CHO Residual DNA Detection Kit (qPCR), BP-QN88, quantitatively detects residual CHO host-cell DNA in bioprocess samples using probe-based qPCR with calibrators and an internal control.
CHO Residual DNA Detection Kit (qPCR), BP-QN88
Product information published by Zhuhai Biori Biotechnology Co., Ltd.
Features
- Probe-based qPCR assay targeting conserved CHO cell sequences.
- Six calibrators from 3 fg/µL to 300 pg/µL support quantitative analysis.
- Exogenous internal standard monitors extraction and amplification performance.
- UDG enzyme helps prevent amplification-product carryover contamination.
- 100 reactions per kit.
Application
- Quantification of residual CHO host-cell DNA in biopharmaceutical process samples.
- Testing of intermediates, semi-finished products, and finished products.
- Process development and release-support workflows using compatible real-time PCR instruments.
Components
| Component | Specification |
|---|---|
| CHO qPCR MIX | 1.0 mL × 2 tubes |
| CHO Internal Standard | 1.0 mL × 1 tube |
| CHO Negative Control | 1.0 mL × 2 tubes |
| CHO Calibrator ST1 | 0.5 mL × 1 tube; 3 fg/µL |
| CHO Calibrator ST2 | 0.5 mL × 1 tube; 30 fg/µL |
| CHO Calibrator ST3 | 0.5 mL × 1 tube; 300 fg/µL |
| CHO Calibrator ST4 | 0.5 mL × 1 tube; 3 pg/µL |
| CHO Calibrator ST5 | 0.5 mL × 1 tube; 30 pg/µL |
| CHO Calibrator ST6 | 0.5 mL × 1 tube; 300 pg/µL |
Shipping and Storage
| Condition | Recommendation |
|---|---|
| Shipping Temperature | Ship frozen on dry ice or with validated frozen cold-chain packaging. |
| Storage Temperature | ≤ -20°C, protected from light. |
| Shelf Life | 24 months. Avoid more than 10 freeze-thaw cycles. |
Data
Performance Data
CHO Residual DNA Detection Kit (qPCR) | Catalog No. BP-QN88-100
A product-specific validation study evaluated analytical measurement performance for CHO residual DNA. This selected upload version includes only the supported linearity, quantitation, detection, and recovery results.
Key Performance at a Glance
| Perf |
Sele |
|---|---|
| Line |
0.5 fg/ |
| Limi |
0.5 fg/ |
| Limi |
0.125 fg/ |
| Reco |
70%- |
Analytical Measurement Performance
Observed in this validation study: across the evaluated linear range of 0.5 fg/μL to 300 pg/μL, the correlation coefficient was 0.9999 and amplification efficiency was 98.69%. At 0.125 fg/μL, 30 of 30 replicates were detected.
Recovery
Recovery was evaluated at four spike levels. Observed in this validation study: recovery values in the selected table ranged from 92.69% to 112.68%.
| Spik |
Repl |
Repl |
Repl |
Mean | Reco |
|---|---|---|---|---|---|
| 3.00 |
2.93 |
2.49 |
2.92 |
2.78 |
92.69% |
| 3.00 |
3.10 |
2.90 |
2.93 |
2.98 |
99.21% |
| 3.00 |
2.83 |
3.13 |
2.61 |
2.86 |
95.17% |
| 3.00 |
3.43 |
3.64 |
3.07 |
3.38 |
112.68% |
Study Scope and Limitations
Results apply to the reference materials, instruments, and study conditions used in this product-specific validation study. The inconsistent source figure is not included and is not used as specificity evidence. Users should verify suitability with their own sample matrix and workflow.
