Introduction

Hzymes Biotech has upgraded its host residual DNA detection products, covering multiple cell types such as CHO, E. coli, Vero, HEK293, Pichia pastoris, and mycoplasma. The primer and probe sequences of the kit are from the pharmacopoeia, so you don’t need to do a full set of validation experiments, just need to confirm the method. Developed based on a quantitative PCR method, LODs can reach 0.003 pg/μL with no cross-reactivity with other DNA, reducing false positives in the assay reaction. Strict production management system, batch-to-batch difference controllable CV<10%. Provide a complete set of solutions for manual extraction and automatic instrument extraction</b40>, which can quickly complete the detection within 2 hours and ensure the accuracy of quantitative detection.

Performance

Sensitive and Accurate

Capable of detecting plasmid DNA residues with high sensitivity and accuracy.

High Specificity

Primers are designed specifically for the kanamycin resistance gene, ensuring strong specificity.

Good Linearity

Offers a wide linear range and excellent linearity in standard samples.

Reliable Results

High accuracy and precision with stable sample recovery rates.

Wide Applicability

Suitable for various domestic and imported quantitative PCR instruments.

Stable Performance

Meets stability test standards, with the ability to be stored for extended periods.

Professional Methodology

Based on testing standards and methods established by domestic and international regulatory agencies, ensuring authority.

Standard Amplification Curve and Linearity Plot

Actual Sample Detection Results

Product Stability Parameters

Applications

The Hzymes Plasmid Residual DNA Detection Kit is ideal for:

• Biopharmaceutical QC testing
• Vaccine production
• Cell and gene therapy workflows
• mRNA and viral vector manufacturing

By providing rapid, reliable, and regulatory-compliant results, it helps biomanufacturers meet global quality standards efficiently.

Conclusion

As biopharmaceutical pipelines expand, residual host DNA testing remains a crucial step to ensure product safety and regulatory compliance. With its pharmacopoeia-based primer design, ultra-sensitive qPCR detection, and fast workflow, the Hzymes Plasmid Residual DNA Detection Kit offers a comprehensive, validated, and user-friendly solution for modern biologics production.