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CAR-T Production and R&D Cleanroom Project

The client focused on the field of gene therapy, and specialized in providing CRO services—including gene therapy vector development, gene function research, drug target and efficacy studies—to support fundamental research, as well as CDMO services such as process development and testing, IND-CMC pharmaceutical research, and GMP-compliant clinical sample production for gene drug development. This project will be implemented at a 77,000-square-meter precision medicine industrial base currently under construction in the Lingang Special Area of the Shanghai Pilot Free Trade Zone. - Area: 5,500 m² + 11,400m² - Products: Car-T (cGMP/FDA/EMA)

AUSTAR Solution

System Scope: - Cleanroom and HAVC system - Electrical engineering & Water supply/drainage system - BU piping & Automatic control system - Installation of process equipment - Factory-wide information-based system
Service Scope: - Refined design - Procurement and construction - Commissioning and validation

Highlights

Computational Fluid Dyna Cleanroom Engineering for the CAR-T Production and R&D Building in the Precision Medicine Industry Base

The application of Computational Fluid Dynamics (CFD) optimizes the air distribution in key rooms of the core area, further ensuring the qualification rate of products.mics (CFD) 

AUSTAR Value & Client Benefits

• All production workshops were sterilized with VHP. AUSTAR's VHP-resistant panels are safe and reliable. The application of CFD optimized the airflow organization of key rooms in the core area. • The safe and durable use of materials in clean workshops provides long-term and reliable benefits, and the use of CFD further ensures the qualification rate of products.
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