Potency Assay

“Determining the biological activity of cell based immunotherapy products is not easy since the active ingredient is usually composed of whole cells and the activity of these products can generally not be attributed to one specific cell characteristic. The potency (i.e., the quantitative measure of biological activity) of cell based products can be measured using in vivo or in vitro tests. An appropriately validated potency assay should be based on a defined biological effect as close as possible to the mechanism(s) of action/clinical response.” (EMA/CHMP/BWP/271475/2006 rev.1)

Texcell is developing or transferring custom bioassays with several readout possibilities:

  • In vivo on small animals
  • In vitro in cell lines or primary cells

Results are computed according to the parallel line method (US/European Pharmacopoeia).

Bioassays are used for various purposes, such as:

  • Proof of concept
  • Neutralizing potential of unwanted antibodies against biologicals (ADA);
  • Potency assays for batch release and stability testing

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