Cell Based Assays

BURECO established its cell culture facilities in 2006 and permanently expanded its activities within this challenging area over the last years.

Functional cell culture or cell binding assays are quantitative assays with an accuracy and precision approaching that of physico-chemical methods. These assays are used for the measurement of:
  • Biological activity or potency for release and stability testing
  • Neutralizing antibodies
Assay formats for cell based assays, which are offered by BURECO comprise eg:
  • Proliferation or proliferation inhibition assays
  • Second messenger assays
  • Reporter gene assays
  • Kinase receptor activation (KIRA) assays
  • Phospho-specific antibody cell ELISA (PACE)
  • Cell binding assays (cell ELISA).
Readout systems include UV/VIS spectrophotometry, chemiluminescence and fluorescence techniques.

These assays are required for release and stability testing of biopharmaceuticals, since the complex molecular structure of biopharmaceuticals cannot be described sufficiently by physico-chemical methods alone.

Assays may be performed according to protocols compliant with EU and U.S. GMP guidelines and can be applied for release and stability testing of active pharmaceutical ingredients and final products.

The same assay principles are applied to assess neutralizing antibodies against biopharmaceuticals, which can also be performed under GLP