Cell Line Characterization
Source: SGS Life Sciences Services
SGS' Life Science Services uses a variety of nucleic acid and protein-based technologies to characterize identity of cell lines and assess the structure of the expression construct.
SGS' Life Science Services uses a variety of nucleic acid and protein-based technologies to characterize identity of cell lines and assess the structure of the expression construct.
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
- Histocompatibility antigens
- Southern blotting
- DNA fingerprinting
- DNA sequencing
- Quantitative PCR
- Safety testing by search for infective adventitious agents (viral, bacterial, fungal or mycoplasmal)
- Tumorigenicity testing
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