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)
- 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.