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.
* 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
Cytiva AKTA process×4
Manufacturing Center, Zhenjiang