Cell Line Characterization
Genetic stability and transgene integrity are essential quality attributes of engineered cell lines and genetically modified cell systems. Over extended periods of culture, expansion, or genetic manipulation, cells can undergo chromosomal rearrangements, copy number alterations, insertional events, or transcriptional changes that may directly affect product consistency, safety, and functional performance.
The Cell Line Characterization services offer a range of solutions to provide multi-level characterization of engineered genomes. Through a combination of cytogenetic, molecular, and sequencing-based approaches, our assays can help you to monitor the genetic integrity, map transgene insertion sites with precision, evaluate clonal structure, and detect rare instability events, and empower your cell line development and downstream translational research.
Featured Services
Stable Cell Line Genetic Stability Testing
Longitudinal assessment of chromosomal integrity and transgene stability to ensure consistency across passages and production timelines.
Genetic Stability Testing (Locus Amplification + ddPCR)
Combine fluorescence in situ hybridization (FISH) with droplet digital PCR (ddPCR) to detect copy number variations (CNVs) and monitor transgene amplification or loss.
Precisely localize transgene integration sites within host genomes using FISH-based cytogenetic mapping, providing visual confirmation of chromosomal integration.
Transgene Mapping (Locus Amplification & Sequencing)
Combine PCR-based locus amplification with next-generation sequencing (NGS) to identify exact integration sites and flanking genomic sequences.
Clonality Analysis Service (FISH)
Verify monoclonality in engineered cell lines using FISH-based single-cell analysis, a critical requirement for regulatory submissions.
Key Analytical Capabilities
- High-resolution transgene mapping: Identify integration sites with single-nucleotide precision.
- Copy number quantification: Accurately measure transgene dosage using ddPCR and FISH.
- Long-term genetic stability assessment: Monitor genomic integrity across multiple passages.
- Splice variant detection: Confirm proper mRNA processing and detect aberrant splicing.
- Regulatory-compliant clonality proof: Provide definitive evidence of monoclonality for FDA/EMA filings
Why Choose Our Cell Line Characterization Services
Tailored strategies for specific cell types, transgene constructs, and study goals.
Application-Driven Assay Design
Combining cytogenetic, molecular, and sequencing approaches for a more comprehensive insight.
Integrated Multi-Modal Analysis
Detection of low-frequency events and subtle genomic changes.
High Sensitivity and Resolution
Standardized workflows and rigorous quality controls for reliable results.
Reproducible and Robust Data
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