Vero host-cell DNA Quantitation Kit from China

Core Unique Advantage

1.Ultra-Sensitive Vero-Specific Quantitation for Vaccines: Achieves an industry-leading Limit of Quantification (LOQ) of 0.3 fg/μL and a broad linear range of 0.3fg/μL to 300pg/μL, with a regression coefficient (R²) nearly 0.9999 and amplification efficiency of 100.627%—ensuring detection of even trace Vero residual DNA in viral vaccine samples, the strictest requirement for vaccine QC. CV values <30% for all concentrations ≥0.3fg/μL and accuracy deviation within 30% guarantee data integrity for regulatory submissions.

2.Two Hours Rapid Workflow with Room-Temp Sample Prep: Reimagines Vero Residual DNA testing for vaccine manufacturing efficiency—only 3 simple steps for sample preparation, completed in just 20 minutes, with all residual DNA sample prep components stable at room temperature. No costly cold chain storage or complex protocols required, and a single ready-to-use qPCR MIX eliminates hands-on error and reduces lab time. The entire assay (sample prep + qPCR amplification + quantitation) is finished in 2 hours—far faster than generic residual DNA kits, accelerating vaccine production QC timelines.

3.Reliable Performance for Real-World Vaccine Samples: Delivers a 70%-130% recovery rate for both simulated and actual Vero cell DNA samples, including low-concentration trace contaminants and high-concentration in-process samples—validating consistent performance in the complex matrices typical of viral vaccine production (e.g., cell culture supernatants, vaccine bulk). Within-run and total precision both show CV <30%, meeting the strict GMP requirements for vaccine quality control and batch-to-batch consistency.

4.User-Friendly Design for GMP Facilities: No specialized equipment or advanced lab training required—compatible with all commercial real-time qPCR instruments, and the single-component qPCR MIX reflects DuckyBio’s advanced formulation technology, minimizing human error and streamlining routine QC testing. Every kit undergoes rigorous batch-to-batch validation, with detailed performance data included to support your viral vaccine regulatory compliance efforts.

Kit Performance & Validated Results

Rigorous experimental validation confirms the kit’s unrivaled performance for Vero residual DNA quantitation in viral vaccine QC scenarios:

• Amplification & Linearity: Seven concentration Vero DNA samples (0.3fg/μL-300pg/μL) show a regression coefficient close to 0.9999 and amplification efficiency of 100.627%, with perfect, reproducible amplification curves for all concentrations.
• Precision & Accuracy: CV values as low as 6.4% for high-concentration samples (3fg/μL) and <30% for all concentrations ≥0.3fg/μL; accuracy deviation within 30% for all tested Vero DNA levels, ensuring reliable quantitation for trace contaminants.
• Recovery Rate: 70%-130% recovery for both simulated Vero DNA samples (0.3fg/μL to 300pg/μL) and actual vaccine production spiked samples, validating performance in real-world bioprocessing matrices.
• Sample Prep Efficiency: 3 simple steps for sample preparation, completed in 20 minutes—no centrifugation or specialized reagents required, with all prep components stable at room temperature for simplified inventory and storage.

Why Choose Our Vero resDNA Quant Kit for Vaccine Production?

Key Applications

• Viral vaccine manufacturing QC (influenza, COVID, polio, and other Vero cell-derived vaccines)
• Vero cell line bioprocess development and scale-up testing
• In-process Vero residual DNA detection (cell culture, purification, formulation)
• Final viral vaccine product residual DNA quantitation
• Bulk vaccine substance quality control for regulatory compliance
• GMP-compliant biopharmaceutical testing for Vero host-cell DNA
• African green monkey Vero cell line characterization and QC

Technical Specifications

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