AMPIGENE® CHO DNA Detection Kit (qPCR)

• Highly sensitive qPCR detection of residual CHO DNA — LOD 0.3 fg/µL, LOQ 3 fg/µL
• Results in under 5 hours (extraction + qPCR)
• Broad dynamic range: 3 fg/µL – 0.3 ng/µL (6-point standard curve)
• CHO DNA standard included for quantitative analysis
• Platform agnostic — runs on any FAM-capable qPCR system, no lock-in or requalification
• Linearity R² > 0.99; Precision ≤ 15% CV
• Sample recovery: 80–120%
• ICH Q2(R2) method validation report available at no extra cost
• Suitable for Research and Manufacturing Use

The AMPIGENE® CHO DNA Detection Kit (qPCR) enables you to detect sub-picogram levels of residual DNA from Chinese Hamster Ovary (CHO) cell lines in biopharmaceutical products using probe-based quantitative PCR. The kit delivers results in under 5 hours when paired with the AMPIXTRACT™ Magnetic Bead Extraction Kit (ENZ-GEN514, sold separately), providing a complete extraction-to-answer workflow for in-process monitoring and final product release testing.

The kit includes a well-characterized CHO DNA standard (30 ng/µL) for generating a 6-point standard curve spanning 0.3 ng to 3 fg/µL — providing the broad dynamic range needed to test samples with variable DNA levels in the same assay, from in-process samples with higher amounts of DNA to final drug substance with trace-level residuals.

<p Enzo’s AMPIGENE® CHO DNA Kit is fully platform agnostic — it runs on any FAM-capable real-time PCR system with no lock-in or requalification required.

Probe-Based qPCR for Highly Sensitive Quantitation

The AMPIGENE® CHO DNA Detection Kit provides highly sensitive detection of CHO DNA, allowing you to use small sample volumes to generate accurate results. The broad linear range of the probe-based assay allows you to test samples with variable levels of CHO DNA in the same run — from in-process samples with higher DNA amounts to bulk drug substance with very low residual levels. Linearity (R² > 0.99) is demonstrated across the full 6-point standard curve range of 3 fg/µL to 0.3 ng/µL.

Residual host cell DNA from CHO cell lines is a critical quality attribute in biopharmaceutical manufacturing. ICH Q6B and FDA/WHO guidelines establish strict limits for residual DNA in final drug products. Quantitative PCR (qPCR) is the gold-standard method for residual HCD quantification, offering high sensitivity, specificity, and throughput.