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Viral vectors (such as lentivirus LV and adeno-associated virus AAV) are core tools for gene therapy, enabling long-term stable expression of exogenous genes through genomic integration. However, random integration may pose insertional mutagenesis risks, including oncogene activation (such as LMO2, CCND2), tumor suppressor inactivation, or abnormal transcript generation. According to the IQVIA 2024 industry report, among 76 approved cell and gene therapy products globally, 23% were terminated during clinical trials due to safety concerns, with integration-related risks accounting for over 60%.
Creative Biogene specializes in full-spectrum services for gene therapy, cell therapy and gene editing technologies, providing solutions from early research to commercial production for global biopharmaceutical companies, research institutions, and clinical units. Leveraging 15 years of viral vector development experience, Creative Biogene offers comprehensive integration site detection services to help clients optimize vector design, reduce clinical risks, and accelerate drug marketing.
Creative Biogene utilizes advanced LAM-PCR technology and innovative multiplex analysis strategies to deliver high-throughput, high-resolution results, helping clients meet FDA and NMPA regulatory requirements for gene therapy products. We offer three analytical approaches—LAM-PCR, EPTS LM-PCR, and Hybridization-Based Enrichment Sequencing (HES)—to support integration site analysis, vector integrity assessment, and more.
Technical Principle: Based on restriction enzyme digestion and dual barcode strategy, combined with next-generation sequencing for precise host genome integration site location
Key Parameters:
Sensitivity: Capable of detecting low-frequency integration events
Throughput: 10,000+ integration sites analysis per experiment
Limitations: Enzyme cutting preference, semi-quantitative analysis (clone abundance error ±15%)
Suitable Applications: Preliminary screening of integration hotspots, monitoring clonal expansion trends in CAR-T therapy
Figure 1. LAM-PCR Workflow.
Technical Breakthrough: Optimized primer design and non-restrictive amplification strategies, reducing sequence preference interference
Core Advantages:
Precise quantification: Clone contribution measurement error<5%, supports longitudinal dynamic tracking
Low sample requirements: DNA starting amounts ≥50 ng (compatible with biopsy samples)
Typical Applications: Long-term safety tracking of AAV vectors, clone stability assessment in stem cell therapy
Figure 2. EPTS LM-PCR Workflow.
Technical Principle: Based on complementary pairing between DNA molecules, using specific probes to bind and enrich target sequences
Technical Highlights: Targeted probe capture combined with long-read sequencing for simultaneous analysis of integration sites and vector copy number variations
Core Value:
Single-base resolution: Precise identification of low-frequency AAV vector integration
Whole-genome annotation: Functional correlation analysis between integration sites and adjacent genes
Recommended Uses: IND/NDA filing data package preparation, high-sensitivity biosafety verification
Figure 3. HES Workflow.
Multi-dimensional Technical Coverage
Full-cycle Compliance Support
Flexible Service Models
Creative Biogene provides suitable solutions for different sample types:
| Service Level | Research Grade | Clinical Grade |
| Sample Volume | 1-10 samples | 10-100 samples |
| Deliverables | Basic IS distribution map | Whole-genome annotation + clone dynamic tracking |
| Timeline | 4-6 weeks | 8-12 weeks |
Navigating the complex regulatory landscape of gene therapy development requires both technical expertise and regulatory insight. Our scientific team is ready to evaluate your specific project needs and design a tailored integration site analysis strategy that balances sensitivity, throughput, and compliance requirements. Whether you're in early discovery or preparing for IND submission, our consultants can help identify the most efficient approach for your timeline and budget constraints. Contact us today to discuss how our IS detection services can accelerate your path to market while ensuring the highest safety standards.
Q: How do I choose the right detection technology for my needs?
A:
1. Quick screening → LAM-PCR (4-week delivery, lowest cost)
2. Trace samples/dynamic tracking → EPTS LM-PCR (error<5%)
3. IND filing/ultra-high sensitivity → HES (copy number analysis)
4. Technical consultants provide customized solutions within 24 hours
Q: What are the specific requirements for sample submission?
A: Sample types: Genomic DNA (≥50 ng/μL) or cell samples (≥1×106 cells)
Transport conditions: Dry ice (-80°C) or DNA stabilizing solution (4°C, 72-hour delivery)
Special handling: Infectious samples require inactivation and biosafety labeling
Q: What are the standards and formats for data delivery?
A: Basic reports include integration site BED files (hg38/mm10), clone abundance tables, and risk heat maps; advanced analysis provides adjacent gene annotations (COSMIC/ClinVar databases) and clone evolution tree visualization; original data including FASTQ and BAM files are also provided (downloadable via encrypted cloud storage).
Q: How are data confidentiality and intellectual property protected?
A: We ensure legal protection through NDA confidentiality agreements and independent server storage (compliant with GDPR/CCPA); physical isolation is achieved through client-exclusive experimental areas to prevent cross-contamination; data is transmitted only through encrypted channels with delivery control supporting third-party audits.
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