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ProMFG 2000 L GMP Drug
Manufacturing Service

Phase III clinical & commercial
DS manufacturing

GenScript ProBio's commercial manufacturing campus is located in Zhenjiang, China with an area of 22,140m². Total capacity for drug substance manufacturing is 17,250 liters and the annual manufacturing capacity is 124 batches. Its quality system complies with FDA, EMA, and NMPA GMP regulations. The Zhenjiang manufacturing campus aims to support phase 3 clinical and commercial drug substance manufacturing. It is equipped with single-use bioreactors ranging from 50L to 2000L allowing it to handle flexible drug substance manufacturing requirements.

The Zhenjiang campus uses stainless steel buffer preparation system for materials not in direct contact with the drug. The downstream line is equipped with an 8,000 L harvest tank that is capable of supporting scale-out manufacturing mode such as 2×2000L or 3×2000L per batch.

Service Highlights

50L-2000L Flexible
DS Manufacturing

1 × 50L Bioreactor
1 × 200L Bioreactor
2 × 500L Bioreactor
8 × 2000L Bioreactor

Global Quality
System

100+ client audits globally
Comply with FDA, EMA, and NMPA GMP regulations

2000L GMP Manufacturing
Price<$100/g*

Stainless steel buffer preparation system for materials not in direct contact with the drug
8,000 L harvest tank supports scale-out manufacturing mode such as 2×2000L or 3×2000L per batch

* DS unit price (a. Fed batch process in 2000L SUB, b. 7g/L, 70% yield, c. annual batch number≥ 20 batches), including FFS and material cost