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At SGS, we use a variety of nucleic acid and protein-based technologies to characterise the identity of cell lines and assess the structure of the expression construct.

When we carry out a cell line characterisation test, you will benefit from our high quality facilities and expert personnel to ensure the safety of your biopharmaceutical product.

Using cell lines to produce recombinant protein products requires that, according to ICH guideline Q5B, “The characterisation of the expression construct and the final purified protein are both important to ensure the consistent production of a recombinant DNA derived product.” The analysis should “establish that the correct coding sequence of the product is incorporated into the host cell and is maintained during culture to the end of production”.

Cell Line Characterisation Test Methods

  • Gene and plasmid copy number assay
  • Flow cytometric analysis (FACS Canto II)
  • Histocompatibility antigens
  • Southern blotting
  • DNA fingerprinting
  • DNA sequencing (in partnership with DNA Vision)

Biological Safety Testing

  • Adventitious virus assay (ICH Q5A)
  • Specific virus/bacteria detection by qPCR
  • Virus titration by Plaque assay
  • Hemaglutination/haemadsorption assay
  • Mycoplasma testing according to the Eur. Ph. 2.6.7 and the FDA guideline
  • Sterility testing
  • Bacterial endotoxins testing
  • Detection of Host residual:

Contact SGS today to learn how we can help with your cell line characterisation testing.