Oligonucleotides play a crucial role in modern molecular biology, serving as essential components in therapeutics, diagnostics, and genetic research. Their effectiveness and safety depend on stringent quality control measures that ensure consistency, purity, and functionality. Alfa Chemistry's expert team strictly follows quality standards to test oligonucleotides and issue corresponding Certificate of Analysis (COA) reports to ensure that the products meet regulatory and research requirements.
Our Capabilities
Alfa Chemistry integrates state-of-the-art analytical platforms and stringent quality control protocols to guarantee the reliability of oligonucleotide products. Our comprehensive capabilities include:
- Comprehensive Compliance Testing
We provide comprehensive compliance testing for our customers. Our laboratory adheres to Good Manufacturing Practice (GMP) and ISO 9001 quality standards, ensuring that all oligonucleotides meet regulatory expectations for pharmaceutical and research applications.
- Stringent OOS and OOT Handling
Any Out of Specification (OOS) or Out of Trend (OOT) results identified during the testing process are immediately flagged, investigated, and addressed through root cause analysis, ensuring the traceability of the testing process.
- Sample Retention and Monitoring
Our Environmental Monitoring System (EMS) continuously tracks temperature and humidity levels to maintain the integrity of the samples and prevent degradation due to environmental fluctuations. Additionally, we can monitor retained samples under controlled conditions and conduct regular stability tests to observe changes in oligonucleotides over time.
Why Choose Us
Our investment in high-resolution analytical techniques ensures that every oligonucleotide meets the highest standards to support advances in molecular research, diagnostics and precision medicine.
- Regulatory Compliance and Transparency
Our quality control framework aligns with international guidelines, providing detailed COA and full traceability for each batch.
- Customization and Flexibility
Whether for research, diagnostics, or therapeutic applications, we tailor our quality testing protocols to meet specific project needs, ensuring optimal performance and regulatory adherence.
- Expert Support and Consultation
With many years of industry experience, our team provides in-depth technical guidance to help clients select the most suitable testing approaches for their applications.
Our products and services are for research use only and cannot be used for any clinical purposes.
