Clean Cells is able to propose several methods for potency evaluation of several products:
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
- Telomerase testing, interferon testing, etc.
- Bespoke cell-based assays can be developed and/or validated ( ICH Q2R1) upon request for the evaluation of various biologics.
These assays can be used for early candidate screening or as regulatory-compliant release testing of your product.