qPCR Viral Genome Copy Number Testing in Vaccines
The quantitative polymerase chain reaction (qPCR) is a powerful tool utilized to determine the viral genome copy number within vaccines. This method provides accurate and precise quantification of RNA or DNA sequences, which is essential for ensuring vaccine quality and potency.
Eurolab's qPCR-based testing ensures that the viral genome copies in vaccines are consistent with expected levels. This process involves several steps: specimen preparation, amplification reactions, and data analysis using real-time PCR technology. The precision of this technique allows us to identify any discrepancies between actual and target values.
Our approach adheres strictly to international standards such as ISO 13428-2 for qPCR methods in pharmaceutical testing. By following these guidelines, we ensure that our results are reliable, repeatable, and compliant with regulatory requirements worldwide.
| Parameter | Description |
|---|---|
| Sample Preparation | The sample undergoes extraction and purification processes to isolate the viral RNA or DNA. |
| Amplicon Design | Carefully designed primers and probes specific to the target sequence optimize amplification efficiency. |
| Reaction Conditions | The reaction mixtures are kept at optimal temperatures and pH levels throughout the procedure. |
| Data Analysis | Real-time monitoring of fluorescence intensity allows for accurate quantification of target copies per microliter. |
Scope and Methodology
- Sample Collection: Proper collection of biological samples is crucial for accurate testing.
- Extraction: Viral nucleic acids are extracted using appropriate reagents to ensure high purity.
- Dilution: Samples must be appropriately diluted before analysis to prevent saturation effects.
- Amplification: Real-time PCR amplifies the target region, producing a fluorescent signal proportional to the number of copies.
Eurolab Advantages
We offer state-of-the-art facilities and experienced personnel who can perform qPCR viral genome copy number testing efficiently. Our team understands the importance of adhering to stringent quality control measures, ensuring every result reflects true vaccine content.
- Highly skilled professionals with extensive experience in pharmaceutical testing.
- Access to advanced laboratory equipment including real-time PCR machines and automated sample preparation systems.
- Comprehensive support services available throughout the testing process from initial consultation through final report issuance.
Why Choose This Test
- Precision: qPCR provides highly accurate measurements of viral genome copies, crucial for maintaining vaccine efficacy.
- Speed: Rapid turnaround times enable timely release decisions without compromising quality standards.
- Regulatory Compliance: Adherence to international standards ensures compliance with global regulations regarding pharmaceutical products.
