Bio-Rad, 12016813, Vericheck ddPCR HEK293 Residual DNA Size Kit

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.
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, 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 95% specificity to HEK293 DNA when tested against CHO, E. coli , and Vero DNA
• 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
• 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
• 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
• 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
• Sizing Assay
• ddPCR RDQ Supermix
• Positive Control
• Negative Control
Configuration Options
Related Products
• Vericheck ddPCR Mycoplasma Detection Kit
• QX ONE Droplet Digital PCR System
Supporting Documents
• Flyer- In works
• User guides- In works