CellSafe

Service.

Custom RCV Kit Development

Custom RCV Kit Development

  1. Custom RCV Kit Development

    For quality control and long-term monitoring of gene therapy products using viral vectors, detection of replication-competent viruses (RCV) is essential.
    CellSafe develops custom detection and quantification kits tailored to the specific viral vector sequences of each client.

  2. Service Items

    • Custom primer and probe design based on the client’s vector sequence
    • Comprehensive Validation Package: LOD, LOQ, Recovery, linearity, specificity, and matrix effect verification
    • Regulatory Submission Package: Validation protocol & report compliant with ICH Q2 guidelines
    • Multiplex Options: Cross-contamination check using the positive control
    • Sample Pretreatment & DNA Extraction Kits: Optimized pretreatment procedures tailored to each sample type

  3. Performance Improvement

    Before improvement example image
    Custom RCV Kit Performance Improvement Example: Before Improvement Image
    After improvement example image
    ustom RCV Kit Performance Improvement Example: After Improvement Image

  4. Service Workflow

    1. Commercialized Kit
      Testing
    2. NDA
      /Contract Signing
    3. Primer Design
    4. Performance
      Test
    5. Prototype
      Testing
    6. Reference
      Material Production
    7. Validation
      & Documentation
    8. Application
      Complete

  5. Turnaround Time

    • Average: 4 months (varies by service items)

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