Life Sciences Molecular Biology Services
Molecular biology services from SGS – retrovirus testing and lot release testing to ensure that the biological starting materials and mammalian cell substrates used in your drug products are free from contaminating viruses.
Quality control and lot release testing of drug products is a critical part of your biological manufacturing process. Our molecular biology services help you to ensure that final products derived from continuous mammalian cell lines contain acceptable levels of residual host cell DNA (HCD). We can also help you to ensure that biological starting materials and mammalian cell substrates are free from contaminant viruses, including retroviruses.
Why choose Molecular biology services from SGS?
We can help you:
- Comply with relevant guidelines. Our residual host cell DNA (HCD) assays are validated to International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q2 guidelines
- Meet the required specifications and gain detailed qualification studies with the relevant HCD assay required for your drug products. Our lot release testing is compliant with current good manufacturing practices (cGMP)
- Detect retroviral activity. Our retrovirus testing uses product-enhanced reverse transcriptase (PERT) assays, including a cellular DNA polymerase suppressant termed calf thymus DNA for high sensitivity to ensure specific detection of retroviral reverse transcriptase (RT) activity. Our retrovirus testing includes:
- Quantification of RT by quantitative real time fluorescent product enhanced reverse transcriptase (qPERT) assay
- Detection of RT by real time fluorescent product enhanced reverse transcriptase (FPERT) assay. This provides highly sensitive qualitative fluorescent results required for vaccine seed or bulk produced in human cell substrates
- Detect species-specific viruses, such as porcine circovirus and vesivirus, with quantitative real time polymerase chain reaction (qPCR)
- Detect Mycoplasma with qPCR
- Gain effective identity testing with isoenzyme and randomly amplified polymorphic DNA (RAPD)
- Conduct genetic stability testing
World leading molecular biology services
With our extensive knowledge of assay development and sample processing, we are one of the leading providers of services to the biopharmaceutical industry. Our molecular biology experts were the first to publish the Nucleic Acid Amplification Technology (NAT) validation and assay control system currently recommended in the European Pharmacopoeia 2.6.21 and 2.6.7.
We have developed and validated in excess of 100 species specific qPCR assays, covering viral pathogens from human, murine, simian, porcine, insect, duck, avian and bovine species. As a result, you can trust our experience and expertise.
Each of our scientists offers at least 10 years’ experience, setting the current biopharmaceutical industry standards for the development and validation of platinum-grade, high-throughput qPCR assays. We also provide US and European Pharmacopoeia (PH. Eur.) regulatory compliant assays for a wide variety of applications.
To find out more about our molecular biology services, contact us today.