Viral safety testing

Complementary to non-specific adventitious virus testing, viral safety testing is a section of biosafety testing which aims at revealing the presence of characteristic agents with molecular (PCR) methods, species-specific cell lines and transmission electronic microscopy (TEM). Risk assessment based on literature and expertise singles out families and species of viruses that should be searched through viral testing assays. Raw material used during culture (eg. serum) can be the source of characteristic contamination (eg. bovine and porcine) while some cell lines may carry specific viruses or endogenous retroviruses.

 

Through extensive collaboration with the veterinary industry, Clean Cells has built market-leading viral safety testing services applicable to GMP requirements. With hundreds of PCR assay references, Clean Cells is able to build bespoke safety strategies. Additionally, Replication-competent Lentivirus (RCL) and Replication-competent AAV assays (rcAAV) are available for gene therapy drugs which may carry a risk of recombination and should be evaluated by viral safety testing.

  • Hundreds of PCR tests for human, bovine, porcine, murine, avian, equine, caprine/ovine, simian, insect, feline and canine viruses
  • Bovine and porcine viral safety evaluation (serum-grown cells): extensive list of permissive cell lines and PCR tests for specific detection of bovine and porcine contaminants 
  • Retrovirus detection: indicator cell line testing, QPERT (reverse transcriptase assay) and TEM
  • One-stop-shop solution for integrated viral safety testing : microscopy evaluation carried out by our expert partner
  • rcAAV and RCL assays for gene therapy vectors safety testing
  • R&D or GMP-compliant
  • Bespoke PCR development through analytical development
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Reach out to us if you wish to discuss viral safety analytics needs or customized development.

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