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As a regulatory requirement for the release of biological products onto the market, biological potency assays are of vital importance in the product development and manufacturing processes.


SGS potency assays services meet the regulatory requirements of FDA, USP, EP and ICH guidelines.

Our assays, conducted by experts in their field, measure the efficacy or effectiveness of biological drug candidates in an in vitro system, and we have developed specialist skills in method development, validation and transfer for two kinds of tests:

  • Cell-based assays – cellular processes such as cell viability or proliferation and cell death
  • Immunoligand-based assays – antibodies/ ligands, receptor ligands

We have a full range of potency assay test methods:

Cell growth assays

  • MTT assay
  • Trypan blue exclusion assay
  • Florescence microscopy
  • Flow cytometry

Cell death assays

  • MTT assay
  • Trypan blue exclusion assay 
  • Annexin V propidium iodine (apoptosis/necrosis)
  • TUNEL (Terminal deoxynucleotidyl transferase dUTP nick end labeling) for detecting DNA fragmentation

Binding assay

  • HTFR – high time fluorescent resolution

SGS is a world leader in testing solutions for quality control and risk management for biological products. Many clients across the globe already trust us to conduct their potency assays. Contact a consultant at one of our world-class laboratories to find out how we can help demonstrate the safety and efficacy of your biological products.