Quality Control TestingPotency

Potency testing at R&D, clinical and commercial stages

Clean Cells owns a Good Manufacturing Practises (GMP) license for the quality control testing of biological products at clinical and commercial stages.

As part of these operations, potency evaluation is of utmost importance, notably through a portfolio of cytotoxicity assays intended for monoclonal antibodies and Advanced Therapy Medicinal Products such as CAR-products (Chimeric Antigen Receptor T cells).

These methods may be used for candidate screening (R&D, non-regulatory) or release testing (clinical or commercial stages) and include :

Monoclonal antibodies

Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) assay

Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) assay

Effector function: innovative standardized effector cell line or PBMCs

Read-out: High-performance luminescence-based method or Chromium 51

All combinations of the above methods can be applied for a bespoke ADCC assay.


Potency assays using the high-performance luminescence-based method

Other potency methods

  • CDC assay (Complement-Dependent Cytotoxicity)
  • Telomerase testing
  • Interferon testing, etc.

Please reach out to the team for additional information or to discuss bespoke assay development.