Bio-Rad, 12016814, Vericheck ddPCR HEK293 Residual DNA Quantification Kit

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.
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 quantitative PCR (qPCR), face challenges due to lack of specificity and reproducibility. The Vericheck ddPCR HEK293 Residual DNA Quantification Kit for ddPCR Assays has been designed to quantify residual HEK293 DNA in biotherapeutics with high specificity and reproducibility without the need for extraction.
Features and Benefits
• High sensitivity and specificity Limit of detection (LOD) of 0.1 pg/µl (3 wells) and limit of quantification (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
• Limit of detection (LOD) of 0.1 pg/µl (3 wells) and limit of quantification (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
• 99.9% specificity to HEK293 DNA when tested against CHO, E. coli , and Vero DNA
• Extraction-free, easy-to-use protocol Broad range of sample types from in-process samples (cell lysates, cell culture media, sonicated samples, and adeno-associated virus [AAV] vectors) to purified final product (phosphate buffered saline [PBS] with human serum albumin)
• Broad range of sample types from in-process samples (cell lysates, cell culture media, sonicated samples, and adeno-associated virus [AAV] vectors) to purified final product (phosphate buffered saline [PBS] with human serum albumin)
• Auto-thresholding with Regulatory Edition software Automated data analysis using in-kit positive control with QX Manager Software version 1.2 / QX ONE Software version 1.2, Regulatory Edition FDA 21 CFR Part 11 compliant, 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, Regulatory Edition
• FDA 21 CFR Part 11 compliant, offering audit trails with tracked protocol changes
Product Contents
• Quant Kit includes: Quantitative Assay ddPCR RDQ Supermix Positive Control Negative Control Internal Control
• Quantitative Assay
• ddPCR RDQ Supermix
• Positive Control
• Negative Control
• Internal 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