AAV vector is widely used delivery vehicle due to its high safety and effectiveness in delivering Gene of Interest (GOI). ProBio is broadening its business in AAV services to cater to the market demand.
One-stop Solution for AAV
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.
ProBio is also able to produce AAV plasmids to take care of your projects from plasmids to AAV.
- To evaluate the titer and function of AAV
- Small scale production evaluation
- Upstream Process Development
- Downstream Process Development
- Formulation Process Development
- Verification run
- QC and release
- Analytical Method Development
- Analytical Method Qualification
- GMP Manufacturing
- Quality Control and Release
- Accelerated Stability Test
- Influencing Factor Stability Test
- Long-term Stability Test
- 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
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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
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