GMP Cell-based Bioassays and Potency Testing

Cell-based assays determine the relative potency of a product by comparing the biological response/activity, related to its mode of action, with a control/reference preparation (USP, WHO or in-house reference standard). This allows the product’s efficacy and ability to achieve a defined biological effect to be quantified. We apply a range of cell-based assay models to characterize recombinant proteins/ monoclonal antibodies: Cell migration assays Cell signalling assays Cell proliferation/inhibition assays Binding and/or competitive assays Ligand and Receptor Binding Assays Enzyme Linked Immuno-Sorbent Assays (ELISA) allows direct measurement of the biologic’s affinity to its target with typically, a robust performance. Flexible, Multiple Assay Approaches for Monoclonal Antibodies For products which have multiple MOAs, multiple assays may be needed to sufficiently demonstrate product efficacy as well as lot-to-lot comparability. We apply flexible approaches from an array of cell based assay platforms/models, as well as physico-chemical assays to designing potency assays for monoclonal antibodies and/or antibody drug conjugates (ADC’s) in order to assess their multiple MOA. GMP Cell-based Assays or Potency Assay Applications We apply phase-appropriate potency testing to wide array of biologic products including biosimilars, peptides, monoclonal antibodies, growth factors and cytokines and applications, such as biopharmaceutical stability testing and biologic drug product release testing. Candidate selection Assessment of clinical efficacy Product characterisation Robustness testing/design Biopharmaceutical stability testing Degradation products Formulation changes Support for production alterations Process intermediates characterisation Reference standard qualification Biologic product release testing Optimisation and transfer of assays Tracking and trending (establishment and maintenance of assays) https://www.intertek.com/pharmaceutical/biopharmaceuticals/