Viral Vector Analytical Development and Testing

From initial inquiry through development, manufacturing, testing and product release, quality is paramount. Our in-house quality and validation teams provide a range of assay development, testing, and analytical services.

Analytical development:

• Assay establishment, customization, or development:
  • Platform assays for all vector types
  • Continuous improvement for remaining “state-of-art”
• Process development testing support
• Pre-clinical material testing
• Assay transfer to QC for qualification

QC testing:

• 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 development and clinical services.