Pharma Services Portfolio: Detection of DNA and RNA in Bio-Pharmaceuticals

Biopharmaceutical products can contain or 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. The limits of detection for genomic DNA are in the picogram (pg) range and for bacterial DNA it can be even much lower (down to a few femtogram). For comparison: 100 pg of genomic DNA in a product corresponds to approximately the amount of DNA contained in 17 CHO (Chinese Hamster Ovary) cells. 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
• Batch release according to the requirements of regulatory authorities like the European Medicines Agency (EMA).

All analyses are carried out by our ISO 17025:2005 accredited DNA-Laboratory.

For an overview of our services in the area 'Applied Genetics' please visit the website of our Business Unit DNA Forensics / Applied DNA testing.

Please contact us to discuss your project or your study in detail: pharmacogenetics@medigenomix.de