AAV Production Workflow

AAV manufacturing solutions for gene therapy commercialization

The rapidly growing interest in AAV-based gene therapies has led to the need for more cost-effective and scalable AAV vector production platforms.

Thermo Fisher Scientific offers innovative products and services that are designed to help accelerate your gene therapy projects. With solutions that span the entire AAV production workflow, our aim is to provide exceptional products and expertise to help customers develop breakthrough therapies.

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From DNA vector selection to large-scale production and purification, we have solutions to meet your needs.

• DNA vectors
• Cell culture and transfection
• Single-use fermenters
• Gibco peptones
• Affinity, ion exchange and hydrophobic interaction chromatography resins
• Residual DNA quantitation
   

• Invitrogen GeneArt Gene Synthesis services

• CTS AAV-MAX Helper Free AAV Production System (mammalian)
• CTS Viral Production Cells 2.0 (mammalian)
• SF9 cells in Sf-900 II SFM (insect)
• Benchtop bioreactors
   

• HEK Media Panel
• Gibco peptones
• Bioprocessing liquids
   

Effective and scalable methods for a high-purity and high-yield AAV product is critical for commercial success. We offer high-performance, scalable purification and polishing resins for a broad range of serotypes.

• AAV affinity chromatography resins
• Anion exchange chromatography resins
• Cation exchange chromatography resins
• Hydrophobic interaction chromatography resins
   

• Single-use mixers
• Custom buffers and bags
• Fluid transfer solutions
   

To help ensure regulatory approval of the final AAV product, QC testing must be implemented. We offer rapid molecular methods for containment and impurity testing for common AAV production workflow targets.

• Mycoplasma detection
• Residual host cell DNA quantitation
• Residual plasmid DNA quantitation
• Quantitative Sf-Rhabdovirus DNA Kit
• Digital PCR system
   

Once the final product has been purified and has passed the necessary quality and release testing criteria for clinical use, it is ready for formulation, final fill and finish.

• Critical environment containers
• Fluid and transfer solutions
• Sterile drug dosage forms (services)
   

Our cell and gene therapy CRO solutions support customers through the unique demands gene therapy clinical trials call for. The extensive breadth and depth of therapeutic and functional expertise have guided a diverse range of cell and gene therapy assets through the development pipeline.

Our Viral Vector Contract Manufacturing Services support clients from drug development to full-scale manufacturing. In addition to product release, stability testing, process and analytical qualification, and custom cell line engineering, we provide global quality compliance and regulatory support.

Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.