Cell Line Characterization - Creative Biolabs

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.