Viral Safety Reference Material

From assay development to adventitious agent detection, Viral Safety Viral Reference Materials provide a reliable foundation for critical viral safety applications. These purified, replication-competent viral stocks support method suitability studies, LOD/validation studies, and NGS-based applications. Characterized for lot-specific genomic concentration and, where applicable, infectivity, they are supplied as high-titer frozen liquid stocks for flexible downstream dilution and use. Each virus-specific material is developed to support testing strategies aligned with ICH Q5A(R2) and WHO-relevant adventitious virus panel concepts and includes a lot-specific Certificate of Analysis.

A lot-specific Certificate of Analysis (CoA) is included with every Viral Safety Reference Material and provides the measured characterization data for that lot. View an example CoA to learn more about the information available. If you need a digital copy of a CoA, simply contact our Customer Service team at info@microbiologics.com. We're happy to help and can quickly provide the documentation you need.

Highlights

• Purified viral reference materials for viral safety applications
• Supports adventitious agent detection, including NGS-based workflows
• Developed to support workflows aligned with ICH Q5A(R2) and WHO-relevant adventitious virus panel concepts
• Designed for assay development, method suitability, LOD/validation, recovery, and matrix effect studies
• Includes DNA and RNA viruses across enveloped and non-enveloped structures
• Supplied as frozen liquid stock with no reconstitution required
• High-titer material intended for downstream dilution
• Can support whole-virus extraction workflows when extracted and spiked into the customer’s process
• Lot-specific Certificate of Analysis reports measured characterization attributes
• Ships on dry ice

Applications and Test Methods

• Viral Safety Testing
• Adventitious Agent Detection
• Next-Generation Sequencing
• NGS-Based Adventitious Virus Detection
• LOD/Validation Studies
• Assay Development
• Method Suitability Studies
• Biological Recovery Assessment
• Matrix Effect Evaluation
• Method Performance Evaluation
• Investigation Support