Residual DNA Testing

During or after production of bio pharmaceuticals, recombinant protein or DNA frequently needs to be tested for residual, contaminating bacterial or mammalian DNA.

Using the ABI PRISM 7900HT QPCR platform upgraded with the Sequence Detection System or our custom target-specific assay or total DNA Threshold™ System, DNAVision SA can quantify residual DNA with optimized assays or can develop assays specific to client’s targets. These methods encompass the entire range of residual DNA from unspecific detection of total DNA to the highly specific detection of single target sequences.

Benefits of DNAVision SA’s residual DNA testing service include:

ISO17025 accredited laboratory (Belac 351-T)
GLP compliant services (21 CFR, Part 58; certification process in progress)
cGMP for Finished Pharmaceuticals (21 CFR, Part 211) compliant services
If extractions need to be performed, we optimize the extraction procedure for the customer sample by spike tests and perform superior quality DNA extraction.
Know-how and experience with sample purification and preparation enable us to analyze a wide range of matrices: Escherichia Coli, Saccharomyces cerevisiae, chinese hamster ovary cells, murine hybridoma and murine myeloma expression systems, human genomic DNA.
Detection of <200 fg/reaction
Excellent service for small or large projects

Sample Requirements

The client will provide:

biological samples: bulk product, protein or swabs
control samples: purified plasmid DNA and host genomic DNA

Results

All reports are available via email or mail. The Final Report includes a description of the overall project design and raw data.

For QPCR determination: Output from the ABI 7900HT System (experimental reports, standard curves, and amplification plots), and determination of the Ct (amplification threshold value) for each sample.

For Threshold™ determination: Output from DNA Threshold System from Molecular Devices, dDuplicate reactions are reported individually along with the sample mean and variation. For regulated projects, all working steps in the process flow are documented and filed. Raw data is archived over five years. Documentation and certificates are produced by the quality assurance department.