Cell Line Characterization

At SGS, we use a variety of nucleic acid and protein-based technologies to characterize the identity of cell lines and assess the structure of the expression construct. When we carry out a cell line characterization 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 characterization 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 Characterization Test Methods

• Isoenzyme analysis
• 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
• Culture method
• Indicator cell method
• PCR method
• Sterility testing
• Direct inoculation
• Filtration method
• Alternative qualified system: BactT/Alert 3D (sterility results obtained in 72h)
• Bacterial endotoxins testing
• Detection of Host residual:
• Generic DNA/RNA residual
• Host specific DNA residual
• HCP assay

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

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