Viral vector assay validation, testing, and analytical services quickly advance cell and gene therapies from pre-clinical development to scale-up and commercial readiness.
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 to ensure commercial readiness for cell or gene therapy products.
Our range of extensive analytical capabilities includes:
- Assay establishment, customization or development across all vector types
- Process development testing support
- Pre-clinical material testing
- Transfer of assays to QC for qualification/validation
- Assay transfer and establishment
- Process establishment and engineering material testing
- Process characterization testing support
- Compendial assay verification, assay qualification and validation
- QC drug substance and drug product in-process and batch release testing
- cGMP stability studies
- Reference standard qualification
- Assay bridging and product comparability studies