The ResHCDTM Residual Host Cell DNA Quantitation Kit series provides a comprehensive and reliable solution for monitoring residual host cell DNA levels in biopharmaceutical products and drug substance samples derived from the engineered production cell lines.
The ResHCDTM Pichia Pastoris DNA Quantitation Kit is specifically designed for highly sensitive quantitation of residual Pichia Pastoris genomic DNA. By integrating optimized primer design with advanced qPCR reagent chemistry, this kit enables rapid, highly specific, and reliable detection of trace levels of residual Pichia Pastoris DNA with femtogram-level sensitivity.
The product described herein is for Research Use Only and is not intended for diagnostic or therapeutic use.
| Components | Shipping Condition | Unit Size | Detection Method |
| qPCR Reaction MIX-1 | -20℃, protect from light | 100 Reactions | Probe-based qPCR |
| Pichia Pastoris Primer&Probe MIX | |||
| IPC MIX-3 | |||
| DNA Dilution Buffer (DDB) | -20℃ | ||
| Pichia Pastoris DNA Control |
Wide Dynamic Range for Accurate Quantitation
High-quality DNA standards enable robust standard curve generation with excellent linearity across a broad dynamic range of 0.01 pg/μL to 300 pg/μL, supporting accurate quantitation of residual Pichia Pastoris DNA from complex process intermediates to highly purified final biopharmaceutical products.
Superior Specificity for Pichia Pastoris Genomic DNA
Optimized primer design provides exceptional specificity toward Pichia Pastoris genomic DNA with no detectable cross-reactivity, ensuring reliable and accurate residual DNA quantitation across diverse sample matrices.
Streamlined Workflow with High Reproducibility
A simplified workflow integrating sample preparation, qPCR amplification, and data analysis enables rapid, consistent, and reproducible results. When combined with the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Fast), the system delivers efficient DNA recovery and reliable quantitation even from complex biological matrices.
Enhanced Stability for Global Distribution
Optimized enzyme formulations and proprietary stabilizing components enhance reagent robustness against temperature fluctuations, enabling reliable transportation and extended storage stability. The assay maintains consistent performance after storage at 2–8°C for up to two months, with no significant impact on assay performance observed.
| Linearity and range | 1.00x10-2 to 3.00x102 pg/μL, R2=0.99886, E=98.1% |
| Accuracy | Recovery range: 93.8% to 107.0%, CV values < 20% |
| Quantitation limit (QL) | 0.00943 pg/μL |
| Detection limit (DL) | 0.001 pg/μL |
| Precision | CV values: 3.8% to 17.9% |
| Specificity | No detectable cross-reactivity between CHO, E. Coli, Vero cell |
| Repeatability | Sample with three concentration level, CV values: 4.5% to 23.2% |
| Robustness | Instrument suitability not limited to Thermo, Biorad, SHENTEK qPCR equipments |
| Freeze-thaw stability over 5 cycles |
SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Fast)
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