Edit Optimization
De-risk editing strategies early to select approaches that scale to the clinic and manufacturing.
Application: Edit Optimization
Early, high-resolution insight into editing outcomes allows teams to make confident decisions before costly downstream commitments.
Key Challenges Addressed
-
True Single-Cell Knock-In EfficiencyUnpredictable insertion rates waste time, reagents, and cells.Teams are working to avoid:
- Endless optimization cycles
- Failed experiments or batches
- Low-yield manufacturing runs
-
Off-Target Editing and Missed Structural ChangesNGS alone may miss large or complex genomic alterations.Teams are working to avoid:
- Undetected structural variants
- Regulatory red flags
- Long-term safety risks
-
Uncontrolled Integration PatternsPrecision matters—teams want controlled location and copy number.Teams are working to avoid:
- Random integrations
- Multi-copy insertions
- Disruption of essential genes
-
Hidden Genomic InstabilityEven “successful” edits can introduce:
- Deletions
- Duplications
- Inversions
- Translocations
- Aneuploidy
Teams are working to avoid:
Cells with latent instability or risky phenotypes. -
Late-Stage IND Failures
Poor genetic control often surfaces too late.Teams are working to avoid:- Failed genotoxicity
- Requests for additional genomic characterizations
- Delayed commercialization
-
Manufacturing That Doesn’t ScaleBench-scale success doesn’t guarantee commercial success.Teams are working to avoid:
- Shifts in editing performance at scale
- Process-induced genomic artifacts
- Batch-to-batch inconsistency
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.

Peer Science
The Next Evolution of Cytogenetics: From Observation to Action
For decades, cytogenetics has played a critical role in therapy development. It has helped us see when genomes are altered, unstable, or outright broken. But as cell and gene therapies become more sophisticated - and the margin for error shrinks - seeing is no longer enough.
Feb 17, 2026
All HSCs Are Not Created Equal: The Importance of Testing Your Starting Material
Hematopoietic stem cells (HSCs) sit at the foundation of many cell and gene therapy programs. Whether used in autologous or allogeneic settings, ex vivo gene editing or viral transduction, HSCs are often treated as a standardized input—assumed to be equivalent as long as basic identity, viability, and purity criteria are met.
Feb 2, 2026
2025: A Pivotal Year for Genomic Insight - and What Comes Next in 2026
Despite numerous challenges, the cell and gene therapy (CGT) sector has never moved faster. In 2025, we saw breakthroughs in precision editing, rapid scale-up of manufacturing platforms, and renewed investor attention on therapies with clear clinical differentiation. But alongside the scientific momentum, one theme stood out more than any other: genomic stability is now a defining hallmark for safety, reproducibility, and regulatory confidence.
Dec 15, 2025
