Quantification of residual DNA from production strains or cell lines in biopharmaceutical and biotechnological products (residual DNA testing)

By Dr. Katrin Mansperger and Dr. Sven Hoffmeyer, Pharmacogenomics, Eurofins Medigenomix, Germany

Protein based diagnostics and therapeutics gain more and more importance. These molecules are produced utilising production strains and cell lines ranging from bacteria to mammalian cell lines. Biologicals like antibodies may be contaminated with traces of nucleic acids. This residual DNA or host cell DNA is derived from the production strains (e.g. bacterial strains) or cell lines and is usually co-purified during manufacturing and purification processes. Regulatory authorities allow only very little amounts of remaining host cell DNA in biologicals. Particularly, if genetically modified organisms are used, the amount of the production strain has to be quantified during the production and purification steps as well as in the end product. Highest accuracy and sensitivity can be achieved by quantitative Real-Time PCR targeting specific DNA targets of the production strain or cell line. The development and validation of such tests are key competencies at Eurofins Medigenomix in Ebersberg, Germany. Residual DNA testing is performed in an ISO 17025 accredited laboratory and according to GxP standards. This service is also offered at Eurofins Lancaster Laboratories in the US.

Contact: pharmacogenetics-eu@eurofins.com