Livogen Pharmed Copmany

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Viral Safety Analysis Service (For MCB, WCB and EOPC banks):

The risk of viral contamination is a characteristic frequently happening to all biotechnology products derived from cell lines. Such contamination could have serious clinical consequences and can arise from the contamination of the source cell lines themselves (cell substrates) or from adventitious introduction of virus during production. Livogen offers viral detection service in accordance with the accredited regulatory requirements (ICH, WHO, FDA regulatory organizations).

The viral detection assays include:

  • Nucleic acid detection method

PCR primers can be directed against variable regions of viral nucleic acids in order to make sure the detection of specific viruses, or against conserved regions of viral sequences shared among strains or within a family in order to increase the chance of detecting multiple related viruses. Livogen offers quantitative PCR tests designed to detect adventitious and endogenous viruses in MCB, EPC, bulk harvest, and raw materials including EBV, HBV, HCV, HHV-8, HIV-I, HTLV-I/II, SMRV,…

  • Retroviruses assay

Following tests are applies to MCB, EPC, and the Bulk Harvest:

  • Infectivity assay in sensitive cell cultures

Direct and extended (Mink or Feline)S+L- assay

  • Transmission Electron Microscopy (TEM)
  • Detection of retroviral reverse transcriptase enzyme (F-PERT assay)

Following assays will become available in the near future:

  • In vivo assay

Samples from the MCB and EPC should be inoculated into animals including:

  •  Suckling and adult mice
  •  Embryonated eggs
  • Guinea pigs
  •  Rabbits

The animals are observed for at least 4 weeks for sickness or abnormality; viral identification may involve culture and/or molecular methods.

The eggs are examined after not fewer than 5 days of incubation.Examination of allantoic fluids for the presence of haemagglutinins, and embryos for survival are carried out.

  • In vitro assay

Samples from the MCB, EPC and bulk harvest should be inoculated into indicator cell cultures including:

  •  Human cells
  •  Primate cells
  •  Cells that are representative of the species and tissue type of the production cell line

Detection methods include:

  • Light microscopy
  • Haemadsorption and hemagglutination assay on monolayers

Viral Safety Testing

  • Mouse, hamster and rat antibody production (MAP, HAP, RAP) test

  • In vivo Detection of Adventitious virus assays 
  • - 14 and -28 day in vitro Detection of adventitious agent assays
  • Porcine and bovine advertitious agent assays
  • Retrovirus detection assays
  • Viral specific qPCR
  • Customized assays addressing specific
  • contamination risks

Retrovirus detection

  • XC Assay for Ecotropic Retroviruses

  • S+ L-Assay for Xenotropic Retroviruses

  • Electron Microscopy

  • Co-cultivation assays (murine, ecotropic, amphotropic and rodent)

  • PCR-based reverse transcriptase assay