Residual DNA Testing
Residual DNA or Host Cell DNA can be a contaminant present in biologicals that are co-purified with drug substances. These types of DNA can have negative effect therefore manufacturers of biologicals must ensure that the final products derived from continuous mammalian cell lines contain acceptable levels of host cell DNA.
Residual DNA testing ensures your drug’s final dosage form meets the requirements as established by the World Health Organization (WHO), the European Pharmacopeia, the US Food and Drug Administration (FDA), and other regulatory agencies. Therefore, we recommend testing for traces of DNA during:
Our global team of experts have experience of performing residual DNA testing on a wide range of samples including monoclonal antibodies, recombinant protein and viral products produced in cell culture. To meet your needs for Residual DNA testing we offer services including:
- DNA Extraction
- Extraction efficiency
- Ultra-sensitive detection of genomic DNA from multiple species
(E. coli, Mouse, CHO cells, Yeast (Pichia), Canine and Vero cells)
- Detection of human genomic DNA
- High throughput capacity assays
Contact an expert about your Residual DNA testing needs.
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