Wuxi Apptec

We provided architectural and engineering services for a new state-of-the-art cGMP center in compliance with clinical and commercial manufacturing requirements established by ICH, EMA, PIC/S, and FDA. The first floor was designed for autologous cell therapy clinical manufacturing and the second floor for segregated BSL-2 viral vector production. The facility accommodates multiple production technologies including roller bottles, cell stacks, hyper stacks, wave bags, stainless steel packaged bioreactor systems and single-use bioreactors up to 2,000 liters. The facility is also configured with cleanrooms meeting EU Grades B-D and includes all of the clean support systems for cGMP production including WFI, CDA, CO2, O2, N2, RO/DI, and environmental monitoring.