Vericheck ddPCR HEK293 Residual DNA Size Kit

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Vericheck ddPCR HEK293 Residual DNA Sizing Kit

Overview

A HEK293 specific ddPCR based sizing solution, designed, and validated to meet regulatory guidance requirements and capable of measuring HEK293 size without the use of reference curves.

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Description

Description

Human gene therapy products are produced in immortalized cell lines, most commonly HEK293. Residual DNA from immortalized cell lines can harbor tumorigenic genetic sequences or retroviral sequences that can cause infection. The FDA recommends that manufacturers degrade any residual DNA to a size below that of a functional gene, defined as <200 base pairs. Manufacturers require an inexpensive, accurate, and reliable way of measuring the size of residual DNA, which ddPCR technology can provide.

The Vericheck ddPCR HEK293 Sizing Kit is the first HEK293 specific ddPCR based sizing solution that has been designed, and validated to meet regulatory guidance requirements and capable of measuring HEK293 size without the use of reference curves.

Features and Benefits

  • High Specificity and Sensitivity
    • Low cross reactivity and low false-positive rate;
      • 95% specificity to HEK293 DNA when tested against CHO, E. coli, and Vero DNA
    • Limit of Blank (LOB) of 0 with Limit of Detection (LOD) of 2 pg/well
  • Extraction-free protocol without use of standard curves
    • 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 Compliant Software
    • Provides median size of residual DNA fragments with confidence intervals
  • Positive control-based auto-thresholding with regulatory compliant software
    • Automated data analysis using in-kit positive control with QX Manager Software version 1.2 / QX ONE Software version 1.2
    • 21 CFR Part 11 compatible offering audit trails with tracked protocol changes

Applications and Uses

  • Quantitative data analysis providing confirmation on the size of HEK293 residual DNA
(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
Software  
QX Manager Software, Regulatory Edition 12012172
QX Manager Software, Standard Edition 12012171
QX ONE Software, Regulatory Edition 12012078

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Vericheck ddPCR HEK293 Residual DNA Sizing Kit
12016813

The Vericheck ddPCR HEK293 sizing kit is the first HEK293 specific ddPCR based sizing solution, designed, and validated to meet regulatory guidance requirements and capable of measuring HEK293 size without the use of reference curves.

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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droplet-digital-pcr-plate-stack-12001925-thumb.jpg
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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dg32-automated-droplet-generator-cartridges-186-4008-thumb.jpg
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

Download

Download

Determine residual DNA size with confidence using the Vericheck ddPCR HEK293 Res DNA Sizing Worksheet
HEK29-Residual-DNA-Sizing-Worksheet_v1.0

Determine residual DNA size with confidence using the Vericheck ddPCR HEK293 Res DNA Sizing Worksheet

Documents

Documents

Number Description Options
3305
Vericheck ddPCR HEK293 Resdual DNA Sizing Kit Flyer
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10000146104
Vericheck ddPCR HEK293 Residual DNA Sizing Kit, User Guide
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