Vericheck ddPCR HEK293 Residual DNA Quantification Kit by Bio-Rad

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