Cell Based Bioassays

Confarma offers analyses using a large variety of cell types according to GMP, CGMP (FDA), GLP and ISO 17025 standards. Depending on your requirements, we can develop, transfer or validate your product-specific assay and guarantee that your assay is performed according to the current quality control guidelines. We have also several “off-the-shelf” assay systems ready for testing.

Our product-specific assay portfolio contains:

  • Potency assays with cytokine-readout
  • Potency assays with proliferation readout
  • ADCC surrogate assays using reporter cells
  • Method development/transfer including establishment of a cell bank on site
  • Method validation according to ICH Q2R1 or USP chapter

Cell based routine assays implemented at Confarma:

  • Cytotoxicity assays
  • Assays for genotoxicity
  • Pyrogen detection with the monocyte activation test (replacement of the pyrogen test on rabbits)