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GMP Cell-based Bioassays and Potency Testing

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

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.

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)

Our expertise in complex method development and validation for potency or biologic activity assessment can give you detailed insight into your biologic, helping to accelerate your development process. We can additionally provide extensive protein structure analysis from the primary structure through to higher-order structure, post-translational modifications and glycosylation studies. Our protein physicochemical property determination services include molecular weight and electrophoretic, chromatographic and spectroscopic profiles. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.