• PG13 Residual DNA Fragment Detection Kit (PCR-Fluorescent Probe Method)
  • Cat: HCP-DF05
  • Product Type: Host Cell Residual DNA Fragment Analysis and Detection
  • MtoZ Biolabs PG13 Residual DNA Fragment Detection Kit (PCR-Fluorescent Probe Method) is designed for the quantitative detection and size distribution analysis of residual PG13 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 PG13 Residual DNA Fragment Detection Kit (PCR-Fluorescent Probe Method) is designed for the quantitative detection and size distribution analysis of residual PG13 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 PG13 residual DNA detection workflows, accurate fragment size characterization is essential for risk-based regulatory evaluation of biopharmaceutical products:

 

1. DNA Fragment Size Distribution Unresolved

Total residual DNA quantification methods fail to distinguish fragment size, limiting their utility in evaluating the biological risk associated with residual PG13 host cell DNA in biopharmaceutical products.

 

2. Insufficient Sensitivity for Trace DNA Detection

Low-sensitivity assays may fail to detect fg-level residual PG13 DNA in purified biological samples, increasing the risk of underestimating trace contamination.

 

3. PCR Inhibition in Biopharmaceutical Matrices

Inhibitory substances in processed samples may interfere with qPCR amplification, resulting in delayed Cq values, abnormal amplification curves, or inaccurate quantification.

 

4. Limited Specificity for PG13

Non-PG13-specific primers and probes may cross-react with non-target DNA, reducing assay reliability in complex manufacturing environments or multi-host production settings.

 

Advantages

MtoZ Biolabs’ PG13 Residual DNA Fragment Detection Kit quantifies three amplicon sizes in parallel (118 bp, 212 bp, and 502 bp) to enable residual PG13 DNA fragment size distribution analysis.

 

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

 

Integrated Internal Process Control (IPC) in each reaction monitors PCR inhibition and overall assay performance in real time.

 

PG13-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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