Quality Control TestingPotency

Clean Cells is able to propose several methods for potency evaluation of several products

Cytotoxicity

Monoclonal antibodies

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.

CAR-T

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.

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