Vericheck ddPCR HEK293 Residual DNA Quantification Kit

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Vericheck HEK293

Overview

The Vericheck ddPCR HEK293 Residual DNA Quantification Kit, with a novel ddPCR assay, has been designed to quantify residual HEK293 DNA in biotherapeutics with high specificity and reproducibility, without the need for reference curves.

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Description

Description

Biotherapeutic products are manufactured in immortalized cell lines, most commonly HEK293. Residual DNA from HEK293 lines can harbor tumorigenic genetic sequences or retroviral sequences that could be transmitted through the biotherapeutic to the human recipients. Accurate quantification of HEK293 DNA is essential to produce a safe and appropriate therapeutic dose. However, the standard methods used for such quantification, like qPCR, face challenges due to lack of specificity and reproducibility. The Vericheck ddPCR HEK293 Residual DNA Quantification Kit, with a novel 5-plex ddPCR assay, has been designed to quantify residual HEK293 DNA in biotherapeutics with high specificity and reproducibility, without the need for reference curves.

The Vericheck ddPCR HEK293 Residual DNA Detection Kit provides:

  • High Sensitivity and Specificity
    • LOD of 0.1 pg/µl (3 wells) and LOQ of 1 pg/µl (3 wells)
    • Low cross-reactivity and low false-positive rate
      • 99.9% specificity to HEK293 DNA when tested against CHO, E. coli, and Vero DNA
  • Extraction-free, easy-to-use protocol
    • The assay works with broad range of sample types from in-process samples (cell lysate, cell culture media, sonicated sample, AAV) to purified final product (PBS with human serum albumin) using an extraction-free workflow
  • Auto-thresholding with Regulatory Edition software
    • Automated data analysis using in-kit positive control
    • QX Manager Software / QX ONE Software Regulatory Edition, offering tools and audit trails with tracked protocol changes to help with US FDA 21 CFR Part 11 compliance

Applications and Uses

  • Quantitative data analysis providing confirmation on the quantity of HEK293 residual DNA

Configuration Options (or Instrument Compatibility)

(Bundles or different component sets) Catalog Number
QXONE Droplet Digital PCR System 12006536
QX200 AutoDG Droplet Digital PCR System consisting of:
QX200 Droplet Reader
Automated Droplet Generator
1864100
1864003
1864101
QX Manager Software, Regulatory Edition 12012172
QX Manager Software, Standard Edition 12012171
QX ONE Software, Regulatory Edition 12012078

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The Vericheck ddPCR HEK293 Residual DNA Quantification Kit brings the specificity in testing for HEK293 DNA contamination. The precision and reproducibility of this kit allows for an absolute measurement of residual HEK293 DNA using Droplet Digital PCR.

Kits & Reagents

Kits & Reagents

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1814040
Pkg of 100, foil seals for PCR and QX200/QX100 Droplet Digital PCR System applications, for use with PX1 PCR Plate Sealer
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12001925

Pkg of 25, clear well/clear shell semi-skirted plates, for use with QX200™/QX100™ or QX200™ AutoDG™ Droplet Digital™ PCR Systems

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1864108
Pkg of 30, cartridges for use with the Automated Droplet Generator in the QX200 AutoDG Droplet Digital PCR System
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dg32-automated-droplet-generator-cartridges-186-4009-thumb.jpg
1864109
Pkg of 60, cartridges for use with the Automated Droplet Generator in the QX200™ AutoDG™ Droplet Digital™ PCR System
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pipet-tips-for-the-autodg-system-186-4120-thumb.jpg
1864120
Pkg of 20, boxes of 96 each, pipet tips for use with the Automated Droplet Generator in the QX200™ AutoDG™ Droplet Digital™ PCR System
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pipet-tips-for-the-autodg-system-186-4121-thumb.jpg
1864121
Pkg of 40, boxes of 96 each, pipet tips for use with the Automated Droplet Generator in the QX200™ AutoDG™ Droplet Digital™ PCR System
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pipet-waste-bins-for-the-auto-dg-system-186-4125-thumb.jpg
1864125
Pkg of 10, pipet tip waste bins for use with the Automated Droplet Generator in the QX200™ AutoDG™ Droplet Digital™ PCR System
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automated-droplet-generation-oil-for-probes-186-4110-thumb.jpg
1864110
140 ml, oil for use with the Automated Droplet Generator for probe-based detection with the QX200 AutoDG Droplet Digital PCR System

Documents

Documents

Number Description Options
3304
Vericheck ddPCR HEK293 Resdual DNA Quant Kit Flyer
[ Add to Cart (Free) ]
10000146103
Vericheck ddPCR HEK293 Residual DNA Quant Kit, User Guide
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3314
Transitioning from Quantitative PCR to Droplet Digital PCR for HEK293 Quantitative Detection
[ Add to Cart (Free) ]