AAV cGMP Manufacturing
Note: PackGene’s FDA and EMA compliant AAV GMP manufacturing facility （~8000 square meter） start to begin production in 2021. For more information, please contact us: firstname.lastname@example.org
AAV Manufacturing Process
AAV Manufacturing Facilities
PackGene AAV GMP facility was designated and built specifically for AAV vector manufacturing. We utilize bioreactors applying 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, 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. 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-50/200/500L 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