Gene Therapy Viral Vector CDMO Services

As a trusted viral vector CDMO, we understand there is no single production strategy that works best for all CGMP viral vector manufacturing projects. We offer the flexibility of multiple production methods and the expert knowledge to help you decide which process will best meet your needs. If you’re not ready for CGMP viral vector manufacturing, please see our research-grade viral vector packaging services for more information.

We have the experience and dedication to quality required to scale up your viral vector gene therapy project into a patient-ready product. We offer a range of viral vector production platforms:

  • CGMP AAV Production
  • CGMP Adenovirus Production
  • CGMP Lentivirus Production
  • CGMP Retrovirus Production
  • Custom CGMP Virus Production

Viral Vector CGMP Process Development

The development of an efficient viral vector manufacturing process is critical in order to ensure that the large amount of material needed for clinical trials is produced efficiently, safely, and consistently. Our Process Development services help achieve consistent CGMP production and reduce costs for both clients and patients. Starting your project with our CGMP Process Development team ensures that your project meets FDA regulatory requirements with reduced costs going forward and high quality standards.

  • Explore Our Viral Vector Process Development Services
    Production StagePurposeAvailable Services
    UpstreamOptimization of parameters for scale-up and production, including culture and transfection conditions
    • Process optimization using scale-down models (iCELLis® Nano, T-flask, shake flask, 10L stir tank reactor)
    • Cell line engineering and adaptation
    • Media/feed screening and optimization
    • Transfection/infection optimization
    • High-density cell culture and transfection/infection
    • Harvest, lysis, and clarification
    DownstreamOptimization of product recovery, purification, and formulation procedures
    • Column and membrane chromatography (affinity, ion exchange, size exclusion, mixed-mode, automated chromatography platforms)
    • Bioprocess filtration (tangential flow, hollow fiber, depth filtration)
    • Ultracentrifugation
    CGMP QC ServicesEnsures safety, potency, purity, and identity of final CGMP drug product
    • Formulation studies
    • Vial compatibility studies
    • Viral clearance studies
    • Viral stability studies
    • Long-term stability studies
    • Assay development

    1. The upstream phase concerns optimization of all procedures involved in scale-up and production of the material.
    2. The downstream phase involves optimization of procedures related to recovery, purification, and concentration of the final product.
    3. The final phase of process development includes assay development related to product safety, potency, purity, and identity.