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Potency Testing

Potency Testing

The effective potency of the therapeutic, whether it is a protein, a vaccine or other molecule, needs to be demonstrated for each batch prior to its release. This is typically done in cell based assays, using reporter markers to verify that the batch induces the correct pathways.

Eurofins BioPharma Product Testing Netherlands can support you in performing novel or existing potency assays to demonstrate the efficacy of your therapeutic compound. We offer both Binding Assays and Cell-based Assays to characterize biological activity.

Full GMP certified execution of Biochemical Assays provides you with results that you can trust. Talk with our experts to see the range of solutions and detection systems that we have available; developed from scratch, or transferred using validated methods.

 

Binding Assays

  • ELISA
  • Surface Plasmon Resonance (SPR)
  • Fluorescence Resonance Energy Transfer (FRET)
  • Homogeneous Time Resolved Fluorescence (HTRF)
  • Colorimetric
  • Chromatography; HPLC, SEC-MALS
  • Electrophoretic techniques; CE; IEF
  • Mass spectrometric assays
  • Carbohydrate analysis
  • qPCR

 

Cell based Assays

  • Proliferation Assay
  • Apoptosis Assay
  • Cytotoxicity Assay, ADCC and CDC Assays
  • Cellular binding Assay
  • Viral Vaccine infectivity assay
  • Monoclonal binding assay
  • EPO potency assay

 

Assay Readouts

  • Absorbance
  • Fluorescence/TRF
  • Luminescence
  • Fluorescence activated cell sorting (FACS)
  • Surface plasmon resonance (SPR)

 

What products should be tested?

  • Protein based therapeutics
  • Biosimilars
  • Monoclonal antibodies
  • Vaccines
  • Gene Therapy products

 

Comprehensive Services to Support Biosimilars

Our comprehensive offering of testing services enables  us to support all aspects of your biologics development project, including:

Contact us if you would like to know more.

 

Why choose Eurofins BioPharma Product Testing Netherlands

  • Great flexibility. Our focus on small scale projects allows all flexibility you need.

  • Single-point-of-contact. With a wide array of services internally available, all communication is centralized.

  • Complete service portfolio. Many additional chemical, microbiological and ancillary services performed in GMP certified, WHO prequalified and FDA approved labs.

  • Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.

If you want to discuss your project or request a quotation, feel free to contact us.