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How to set up assays for HER2 expressing cancer cells

HER2/neu binding antibody trastuzumab

One of the major & established therapies targeting breast cancer is the HER2/neu binding antibody trastuzumab. It has improved the five-year disease free survival of stage 1–3 HER2-positive breast cancers to about 87%.

The patent protection of the originator product  Herceptin ® has expired in the EU in 2014 and the US in 2019. Since then biosimilars are making their way into the market.


VelaLabs provides a variety of assays using HER2/neu expressing cell lines

VelaLabs provides ADCC potency bioassays as well as anti-proliferation assays using different HER2/neu expressing cancer cells. The ADCC can be done either with PBMCs or in an reporter-gene-assay format.

Additionally binding assays on HER2/neu with SPR or flow cytometry can be set up.


Developing and qualifiying a sucessfull cell based ADCC bioassay requires extensive expertise

Key Parameters are:

  • selecting the right target cells
  • applying optimum incubations times
  • the right effector to target cell ratio
  • a robust readout

Furthermore any adaptions/modification in the Fc part of the antibody (e.g. Fucosylation,…) can influence the ADCC activity.

VelaLabs has tackled these challenges and can offer ADCC e.g. with SK-BR-3 cells, and can provide an assay with a 4PL dose response curve to calculate potency, or measure stability studies.

For comparability studies also reporter gene assays can be used. Therefore several kit options from different vendors are available – dependent on analytical needs.

For the binding analytic Fab or Fc part three qualified  T200 Biacores are available to measure the binding to HER2 ectodomain (Fab) or its effector binding site (Fc) by binding to FcR I – FcR III and FcRn. For the Fc part a fast track plattform is established. Also the binding to Fc part can be a prediction for the bioassay.


Get more information on trastuzumab HERE.
Get more information at the advanced breast cancer global alliance organisation HERE.


With our expertise in analysis and characterization of biomolecules our experts are looking forward to answering your questions. 

Contact us – we are looking forward to supporting your analysis needs  I   +43 189 059 7911.




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