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2,000L Drug Substance Manufacturing
2,000L manufacturing scale for biologics to support phase III clinical and commercial drug substance manufacturing.
GMP-Compliant Manufacturing for Global Regulatory Markets
Flexible Scale-Up
- 50L–2,000L single-use bioreactors
- Phase III and commercial
- Demand-driven capacity
Commercial-Ready Capacity
- 22,140 m² GMP campus
- 17,250L total capacity
- Up to 126 batches/year
Global GMP Quality
- FDA, EMA, and NMPA compliant
- 200+ client audits supported globally
- Inspection-ready quality systems
Scale & Cost Efficiency
- 8 × 2,000L bioreactors
- 8,000L harvest tank
- Supports scale-out
50–2,000 L
- Phase III and commercial programs
- Global GMP-compliant (FDA/EMA/NMPA)
- 200+ client audits
- 8,000L scale-out capability
- Cost-efficient manufacturing
Problem-Solving Expertise
DO Probe Failure
Discover how ProBio maintained process control and protected batch performance despite DO sensor failure.
Wave Single-Use Bag Leakage
Learn how ProBio contained a wave bag leak and protected cell culture integrity during N-1 operations.
High Concentration & Low Endotoxin
See how ProBio achieved demanding concentration and endotoxin targets while preserving product quality.
Resource
HAND
BOOK
GMP Manufacturing Solutions for Antibody & Protein Drugs
Advance your biologics programs with ProBio’s integrated GMP manufacturing platform from preclinical to commercialization.
Manufacturing Center, Zhengjiang
Frequently Asked Questions