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
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.











