Residual DNA testing

Designed especially for companies in the biomanufacturing sector we offer testing for residual DNA during the production of bio-pharmaceuticals. We detect and quantify residual host cell DNA in validated assays for Echerichia coli, Saccharomyces cerevisiae, chinese hamster ovary cells, murine hybridoma and murine myeloma expression systems.

Other assays may be developed to serve the expression system of your choice, such as Pichia pastoris and N. tabacum.

Our service offers:

Assay design, including primer design and synthesis
Assay optimisation (quantitative PCR)
Standard assay performance
Assay verification and validation in accordance with ICH guidelines (discussed with you in detail)
Data analysis
Report writing – delivered in the format you require.
All of our services are performed according to BS EN ISO9001:2000.

We are reliable, responsive and cost effective. Please contact us now for discussion of your needs.

You may also like to consider our other services dedicated to the biomanufacturing sector.

DNA sequencing
Confirmation of plasmid sequence at different stages of the
bio-manufacturing process is vital. When your chosen clone has been made, we will prepare and archive the plasmid DNA and accurately sequence it to 1X, 2X, or 3X coverage as required.
Gene Expression studies
We can perform gene/protein expression studies on your samples of interest using a number of techniques, including quantitative PCR. You can then check for levels of gene expression at all stages of the scale-up and fermentation processes.

We will help you with the initial assay design and optimisation protocols and also work with you to validate your assays, if required, in accordance with ICH guidelines.

Full written reports are provided as part of our service along with supporting documentation according to your specific project requirements. All work is performed to BS EN ISO9001:2000.

We also offer services such as Residual DNA, Genotyping, Forensic Testing, Gene Expression and various other services. Please click here to contact us with your requirements.

We are reliable, responsive and cost effective.