Avance Biosciences is a world leading CRO providing CGMP/GLP compliant biological testing solutions supporting the biological drug development pipeline from discovery through manufacturing.
What We Do
Biopharmaceutical drug development requires extensive biological testing for raw material release, in-process quality control, and final product characterization to secure product safety and satisfy the regulatory requirements of the FDA and other regulatory agencies.
We offer CGMP/GLP-compliant assay development, assay validation, and sample testing services to ensure strict regulatory compliance and a smooth journey to market. Using ICH guidelines, we offer a broad range of biologics quality control assays, including:
- Cell bank characterization
- Plasmid and viral vector ID testing
- Residual DNA and host cell protein testing
- Compendial assays
- Gene therapy drug substance and product release assays
- Custom assay development, validation, and more