USP Residual DNA Quantification Testing by qPCR
The United States Pharmacopeia (USP) Residual DNA Quantification Test is a critical quality assurance measure for vaccines and biologics. This test ensures that any residual DNA from the manufacturing process does not exceed safe limits, thereby safeguarding patient safety. The quantitative real-time polymerase chain reaction (qPCR) method is widely used for this purpose due to its high sensitivity and specificity.
Manufacturing of vaccines involves multiple steps including cell culture, harvesting, and purification processes. These stages can inadvertently introduce microbial or cellular DNA into the final product. Excessive residual DNA could lead to immune responses in patients, which may result in adverse effects. Therefore, quantification of residual DNA is a crucial step in ensuring vaccine safety.
The USP General Chapter <1760> provides detailed guidelines for this testing procedure. The test involves the extraction and purification of DNA from the vaccine sample followed by qPCR analysis to quantify the amount of residual DNA present. The primary goal is to ensure that the residual DNA levels do not exceed 10 ng/mL.
In our laboratory, we utilize state-of-the-art equipment such as QIAamp DNA mini kits for DNA extraction and Applied Biosystems StepOnePlus Real-Time PCR Systems for qPCR analysis. Our highly trained technicians follow stringent protocols to ensure accurate and reliable results. The testing process involves the following steps:
- Sample preparation: Samples are prepared in accordance with USP guidelines.
- DNA Extraction: DNA is extracted from the sample using advanced techniques.
- qPCR Analysis: Quantitative real-time PCR is performed to quantify residual DNA levels.
The results of this testing are crucial for regulatory compliance and quality assurance. Our laboratory adheres strictly to USP standards and guidelines, ensuring that all tests meet or exceed these stringent requirements.
Our expertise in vaccine testing includes not only the quantification of residual DNA but also other critical parameters such as sterility testing, endotoxin testing, and viral particle count. By providing comprehensive services, we help our clients ensure the highest quality standards for their products.
Applied Standards
| Standard | Description |
|---|---|
| USP General Chapter <1760> | Guidelines for residual DNA quantification in vaccines. |
| ISO 15189:2012 | International standard for quality management systems for medical laboratories. |
| EN ISO/IEC 17025:2017 | European and international standard for the competence of testing and calibration laboratories. |
Eurolab Advantages
At Eurolab, we pride ourselves on providing top-tier services that meet or exceed industry standards. Our advantages in offering USP Residual DNA Quantification Testing by qPCR include:
- State-of-the-Art Equipment: We utilize advanced equipment such as QIAamp DNA mini kits and Applied Biosystems StepOnePlus Real-Time PCR Systems to ensure accurate results.
- Experienced Technicians: Our team of highly trained professionals follows strict protocols to deliver reliable and consistent test outcomes.
- Regulatory Compliance: We adhere strictly to USP guidelines, ensuring that all tests meet or exceed these stringent requirements.
- Comprehensive Services: In addition to residual DNA quantification testing, we also offer other critical services such as sterility testing and endotoxin testing.
The combination of our advanced equipment, experienced staff, and adherence to strict protocols ensures that our clients receive the highest quality service. We are committed to helping our clients meet their regulatory and quality assurance requirements effectively.
Customer Impact and Satisfaction
Our commitment to excellence in USP Residual DNA Quantification Testing by qPCR has significantly impacted our customers, leading to high satisfaction levels. By adhering strictly to USP guidelines and using advanced technology, we ensure that the results of these tests are accurate and reliable.
Customers benefit from:
- Regulatory Compliance: Our services help clients meet regulatory requirements for vaccine safety and quality assurance.
- Improved Product Quality: Accurate testing ensures that any residual DNA in the product is well within safe limits, enhancing overall product quality.
- Enhanced Reputation: By meeting strict standards, clients can enhance their reputation as leaders in vaccine safety and efficacy.
Our customers have reported high levels of satisfaction with our services. We are dedicated to continuing this level of excellence and ensuring that all clients receive the best possible service.
