Cell Line Characterization

Eurofins Sinensis 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 Sinensis is an excellent partner to make your production process compliant to international guidelines. 

What products should be tested?

Eurofins Sinensis 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)

Customized testing packages

Eurofins Sinensis offers specific testing packages for Master- and Working Cell Banks and End-of-Production Cells. These packages can be designed for your situation and typically include some or all of the tests below. 

Standard ICH-compliant
Eukaryotic cell bank assays

Standard ICH-compliant
Prokaryotic cell bank assays

  • Sterility testing
  • Mycobacterium
  • Mycoplasma testing
  • Identity testing
  • Retrovirus testing
  • Bovine/Porcine assays
  • Specific virus assays
  • Adventitous agents/ virology testing (adventitous
    virus, in vivo and in vitro assays)
  • Electron microscopy analysis

  • Monoscepsis / Purity test
  • Bacteriophage detection
  • Infectious titer and viability test
  • Identity by sequencing
  • Metabolic mapping
  • Genetic stability test
  • Retention of selectable markers
  • Retention of recombinant construct
  • Copy number determination
  • Restriction map analysis
  • DNA sequence analysis 

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

  • Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
  • All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
  • Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.

Questions? Call us now

+31 (0)71 408 3700