Overview
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
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
700 ml, droplet reader oil for use with the QX ONE ddPCR System
