5000m2 with 5 floors
15000m2 with 4 floors
200L*2, 500L*2 and 2000L*2 bioreactors, 4 production lines
> 100 batches, 20 programs and multi-serotypes
Dosed >100 pts in 15 trials
meet China, US and EU Standards
One co-development. Two MNCs' due diligence
ISO14001\ISO45001\ NMPA GMP Certification
Suspension HEK293 cell
High yield and packaging efficiency for multiple AAV serotype
MCB/WCB were established and identified according to Chp, USP and EU standard
Stability verified in large scale and long term culture
| AAV serotype | Harvest titer by ddPCR |
|---|---|
| AAV2 | 4.00E14 vg/L |
| AAV5 | 1.34E15 vg/L |
| AAV8 | 1.40E15 vg/L |
| AAV9 | 1.20E15 vg/L |
| AAVXL32.1 | 1.6E15 vg/L |
The AAV platform has end-to-end R&D and production capabilities from product genetic sequence to final production. We also have experience in the development and production of gene therapy drugs throughout their life cycle, including phase III clinical drug production, commercial drug production, process characterization, process performance qualification and BLA(NDA) document preparation and submission.
