Residual DNA or Host Cell DNA can be present as contaminants in biologicals that are co-purified along with drug substances. Because residual DNA can have negative effects, manufacturers of biologicals must ensure that final products derived from continuous mammalian cell lines contain acceptable levels of host cell DNA (< 100pg/therapeutic dose).
BioReliance performs residual DNA testing on a wide range of samples including recombinant proteins, monoclonals, and viral products produced in cell culture. We recommend testing for traces of DNA at the following stages of production:
- Raw Material Testing
- Bulk Lot Release Testing
- Final product release testing
Residual DNA testing ensures your drug's final dosage form meets regulatory guidelines as established by the World Health Organization (WHO), the European Pharmacopeia, the US Food and Drug Administration (FDA), and other regulatory agencies.
The BioReliance research staff has broad experience in residual DNA testing and is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample integrity.
Click here to contact a BioReliance scientist to learn more about the residual DNA testing services that are right for your project needs.
What residual DNA testing services do you provide?
The BioReliance CRO team offers highly sensitive residual DNA testing services to quantify residual host cell DNA during manufacturing and in final products including:
- DNA extraction
Ultra-sensitive detection of genomic DNA from multiple species (E. coli, Mouse, CHO cells, Yeast (Pichia), Canine and Vero cells)
Detection of human genomic DNA
- High throughput capacity assays
Custom assay development services also are available for specialized residual DNA studies - click here to learn more about our custom assay services or contact us today.
What methods do you use to quantitate residual DNA ?
After DNA extraction from test articles, we first ensure the sample is free of inhibitors using a straight-forward qualification assay.
At the base level, the BioReliance CRO team utilizes qPCR with standard primers to the host cell type genomic DNA to detect and quantify any contaminating residual DNA. As a general rule, 100 pg/dose is the upper limit for acceptable host DNA in biologicals.
For more specialized studies, we can employ the Roche / 454 Life Sciences™ Genome Sequencer™ FLX to provide MP-Seq™ (Massively Parallel Sequencing, i.e. “next generation” sequencing) services. Through the development of proprietary algorithms for sequence analysis, we have adapted this platform to use for drug manufacturing and production services, including residual DNA analysis.
For information on sequencing technologies used in residual DNA testing, click here.
Learn more about our Residual DNA services, by using the search tool to the right or click here.