Genotoxicity profiling provides confidence that edit strategies or cell manipulations are optimized and that manufacturing processes do not introduce genomic changes that could compromise regulatory success or patient safety.
Why it Matters
Detecting Unintentional DNA Damage
Ensure therapies do not introduce:
Harmful mutations
Chromosomal breaks
Large-scale rearrangements
Identifying Off-Target Editing Effects
For CRISPR/Cas, TALENs, viral vectors, transposons, and other platforms, teams need visibility into:
Unexpected insertions or deletions
Variable copy number
Structural variants
Chromosomal abnormalities
Meeting IND/CTA Regulatory Expectations
FDA and EMA expect clear evidence that potential genotoxic effects are understood and controlled—especially for:
Cell and gene therapy programs
Viral vector-based approaches
Confirming Vector Integration Safety
For lentivirus, retrovirus, and even non-integrating systems like AAV, teams must demonstrate:
Integration patterns are non-disruptive
No proximity to oncogenic regions
No large-scale genomic instability
Long-Term Genome Stability in Manufactured Cells
Critical for programs involving:
Engineered cell lines
iPSC-derived cells
CAR-T and TCR therapies
Teams need confidence that expansion, editing, freezing, and downstream processing have not introduced instability.
De-Risking Cancer Formation
Especially important for stem-cell–derived therapies, where early detection of structural abnormalities reduces downstream risk.
Understanding Manufacturing Performance
When cells show poor growth, viability, or drift, genotoxicity profiling reveals:
Structural variants
Integration-related disruptions
Chromosomal abnormalities
Comparing Engineering Approaches
Directly compare genomic outcomes across:
CRISPR vs. base editing
Lentiviral vs. transposon delivery
Applicable KROMASURE™ Solutions:
GLP and GMP Services
From Research to Batch Release Testing
KROMATID’s GLP & GMP Services support your pipeline from the research phase, through IND filing, to batch release testing.
