🔬 Where KROMATID Supports CMC for Cell & Gene Therapies

Bringing Genomic Clarity to Chemistry, Manufacturing, and Controls

As cell and gene therapy programs advance toward the clinic, the expectations for Chemistry, Manufacturing, and Controls (CMC) have never been higher. Regulatory agencies are increasingly focused on the genomic integrity, manufacturing consistency, and risk mitigation strategies that underpin product safety and efficacy.

KROMATID’s single-cell structural analysis technology is uniquely positioned to support these priorities—offering unmatched visibility into chromosomal structure, vector behavior, and cellular genomic stability. Here's how KROMATID supports CMC teams from early process development through IND and BLA submission.

1. 🧬 Genomic Integrity & Structural Variant Assessment

📌 Why It Matters for CMC

Whether you’re working with gene-edited cells, viral vectors, or engineered cell lines, the genomic stability of your product must be established and maintained across the development lifecycle. Regulators expect this data—especially during key milestones like IND filings or process changes.

🔍 KROMATID’s Role

KROMATID delivers single-cell resolution analysis of:

• Translocations
• Inversions
• Random vector integrations
• Complex chromosomal rearrangements

This level of insight enables CMC teams to monitor the structural fidelity of engineered genomes over time, across scale-up, or following changes to manufacturing processes.

2. ⚙️ Manufacturing Consistency & Comparability

📌 Why It Matters for CMC

Even minor changes in manufacturing—like switching vector systems, altering culture conditions, or expanding at scale—can introduce unintended genomic variation or subclonal outgrowth. Traditional CMC assays may miss these rare or cell-specific events.

🔍 KROMATID’s Role

KROMATID complements your existing CMC toolkit by:

• Detecting low-frequency structural variants
• Confirming consistency of product cell populations
• Assessing comparability between manufacturing runs or process improvements

This data helps ensure your therapeutic product remains genomically consistent, stable, and safe—key pillars of CMC compliance.

3. 📁 IND & BLA Support

📌 Why It Matters for CMC

As the FDA and other regulators evolve their expectations, sponsors must go beyond sequencing to provide orthogonal, cell-specific evidence of genomic safety.

🔍 KROMATID’s Role

Data generated from KROMATID’s platform can directly support regulatory submissions by demonstrating:

• Absence of unintended integration events
• Genomic stability across passaging
• Structural safety of editing methods (e.g., CRISPR, lentivirus, AAV)

This is the kind of cell-level genomic clarity regulators now seek—especially when preparing INDs or BLAs for review.

4. ⚠️ Risk Assessment & Safety Strategy

📌 Why It Matters for CMC

Off-target effects, insertional mutagenesis, and structural rearrangements can have profound safety implications—especially when undetected. A strong risk strategy must account for rare but high-impact genomic events.

🔍 KROMATID’s Role

KROMATID enables early, data-driven decisions by:

• Quantifying low-prevalence structural variants
• Identifying subclonal risks within heterogeneous cell populations
• Flagging events that might be missed by bulk sequencing or OGM

By detecting these risks before clinical trials, sponsors can proactively refine product design, manufacturing, and monitoring strategies.

📊 Summary: Why CMC Teams Should Bring KROMATID to the Table

🚀 From Development to Submission—With Genomic Confidence

KROMATID isn’t just a research tool—it’s a CMC enabler. As expectations around genomic safety tighten, the ability to deliver structural variant data at the single-cell level will increasingly define success in cell and gene therapy programs.

If your CMC strategy involves engineered cells, editing technologies, or viral vectors, KROMATID can help you move forward with confidence—one genome at a time.