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HomeLife SciencesBiopharmaceutical ServicesLaboratory ServicesBiopharmaceutical Product CharacterizationCell Line Characterization
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”.
Contact SGS today to learn how we can help with your cell line characterization testing.