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.
- 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
- 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.