What characterization tests are performed on cell banks?

Cell bank characterization ensures safety, identity, and suitability for production. Tests include: Identity testing (species confirmation by karyology, isoenzyme analysis, DNA fingerprinting, or sequencing), genetic characterization (insert verification, copy number, integration site), purity testing (sterility, mycoplasma, adventitious viruses, bacteriophage for bacteria), viability assessment (post-thaw recovery, growth characteristics), phenotype verification (productivity, stability testing), and species-specific tests (e.g., retrovirus testing for rodent cells). Regulatory guidelines (ICH Q5A, Q5B, Q5D) specify required tests. Extended characterization may include: whole-genome sequencing, transcriptomics profiling, and metabolic characterization. Documentation forms part of regulatory submissions.