AAV One-stop Solution

Process development for triple transfection

Support regulatory filing

AAV vector is widely used delivery vehicle for gene therapy due to its high safety and effectiveness in delivering Gene of Interest (GOI). GenScript ProBio is broadening its business in AAV services to cater to the market demand.

One-stop Solution for AAV

GenScript ProBio offers services from cell banking, process development, AAV packaging, analytical development, to GMP manufacturing and stability test for AAV vector. We are also ready to prepare reports and documents to support the regulatory filings.

GenScript ProBio is also able to produce AAV plasmids to take care of your projects from plasmids to AAV.

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.

Production of 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

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