Never Been Easier

Biopharmaceutical products, including antibodies, vaccines, and cell and gene therapy products, usually rely on host cells as expression systems during manufacturing, such as CHO, E. coli, Vero cells, etc. DNA released from lysed host cells carries potential risks of tumorigenicity, mutagenicity, and immunogenicity. Therefore, effective removal strategies must be applied during downstream purification, and residual DNA levels must be controlled within regulatory limits.

Since the 2020 Edition of Chinese Pharmacopoeia officially included quantitative PCR for residual DNA testing, this method has been rapidly adopted due to its high sensitivity, good reproducibility, and ease of use compared with DNA probe hybridization and fluorescent staining methods.

However, the pursuit for better products never stops. With wider application, higher requirements for residual DNA detection have emerged: Can extraction and detection procedures be simpler? Can assay time be shorter? Are there more effective ways to prevent PCR contamination?

Host Residual DNA Detection Solution

Based on these demands, Rocgene has developed a complete residual DNA detection solution, currently covering four host cell types: CHO, E. coli, Vero, and Pichia pastoris. It features high throughput, speed, reliability, and cost-effectiveness, and is compatible with Rocgene Archimed X series qPCR systems as well as many other instruments including 7500, StepOne Plus, CFX96, etc.

Solution Features

High Throughput
For sample preprocessing, we provide magnetic bead‑based reagents, magnetic stands, and automated nucleic acid extractors to meet different throughput needs. Manual extraction with magnetic stands is suitable for low sample numbers, while high‑throughput equipment is preferred for process optimization where large numbers of residual DNA samples are often processed. The ArchiPure 96H Automated Nucleic Acid Extraction System supports up to 96 samples per run and eliminates laborious manual steps.

ArchiPure 96H Automated Nucleic Acid Extraction and Purification System

Fast
Rocgene residual DNA amplification and detection only takes 60 minutes, 1/3 faster than similar products on the market, helping you get results ahead of schedule.

Reliable
Kit standards are traceable to the national reference standards from NIFDC (National Institutes for Food and Drug Control), ensuring accurate and stable quantification.

CHO Residual DNA Detection Kit Standards
Traceable to National Reference Standards

The reagent contains a UNG enzyme + dUTP system to effectively prevent PCR aerosol contamination. UNG enzyme together with dUTP degrades aerosol contaminants from previous amplifications without affecting the detection of sample DNA in the current run. Application is simple and convenient: only a 37 °C for 2 min step needs to be added to the standard PCR program.

PCR products containing dUTP (10 ng~10 fg) were spiked into new PCR reactions to simulate amplicon contamination.
a–g: with UNG enzyme; h–n: without UNG enzyme; o: no amplicon added

Cost‑Effective
Primer‑probe mix and enzyme mix are pre‑blended into a single tube, allowing direct loading with no reagent waste and easier operation.

Product Information