Modular Cell & Gene Therapy Center, Beijing

Project Overview：

BOTHX delivered a modular cleanroom solution for a cell and gene therapy pilot-scale manufacturing platform in Beijing. The facility, with a total area of nearly 10,000 m², is designed to comply with NMPA, FDA, and EMA GMP requirements, supporting R&D and pilot production of advanced therapy medicinal products.

Project Challenges：

• Retrofit of an aging facility with significant structural constraints
• Parallel requirements for cell therapy R&D and production
• Extremely compressed schedule requiring fast and predictable delivery

Project Solution：

BOTHX implemented a highly modular cleanroom solution, transforming a 50-year-old industrial building into a modular pharmaceutical manufacturing facility using standardized modules.

The project deployed six independent modules simultaneously to support rapid cell drug development and production. Each module covers approximately 200 m², achieves Grade B cleanliness, and integrates cleanroom systems, automation, and specialty gas utilities in full compliance with GMP requirements.

Project Results：

• Modularization rate exceeding 98%
• On-site workforce limited to 8 personnel
• Rapid assembly with project completion in 7 days
• Stable operation achieved shortly after handover

Client Value

This project demonstrates BOTHX’s capability in rapid, high-compliance modular cleanroom delivery for cell and gene therapy applications, providing a flexible, scalable, and highly predictable solution for advanced biopharmaceutical manufacturing.