Overview
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.
Safety Data Sheet
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, 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
Features and Benefits
- Quant Kit includes:
- Sizing Assay
- ddPCR RDQ Supermix
- Positive Control
- Negative Control
Configuration Options
| (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 |
Related Products
Supporting Documents
- Flyer- In works
- User guides- In works