Viral safety testing

Viral safety testing is key in the development and manufacturing of biologics. It’s a regulatory expectation and a critical safeguard for patient safety. While adventitious virus assays identify unexpexted contaminants, a complete viral safety strategy also addresses risks introduced by  raw materials, cell substrates, or manufacturing processes. 

Without the right approach, undetected viral contaminants can compromise your entire development program, delay market entry, or trigger costly recalls. 

At Clean Cells, we design viral safety services strategies combining:

  • molecular methods (PCR, qPCR) for rapid and sensitive detection, 
  • species-specific cell lines for targeted assays, 
  • transmission electron microscopy (TEM) for morphology-based virus identification. 

Based on thorough risk assessment (scientific literature and expert knowledge), we identify the most likely viral families and species to be present and target them with dedicated assays.

GMP-compliant viral safety testing expertise

With over 20 years of experience supporting both pharmaceutical and veterinary industries, Clean Cells provides GMP-compliant viral safety testing tailored to biologics and gene therapy development. 

Our expertise includes: 

  • Hundreds of PCR assay references covering a wide range of species.
  • Customized viral safety strategies: designed according to product type and risk profile. 
  • Gene therapy viral safety: dedicated assays for rcAAV (replication-competent AAV) and RCL (replication-competent lentivirus) to evaluate potential recombination risks. 

 

Viral Safety Testing - PCR - qPCR - TEM - NGS

Comprehensive Viral Safety Testing Services

Our portfolio of assays, ensures full compliance with EMA, FDA, and ICH Q5A regulatory guidelines: 

  • PCR assays: extensive catalog covering human, bovine, porcine, murine, avian, equine, caprine/ovine, simian, insect, feline, and canine viruses
  • Bovine and porcine viral safety evaluation: broad selection of permissive cell lines combined with PCR assays for the detection of specific contaminants
  • Retrovirus detection: indicator cell line assays, QPERT (reverse transcriptase activity), and TEM
  • Transmission electron microscopy (TEM): performed in collaboration with expert partner
  • Gene therapy viral safety: rcAAV and RCL assays to ensure vector safety
  • R&D or GMP-compliant services: to match evolving needs throughout the development phases 
  • Custom analytical development: design and validation of customized PCR assays

Clean Cells: your trusted partner in viral safety

Choosing Clean Cells, means increasing confidence and avoid risk in late-stage development. You gain access to: 

  • 25+ years of expertise applied to biologics and ATMPs,
  • Proactive regulatory alignment: to anticipate evolving expectation from authorities (EMA, FDA…),
  • GMP standards service alignment to secure your biologics and gene therapy products,
  • A one-stop-shop covering  viral safety assays, additional QC testing and cell & virus banking,
  • Dedicated scientific support, to co-build the right viral safety strategy for your QC program.

Contact our experts to build a compliant and secured viral safety strategy for your biologics development. 

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