AAV cGMP Manufacturing
With the explosive growing of gene therapy development, mass-production and packaging process of GMP grade rAAV in compliance with all applicable regulatory and standards are badly needed for IIT (PI initiated clinical trials), IND permit applications, Phases-I, -II, and -III clinical trials. Based on our own intellectual properties, from the upstream rAAV generation to the downstream isolation and purification technologies, PackGene provides mass-production services of GMP-compliant AAV, as well as GMP production line setting-up, processing and assay transfer, IND pharmacological documentation, etc. PackGene ensures AAV manufacturing services are in compliance with GMPs and all applicable regulatory and required standards for IIT and IND applications.
Note: PackGene’s FDA and EMA compliant AAV GMP manufacturing facility （~8000 square meter） is expected to begin production in 2021. For more information, please contact us: firstname.lastname@example.org
AAV Manufacturing Process
PackGene GMP-compliant services include AAV upstream production and downstream purification development, large-scale fermentation, material segregation, full traceability, document control, and a comprehensive range of quality control assays.
PackGene has developed core processing technology to greatly increase the single-batch AAV output and reduce the input cost, which brings to a lot of benefit or added value for cooperated customers.
AAV Manufacturing Facilities
PackGene AAV GMP facility was designated and built specifically for AAV vector manufacturing. We utilize bioreactors for the single-use technologies with expandable capacity in the future. Currently, our AAV GMP base is equipped with the world’s leading adhesion and suspension production system. The downstream production line is equipped with chromatography purification system and high-yield process, establishing a variety of process routes and optimization under GMP condition. PackGene is able to deliver the maximum yield of a single batch to 1E+16-17 GC/vg AAVs and a pilot-scale GMP-compliant production cycle can be accomplished within 1-2 months.
PackGene facility includes iCellis500 (~500m2 adhesion area), STR200T, Xcellerex XDR MO-50L with the single-use technology that can flexibly conduct both GMP AAV upstream production by adherent and suspension culture.
- Designed with QbD concept and optimization
- Clean environment in accordance with C+A standards
- Reaching the maximum AAV yield up to 1E+15GC-1E+17 GC/batch
- Isolated vector producing line to completely avoid cross-contamination between different vectors
- GMP-compliant pilot production cycle can be shortened to 1-2 months
- Single-use technology and water supply to ensure batch cleaning verification
PackGene can provide cGMP AAV manufacturing for your project. Please provide your project details to get a quote or technical support from PackGene.