Residual DNA analysis

Residual DNA analysis

Search for traces

Eurofins offers various analytical methods for the detection of residual DNA

Biopharmaceutical and other biotechnical products (food, feed, chemicals) can be contaminated with traces of nucleic acids derived from genetically modified microorganisms. Hence, testing for residual DNA & RNA is important for risk assessment and approval according to guidelines and regulations:

  • For an approval of food and feed from the EFSA ((Regulation (EC) No 1331/2008 and 234/2011)) or the FDA ( 'Generally recognized as safe' (GRAS)), risk assessment is obligatory to determine the presence of residual recombinant DNA with the potential of a possibly happening gene transfer.
  • For an approval of biopharmaceuticals (pharmaceutical substances produced by biological hosts (bacteria, yeasts and eukaryotic cell lines)) the WHO guidelines and the EMA regulations accept 10 ng residual host cell DNA per parenterally administerd dose, whereas the FDA accept only 100 pg when the products derived from continious cells that are e.g. carcinogenic.

Eurofins as your partner, offers a broad range of genomic services giving you the possibility to check the safety of your products that subsequentley lead to product success on the market. These services can be mapped to every need your risk assessment requires - from quality assurance to determination of DNA clearance during the production process.

Strict confidentiality is ensured by every project. The high quality of our service is overseen by a professional quality management team. We are certified according to DIN EN ISO 9001:2008 and accredited according to ISO 17025:2005 (D-PL-13372-01-00). To complete this, we also offer residual DNA testing according to GxP regularies.

For further information or for discussion of your specific project, just contact us!