resDetect™ HEK293 resDNA Ultra-Low Quantitation Kit (qPCR)

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OPA-R031-100tests
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OPA-R031
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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
DNA 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.

DNA Attention
Materials Provided
ID
Components
Size
OPA-R031-01
2×qPCR Master Mix
1.0 mL×2
OPA-R031-02
HEK293 Primer & Probe Mix
700 μL
OPA-R031-03
HEK293 DNA Control(3ng/μL)
100 μL
OPA-R031-04
Dilution Buffer
1.5 mL×3
OPA-R031-05
DNase/RNase-Free Water
1.0 mL