledge of the bioassay requirements across clinical phases and therapeutics classes, Antibody Analytics offers a range of best-in-class binding and cell based assays to characterise biosimilars using QuBas Bioassay Software and can apply our expertise to develop high quality potency methods for novel therapeutics.