Secure the quality of your biotechnology products and optimize your production.
With the help of highly sensitive and quantitative methods residual DNA and RNA can be detected.
Biotechnological products can be contaminated with traces of nucleic acids derived from host cells. Hence, testing for residual DNA and RNA is important for risk assessment and approval.
Assessment and approval
Testing residual DNA and RNA is necessary for risk assesment and approval of:
With the help of residual DNA analysis you can secure that your products fulfill the regulations and guidelines of the EFSA, FDA, WHO or EMA.
Aims of the analysis
- Monitoring the production of antibodies to detect harmful contaminations of the production cells with viruses.
- Optimization of production and purification processes for protein-based diagnostic and therapeutic agents or food products such as amino acids or vitamins.
- Batch release according to the requirements of regulatory authorities and internal quality control.
Quality
All analyses are carried out by our ISO 17025 certified laboratory and on request according to GCP standards.
Contact us and discuss your project with our specialists.
The services can be mapped to every need your risk assessment requires - from quality assurance to determination of DNA clearance during the production process.
Examples for media from production lines to test for residual DNA:
- Raw material
- Different cleaning stages
- Final batch for release
Available Services
Profit from services comprising the development and validation of new assays as well as the application of existing ones.
Accuracy of detection:
- Genomic DNA on picogram level
- Bacterial DNA on femtogram level
- Detection of DNA from viral origin
Quality
All analyses are carried out by our ISO 17025 certified laboratory and on request according to GCP standards.
Contact us and discuss your project with our specialists.