Overview
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
- Low cross reactivity and low false-positive rate;
- 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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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
Pkg of 100, foil seals for PCR and QX200/QX100 Droplet Digital PCR System applications, for use with PX1 PCR Plate Sealer
Pkg of 25, clear well/clear shell semi-skirted plates, for use with QX600/QX200 Droplet Digital™ PCR Systems
Pkg of 30, cartridges for use with the Automated Droplet Generator in the QX600/QX200 AutoDG Droplet Digital PCR System
Pkg of 60, cartridges for use with the Automated Droplet Generator in the QX600/QX200 AutoDG™ Droplet Digital™ PCR System
Pkg of 24, cartridges for use with the QX200 Droplet Generator
5 pkg of 24 DG8 Cartridges, 5 pkg of 24 DG8 Gaskets, for use with the QX200 Droplet Generator
Pkg of 24, gaskets for use with QX200 Droplet Generator
5 pkg of 24 DG8 Cartridges, 5 pkg of 24 DG8 Gaskets, for use with the QX200 Droplet Generator
70 ml (10 x 7 ml), oil for use with droplet generator in the QX600/QX200 Droplet Digital™ PCR Systems
2 L (2 x 1 L), oil for use with droplet reader in the QX600/QX200 Droplet Digital™ PCR Systems
Pack of 10 cartridges for use with the QX ONE ddPCR System
700 ml, droplet reader oil for use with the QX ONE ddPCR System
Downloads
Determine residual DNA size with confidence using the Vericheck ddPCR HEK293 Res DNA Sizing Worksheet