Cell Line Characterization

Cell Bank

Cell line characterization is a key step in ensuring the safety of biopharmaceutical products with the aim of confirming the identity, purity, genetic stability and tumorigenicity of cell lines. This characterization can ensure that the source of the cell line is authentic and free from contamination, undesirable cells and foreign factors such as bacteria, fungi, mycoplasmas, mycobacteria and viruses. International regulatory guidelines such as ICH (Q5A, Q5B, Q5D), EP and USP for cell lines characterization mainly focus on three areas:

1. Source history and generation of cell lines
2. Establish characteristics and tests of cell line identity, purity and genetic stability
3. The banking procedures of the cell line

Creative Biolabs has extensive experience in the cell bank characterization for biopharmaceutical and vaccine production. We offer a wide range of services to characterize cell banks, develop and design scientifically-validated and proven cell line characterization testing methods.

Cell Line Scope

According to document ICH Q5D ‘Quality of Biological Products: Derivatives and Characterization of Cellular Substrates for the Production of Biotechnology/Biological Products’, Creative Biolabs performs cell bank characterization on the following cell lines:

  • Master Cell Banks (MCB)
  • Working Cell Banks (WCB)
  • End-of-Production Cells (EOPC)
  • Virus Seed Stock (VSS)

Cell Line Characterization Tests Available

Eukaryotic Cell Line Characterization

  • Identity Testing
  • RAPD Assays (Random amplified polymorphic DNA)
  • Electron Microscopy Analysis
  • Sterility Testing
  • Mycoplasma Testing
  • Virus Specific Assays
  • In Vivo Virology Assays
  • In Vitro Virology Assays
  • Retrovirus Testing
  • Mycobacterium Assays
  • Nucleic Acid Sequencing Services
  • Genetic Stability Assays
  • Bovine/Porcine Assays
  • Tumorgenicity
  • Oncogenicity

Prokaryotic Cell Line Characterization

  • Gram Stain
  • Culture
  • RAPD Assay
  • Antibiotic Resistance Test
  • Plasmid Sequencing
  • Purity Test
  • Infectious Titer and Viability Test
  • Genetic Stability Test
  • Retention of Recombinant Construct
  • Copy Number Determination
  • Restriction Map Analysis
  • API 20
  • Bacteriophage Test
  • DNA Sequence Analysis
  • Metabolic Mapping

Moving Your Therapeutic Candidates Forward

  • Maintenance of a single master cell line
  • Working cell banks with low passage numbers
  • Identity confirmation by DNA Fingerprinting
  • Purity testing including Mycoplasma, virus, and fungi detection

Eukaryotic and prokaryotic cell banks represent a huge potential value throughout the life of the product. With years of experience and a GMP-qualified laboratory, Creative Biolabs’ cell bank characterization ensures that your biological production process complies with international guidelines.

For more details, please feel free to contact us for project quotations and more detailed information.

For Research Use Only | Not For Clinical Use

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