ProBio's pilot manufacturing campus including a Bio-R&D Center and a Bio-MFG Center is located in Nanjing, China. The total area of the campus is 19,340m2, total capacity is 2,800L, and the annual manufacturing capacity is 104 batches. Its quality system complies with FDA, EMA, and NMPA GMP regulations. The Bio-MFG Center has passed the EU QP audit and obtained the drug manufacturing license issued by NMPA (China’s National Medical Products Administration). The Nanjing pilot manufacturing campus can support preclinical non-GMP toxicology batch manufacturing and clinical phase 1/2 GMP drug substance manufacturing.
Our GMP production center follows the internationally leading design concept and is a true "zero-crossover, unidirectional flow" plant, which meets global regulatory requirements. Strict physical isolation measures are adopted in the whole workshop, which ensure production of multiple samples at the same time. The whole process, including solution preparation, cell culture, downstream chromatography and filtration, adopts single-use technology that effectively avoids the risk of cross-contamination.
Service Highlights
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Fully Single-Use
System- Cytiva XDR, Thermo Fisher HyPerforma single-use bioreactor
- AKTA Ready single-use chromatography system
- Mobius single-use filtration system
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Zero-Crossover
Production Lines- Unidirectional flow design
- Physical segregation of production lines
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Global Quality
System- 100+ client audits globally
- Pass EU QP audits
- Drug Manufacturing Certificate issued by NMPA
Facility Configuration
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Cytiva XDR 200L×3
Cytiva XDR 500L×1 -
HyPerforma 200L×3
HyPerforma 500L×2
ÄKTA Ready 10mm×2
Mobius Flexready VF3
Large Scale Virus ×1-
ÄKTA process 10mm×2
Non-disposable
filtration skids ×1
Manufacturing Center, Nanjing
