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!
Search for traces
Our services comprise the development and validation of new assays as well as the application of existing ones.
Depending on the project and its demands applications are used which are based on PCR and/or hybridisation methods, such as
- direct PCR
- melting curve analysis
- direct sequencing
With few molecules the limits of detection for genomic DNA are in the picogram range and for bacterial DNA it can be even much lower (down to femtogram range). The assays also enable the detection of nucleic acids of viral origin.
For monitoring of production processes samples can be taken at the different steps of the production line, e.g. from cleaning stages. The information gained through the DNA & RNA detection analysis can be very valuable and important for the optimisation of the production process.
Aims of the analysis are typically:
- Monitoring of the production of e.g. antibodies to detect detrimental contaminations of the production cells with viruses
- Optimisation of production and purification processes (upstream / downstream processing) for e.g. protein-based diagnostic and therapeutic agents or food products such as amino acids or vitamins
- Batch release according to the requirements of regulatory authorities and internal quality requirements.
All analyses are carried out by our DIN EN ISO 9001:2008 certified and ISO 17025:2005 (D-PL-13372-01-00) accredited DNA-Laboratory and can also be performed in compliance with GxP regularies.
For an overview of our services in the area Pharma please look here.