Name: CHO Residual DNA Fragment Detection Kit (2G) (PCR-Fluorescent Probe Method)
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CHO Residual DNA Fragment Detection Kit (2G) (PCR-Fluorescent Probe Method)
Cat: HCP-DF01
Product Type: Host Cell Residual DNA Fragment Analysis and Detection
MtoZ Biolabs CHO Residual DNA Fragment Analysis Detection Kit (2G) (PCR-Fluorescent Probe Method) is a ready-to-use kit specifically designed for the quantitative analysis of fragment size distribution of residual Chinese hamster ovary (CHO) host cell DNA in biopharmaceutical intermediates, bulk drug substances, and final products, supporting regulatory compliance testing in biopharmaceutical quality control.
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MtoZ Biolabs CHO Residual DNA Fragment Analysis Detection Kit (2G) (PCR-Fluorescent Probe Method) is a ready-to-use kit specifically designed for the quantitative analysis of fragment size distribution of residual Chinese hamster ovary (CHO) host cell DNA in biopharmaceutical intermediates, bulk drug substances, and final products, supporting regulatory compliance testing in biopharmaceutical quality control.

Product Overview

In CHO residual DNA testing workflows, accurate characterization of DNA fragment size distribution is critical for safety risk assessment and regulatory compliance:

1. Inability to Characterize DNA Fragment Size Distribution

Conventional residual DNA quantification methods report only total DNA content and cannot distinguish fragment lengths, making it difficult to meet increasingly stringent regulatory expectations for biological risk assessment based on DNA fragment size.

2. Insufficient Sensitivity for Trace Residual DNA Detection

Residual host cell DNA levels in highly purified biopharmaceutical products are extremely low. Methods with inadequate sensitivity may fail to achieve reliable quantification at the fg level, leading to underestimation of contamination.

3. Sample Inhibition Causes Distorted Results

Complex biopharmaceutical matrices may contain PCR inhibitors that suppress amplification signals, resulting in falsely elevated Cq values or even amplification failure, thereby compromising quantitative accuracy.

4. Insufficient Specificity for CHO-Derived DNA Amplification

Poorly designed primers and probes may cross-react with DNA from non-CHO sources, distorting the fragment size distribution profile and reducing assay specificity in complex biopharmaceutical samples.

Advantages

✅ MtoZ Biolabs' CHO Residual DNA Fragment Detection Kit quantifies four fragment sizes in parallel (95 bp, 110 bp, 215 bp, 523 bp) for comprehensive residual DNA size distribution analysis.

✅ Detection sensitivity down to the fg level across a broad dynamic range.

✅ Integrated Internal Process Control (IPC) in each reaction enables real-time monitoring of amplification performance and sample inhibition.

✅ CHO-specific primers and fluorescent probes provide high analytical specificity and low cross-reactivity.

✅ Compatible with mainstream real-time PCR platforms and designed for use with the Host Cell Residual DNA Sample Preprocessing Kit for streamlined workflow integration.

Technical Support

1. Protocol Downloads

MtoZ Biolabs provides comprehensive experimental protocols and product manuals to help ensure smooth and reproducible workflows. For access to specific documents or detailed instructions, please contact our support team.

2. Customized Service Support

Our experienced scientists offer tailored technical assistance and customized solutions based on your specific research goals, helping you achieve optimal experimental outcomes.

3. FAQ and Expert Assistance

We provide responsive and professional technical support to address your questions efficiently. Our experts are ready to help you identify and resolve experimental challenges quickly and accurately.

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