Commercial Viral Vector Analytical Services

From initial inquiry through development, manufacturing, testing and product release, quality is paramount. Our in-house quality and validation teams provide a full range of assay validation, testing, and analytical services to support your late-phase/commercial program.

Analytical Sciences:

• Late-Phase Analytical Assay Establishment
• Process Characterization Testing Support
• Assay Transfer to QC for Validation

Assay validation and QC testing:

• Platform assays for all vector types
• Continuous improvement for remaining “state-of-art”
• Assay qualification and validation
• Compendial assay verification
• Drug Substance and Drug Product in-process testing
• Drug Substance and Drug Product batch release testing
• cGMP stability studies
• Reference Standard qualification
• Assay bridging and product comparability studies

Question? We’re Here to Help.

Please contact us to learn more about our viral vector late-phase and commercial services.