Name: Human Residual DNA Fragment Detection Kit (2G) (PCR-Fluorescent Probe Method)
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Human Residual DNA Fragment Detection Kit (2G) (PCR-Fluorescent Probe Method)
Cat: HCP-DF03
Product Type: Host Cell Residual DNA Fragment Analysis and Detection
MtoZ Biolabs Human Residual DNA Fragment Detection Kit (2G) (PCR-Fluorescent Probe Method) is designed for the quantitative detection and size distribution analysis of residual human host cell DNA fragments in biopharmaceutical intermediates, drug substances, and drug products, supporting safety assessment and regulatory compliance in biopharmaceutical quality control workflows.
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MtoZ Biolabs Human Residual DNA Fragment Detection Kit (2G) (PCR-Fluorescent Probe Method) is designed for the quantitative detection and size distribution analysis of residual human host cell DNA fragments in biopharmaceutical intermediates, drug substances, and drug products, supporting safety assessment and regulatory compliance in biopharmaceutical quality control workflows.

Product Overview

In human cell line-derived biopharmaceutical production (e.g., CHO, HEK293, Vero), accurate characterization of residual host cell DNA fragment size is crucial for regulatory risk evaluation:

1. Unresolved DNA Fragment Size Distribution

Total DNA quantification methods fail to differentiate fragment sizes, not meeting regulatory requirements for assessing the oncogenic and infectious risks of residual human DNA.

2. Insufficient Sensitivity for Trace DNA Detection

Low-sensitivity assays cannot reliably detect fg-level residual human DNA in purified biopharmaceutical products, risking underreporting contamination and non-compliance.

3. PCR Inhibition in Biopharmaceutical Matrices

Inhibitory components in processed samples, such as excipients, detergents, and salts, can suppress qPCR amplification, compromising result accuracy.

4. Limited Specificity for Human DNA

Non-human-specific primers and probes may cross-react with DNA from other species, reducing assay reliability in multi-host-system environments.

Advantages

✅ MtoZ Biolabs’ Human Residual DNA Fragment Detection Kit quantifies four fragment sizes in parallel (75 bp, 122 bp, 244 bp, 562 bp) for comprehensive residual Human DNA size distribution analysis.

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

✅ Integrated Internal Process Control (IPC) per reaction monitors PCR inhibition and extraction efficiency in real time.

✅ Human-specific primers and fluorescent probes deliver high target specificity and low cross-reactivity with non-human nucleic acids.

✅ Compatible with mainstream real-time PCR platforms and paired with the Host Cell Residual DNA Sample Preprocessing Kit.

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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