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 development and analytics

  • 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

Process sciences laboratories

  • Assay transfer and establishment
  • Process establishment and engineering material testing
  • Process characterization testing support

QC testing

  • 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

Learn more about our end-to-end viral vector service capabilities.

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