Packaging Test
  • To evaluate the titer and function of AAV
Demo Run
  • Small scale production evaluation through platform process
Process Development (PD)
  • Upstream Process Development
  • Downstream Process Development
  • Formulation Process Development
Verification Run
  • 3 verification runs
  • QC and release
Analytical Development
  • Analytical Method Development
  • Analytical Method Qualification
GMP Manufacturing
  • GMP Manufacturing
  • Quality Control and Release
Stability Test
  • Accelerated Stability Test
  • Influencing Factor Stability Test
  • Long-term Stability Test
Regulatory Support
  • Report and document preparation for regulatory filing

Among the various ways of producing AAV vector, the most mature, versatile and cost-effective one is triple transient transfection system. Three plasmids, helper plasmid, Rep/Cap plasmid and AAV transfer plasmid, are co-transfected in packaging cell line, such as HEK 293, to manufacture AAV.

Professional

Professional team averagely over 10 years of virus production experience

Efficiency

Process development for specific project based on platform experience

Cutting-edge technology

ddPCR for titer measurement
AUC for full ratio measurement

Guarantee Delivery

Strict product release criteria
Document preparation for regulatory filing

  • Proprietary suspension cell line PowerSTM-293

    • Compliant for IND application and commercialization
    • Stable AAV packaging ability within different AAV serotypes, AAV 2, 5,8,9...
    • 30%~50% higher crude titer than commercial cell line
    • Scalable production process
    • Up to 200 L manufacturing scale
  • AAV Benefits

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