Intertek is the industry leader with over 42,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
Tailored cell-based bioassay or potency assays for biologics and biosimilars to meet the requirements of ICH Q6B and Good Manufacturing Practice (GMP)
GMP cell-based potency testing quantitatively determines the biological activity of a biopharmaceutical. Measurement of potency plays an essential role in quality control, GMP product release and biopharmaceutical stability testing for both drug product and drug substance. Biological activity or potency is a critical quality attribute that often faces increased scrutiny by regulators over other types of test. The method/type of potency test employed is specific to the mechanism of action (MOA) of the biologic being studied and to meet the requirements of regulatory submissions, the potency assay should be validated to ICH Q2 (R1) standards.
Our potency testing experts offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1) standards via an array techniques including cell-based assays, ligand and receptor binding assays and flexible multiple assay approaches. Through this tailored approach, we maximize the efficiency of study design bringing cost-efficiencies and time-saving benefits. We also conduct routine potency release testing to GMP standards. Our experts work closely with you to provide a fully validated potency assay for your biologic, suitable for regulatory submission, which will perform reproducibly throughout the whole drug development process.
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.
We also apply Surface Plasmon Resonance (SPR) to measure product binding to its intended target and is particularly useful during product characterization, in particular for biosimilars as part of the comparability study to the innovator product.
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.