Biological Process >> Cell Banks >> Cell-line Characterization

Cell-line Characterization

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Eurofins BioPharma Product Testing Netherlands offers a range of assays to qualify cell banks in the biopharmaceutical production process. This includes cell line authentication and purity tests to ensure that your cell line is pure and free of contaminants.

Is your cell bank free of contaminants?

Eukaryotic and prokaryotic cell banks represent enormous potential value over the lifetime of the product. Therefore, international guidelines require that the cells should be qualified according to stringent standards prior to their release for use.

With years of experience and as a GMP/FDA/WHO-(pre)qualified lab, Eurofins BioPharma Product Testing Netherlands is an excellent partner to make your production process compliant to international guidelines. 

What products should be tested?

Eurofins BioPharma Product Testing Netherlands provides testing and qualification solutions for prokaryotic and eukaryotic:

  • Cell lines
  • Master Cell Banks (MCB)
  • Working Cell Banks (WCB)
  • Virus seed stock
  • Raw materials and final products
  • End-of-Production Cells (EOPC) or Post Production Cell Banks (PPCB)

Standard ICH-compliant assays for Eukaryotic Cell Banks

  • Sterility testing
  • Mycoplasma testing
  • Identity testing
  • Retrovirus testing
  • Bovine/Porcine assays
  • Specific virus assays
  • In vitro testing
  • In vivo testing
  • Electron microscopy analysis
  • Customized testing packages

Standard ICH-compliant assays for Prokaryotic cell Banks

  • Monosepsis / Purity test
  • Bacteriophage detection
  • Infectious titer and viability test
  • Identity by sequencing
  • Genetic stability test
  • Retention of selectable markers
  • Retention of recombinant construct
  • Copy number determination
  • Restriction map analysis
  • DNA sequencing
  • Customized testing packages

Custom services are available. Contact us to find out whether we can help. Our research team will be happy to assist in planning your study.

Why choose Eurofins BioPharma Product Testing

  • Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertise within the same organization, allowing clear and reliable communication.
  • All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multidisciplinary organization.
  • Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions.