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200–500L Drug Substance Manufacturing
GMP production center with zero-crossover production lines and unidirectional flow.
Built for Clinical Manufacturing Success
Single-Use
Platform
- Cytiva and Thermo Fisher bioreactors
- AKTA Ready chromatography
- Mobius filtration
Zero-Crossover
Design
- Unidirectional flow
- Segregated production lines
Global GMP Quality
- FDA, EMA, NMPA compliant
- 200+ client audits globally
- EU QP audit passed
- NMPA manufacturing license
200–500 L Clinical Scale
- 2,800 L total capacity
- 100+ batches/year
- Phase I/II ready
Facility Information
Flexible Upstream Capacity for Clinical Manufacturing
ProBio’s single-use upstream platform supports flexible 200–500 L production with industry-leading bioreactor systems.
Robust Downstream Processing Platform
Integrated downstream capabilities ensure efficient purification and scalable process performance.
Hybrid Filtration and Processing Capabilities
Combining single-use and reusable systems to support diverse process needs.
Resources
HAND
BOOK
GMP Manufacturing Solutions for Antibody & Protein Drugs
Advance your biologics programs with ProBio’s integrated GMP manufacturing platform from preclinical to commercialization.
HAND
BOOK
Process Characterization and Process Validation Guide
Practical guide to defining robust processes for BLA-ready biologics.
Manufacturing Center, Nanjing
Frequently Asked Questions