Contract research services - Cell Bank CharacterisationCell Bank Characterisation Services

Cell bank characterization is a comprehensive testing program that confirms the identity, purity, safety, and genetic stability of your production cell substrate (e.g., CHO, HEK293, microbial hosts) at defined bank levels, typically Master Cell Bank (MCB), Working Cell Bank (WCB), and End-of-Production (EOP) cells.  It is required by global regulators to reduce the risk of adventitious agents, misidentification, and product variability in biopharmaceutical manufacturing.

16S rRNA gene sequencing is a widely used molecular method for confirming bacterial identity because the gene contains conserved regions for broad bacterial detection along with variable regions that support taxonomic identification. Full-length 16S rRNA sequencing combined with phylogenetic analysis provides a robust assessment of the organism’s relationship to established reference strains.

We perform culture-based microbial purity testing using multiple media and extended incubation to detect bacterial and fungal contaminants, including organisms that may grow under different culture conditions. We also assess whether antibiotics or other inhibitory agents could mask contamination by suppressing microbial growth.

Bacteriophage testing evaluates the presence or absence of bacterial viruses that can compromise bacterial cell banks, fermentation performance, and manufacturing consistency. Cell-bank testing programs commonly include assessment for lytic, lysogenic, and/or prophage-related risks, particularly for E. coli and other bacterial production hosts.

Yes. Characterization is performed at multiple points in the cell banking lifecycle: parental/pre-MCB material, MCB, WCB, and End-of-Production (EOP) cells.  MCBs typically receive full characterization, while WCBs undergo an abbreviated but compliant set of tests, with additional assessments at the limit of in vitro cell age as required by ICH Q5A(R1)/Q5D.

We generally require frozen vials from your Master Cell Bank (MCB), Working Cell Bank (WCB), or research cell bank, together with relevant strain history, host information, plasmid/construct maps, sequence references, growth conditions, and applicable acceptance criteria. The exact number of vials required depends on the selected test panel, organism, and whether confirmatory or repeat testing may be needed.

Turnaround time depends on the scope of testing. Identity or viability testing may be completed sooner, whereas extended microbial purity testing, bacteriophage detection, subculture-based genetic stability studies, and sequencing require additional time. We recommend defining the complete cell bank characterization plan early so testing can be aligned with your research, manufacturing, or regulatory timeline.