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Product Details
Product Overview
The HEK293 resDNA Quantitation Kit is intended for the quantitative determination of residual HEK293 host cell DNA in biopharmaceutical manufacturing processes, including recombinant antibodies, viral vectors, cell therapies, CAR-T products, gene therapies, and related biological products. Utilizing a real-time quantitative PCR (qPCR) platform, this kit enables sensitive, rapid, and reliable quantification of residual HEK293 genomic DNA with a lower limit of quantitation (LLOQ) of 3 fg/µL. This kit is used following host cell DNA extraction from test samples. To achieve optimal DNA recovery and purification efficiency, it is strongly recommended to be used in conjunction with the HEK293 / HEK293T resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R033).
Features
- Ultra-high sensitivity for optimal product safety: Stable detection of HEK293 host cell residual DNA down to 3 fg/μL
- Traceability: Traceable to USP HEK293 DNA reference standard (USP Catalog number : 1592106)
- High specificity: No cross-reactivity with unrelated DNA
- Regulatory compliance: ICH Q2(R2) & FDA Bioanalytical Method Validation compliant
- Premium quality: Manufactured in ISO 13485 certified facility
Application
The kit is used for quantitative detection of residual Human DNA in biopharmaceuticals.
For use in quality control/manufacturing process only.
It is for research use only.
Technical Specifications
Attention
If your experimental workflow involves host cell DNA sample preparation, please use the recommended sample preparation kits listed in the table. This ensures that the buffers used during both sample preparation and residual DNA quantitation remain consistent, supporting reliable and accurate results.
Materials Provided
IDComponentsSizeOPA-R031-012×qPCR Master Mix1.0 mL×2OPA-R031-02HEK293 Primer & Probe Mix700 μLOPA-R031-03HEK293 DNA Control（3ng/μL）100 μLOPA-R031-04Dilution Buffer1.5 mL×3OPA-R031-05DNase/RNase-Free Water1.0 mLACRO Quality Management System
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Performance Data
Typical Data
Please refer to DS document for the assay protocol.
Figure 1. High sensitivity and broad dynamic range of the HEK293 resDNA Ultra-Low Quantitation Kit. (A) Representative analysis results for Standards 1 (300 pg/μL) through 6 (3 fg/μL). (B) Standard curve generated from the 10-fold serial dilution series. The expected PCR efficiency is 90-110%.
Figure 2. Assay specificity. Standard curves were generated using a 10-fold serial dilution of HEK293 genomic DNA (included in the kit) in the presence of CHO, E. coli, and Pichia pastoris DNA.
HEK293 genomic DNA was fragmented by enzymatic digestion for 10, 20, and 30 minutes, generating DNA of varying fragment sizes. Each fragmented DNA sample was subjected to 10-fold serial dilution and quantified using qPCR. The resulting standard curves for all fragment sizes met acceptance criteria, indicating that DNA fragmentation has no significant impact on the assay performance.
Figure 3. Standard Curves for HEK293 DNA with Different Fragmentation Levels.
HEK293 genomic DNA was fragmented by enzymatic digestion for 10, 20, and 30 minutes, generating DNA of varying fragment sizes. Each fragmented DNA sample was subjected to 10-fold serial dilution and quantified using qPCR. The resulting standard curves for all fragment sizes met acceptance criteria, indicating that DNA fragmentation has no significant impact on the assay performance.
Figure 4. Three different lots of the resDetect™ kit were used to extract and quantify HEK293 DNA from samples with two different spiking levels. The acceptance criterion for recovery was 50–150%. The recovery rates for the three different reagent lots ranged from 84.32% to 96.98%, demonstrating consistent performance across different lots.
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