CMC
Pipleline
Developing Products
That Are Potent, Enabling,
Novel and Safe
That Are Potent, Enabling,
Novel and Safe
Cell expansion
01
Virus infection
02
Virus harvest
03
Virus purification and buffer exchange
04
Filtration
05
Final drug product
06
Bioreactor
01
Filtration
02
Chromatography
03
Characterization QC
04
Formulation
05
GMP Production
06
Cost Leadership with
Innovative Technology
-
Fixed-bed Bioreactor• Evolution from cell factory to bioreactor to achieve significant higher productivity and cost reduction
-
Serum-free Culture• Enhanced purity & quality
• Productivity ≥ serum-supplemented media
-
Live Virus Formulation• Conventional way requires -80 °C / lyophilization
• Proprietary formulation allows -20 & 4 °C
-
Engineered Cell Lines• Engineered cell lines to support stable and efficient manufacturing
-
Lead-edge Bioreactor• Upstream process using bioreactor benefiting future scalability
-
Optimal Purification• Optimized chromatographic technique to improve purity and yields
-
Entire Process with SUT• Single Use Technology to ensure GMP-standard sterility
Pilot-scale
Shenzhen Base
In accordance with cGMP standard, using highest sanitation to ensure sterility and safety
Fully support Phase I/II study of key pipelines to advance clinical trial progress
Commercial-scale
Suzhou Base
State-of-the-art facility for GMP manufacturing to support:
Global clinical trials
Partnership programs
Scaling of manufacturing
Wuzhong, Suzhou
