Custom HCD Kit Development

Service.

Custom-designed qPCR kits

For customers using proprietary yeast, fungal, or bacterial hosts,
conventional universal HCD (Host Cell DNA) assays may show limited detectability or issues with specificity and sensitivity.
CellSafe provides custom-designed qPCR kits optimized for each client’s unique strain.
Service Items
- Custom primer and probe design based on the client’s strain sequence (or provided gDNA)
- 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, Simultaneous detection of multiple proprietary hosts
- Sample Pretreatment & DNA Extraction Kits: Optimized pretreatment procedures tailored to each sample type
Applicable Customers
- Clostridium botulinum - based products
- Cell-based vaccines - proprietary MDCK, Vero, etc
- Viral vector production cell lines
- Companies with engineered cell lines or microbial strains
- Live Biotherapeutic Products (LBP) developers
Service Workflow
1. Discussion
2. NDA
  /Contract Signing
3. Primer Design
4. Performance
  Test
5. Prototype
  Testing
6. Reference
  Material Production
7. Validation
  & Documentation
8. Application
  Complete
Turnaround Time
- Average: 4 months (varies by service items)