Detection of DNA and RNA in Bio-Pharmaceuticals and other Products
Biopharmaceutical and other biotechnical products can be contaminated with traces of nucleic acids. Eurofins Medigenomix offers various analytical methods for the detection of such residual DNA.
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, qPCR, melting curve analysis und 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 ISO 17025:2005 accredited DNA-Laboratory.
For an overview of our Services in the area Pharma please visit the website of our Business Unit Pharma Services.
For further information please contact us:
