Akeso Biopharma - Bay Area Science Park (Phase II)
EPC General Contracting for M&E Installation & Cleanroom Renovation.
Scale: 70,000 sqm
Project Overview
A Global Benchmark for Large-Scale Biopharmaceutical Manufacturing
Engineering a high-end complex for innovative drug R&D, pilot testing, drug substance (DS) production, and sterile preparation.
AIPURE served as the general contractor for this massive 70,000 sqm facility. The project represents the cutting edge of biopharmaceutical infrastructure, integrating sophisticated mechanical and electrical systems with high-standard cleanroom environments to support Akeso’s global drug development goals.
Engineering Challenges & Solutions
Integration of Nation-Leading Bio-Systems: Installing four 10,000L imported stainless steel bioreactors—among China’s largest—required sub-millimeter precision in M&E alignment and specialized airtight sealing for the cleanroom envelope.
Managing Complex Single-Use Pipelines: We designed a modular, flexible piping layout for diverse 2,000L and 500L single-use bioreactors, ensuring strict cross-contamination control through a +15Pa pressure gradient system.
Tri-Standard Regulatory Compliance: To satisfy NMPA, FDA, and EMA standards simultaneously, we executed a tiered purification strategy, achieving ISO 5 (Grade A) standards for core sterile zones with full environmental monitoring.
High-Volume Atrium Climate Control: The 6-meter high observation atrium utilized a specialized “Down-feed & Top-return” airflow design with transparent barriers to maintain visual openness without compromising laminar flow integrity in production areas.
Mega-Scale Coordination: For the 70,000 sqm site, we implemented a “Zonal Parallel Construction” model, managing frequent cross-disciplinary operations through rigid hardware isolation and continuous quality loop-closure.
Technical Highlights
Unprecedented Scale: Featuring four 10,000L stainless steel bioreactors, positioning this facility as a leader in large-capacity bio-manufacturing.
Diverse Process Support: Integrated piping and infrastructure for multiple specifications of single-use bioreactors, ensuring maximum production flexibility.
Architectural Excellence: A stunning 6-meter high observation atrium, blending industrial precision with modern architectural aesthetics for visitors and staff.
Global Compliance: Engineered and validated to meet the most rigorous international standards, successfully passing GMP/GLP certifications for NMPA (China), FDA (US), and EMA (Europe).
Construction Content
High-End R&D Labs: Specialized environments for cutting-edge biopharmaceutical research and pilot-scale testing.
Drug Substance & Preparation: Comprehensive cleanroom suites (ISO 5/Grade A) for drug substance (DS) and final product formulation.
Smart Warehousing: Modernized storage facilities designed for sensitive pharmaceutical materials and finished products.
Full M&E Integration: Total EPC management of mechanical, electrical, and plumbing systems optimized for high-availability operation.
Why This Project Defines AIPURE
“70,000 sqm of precision. Zero compromises on compliance.”
The Akeso project highlights AIPURE’s capability to manage mega-scale EPC projects that require simultaneous compliance with Chinese, American, and European regulatory frameworks. It proves that for AIPURE, no scale is too large and no standard is too high.
Project Conclusion
The Akeso Biopharma Bay Area Science Park project is more than just a 70,000 sqm construction achievement; it is a testament to AIPURE’s ability to execute mega-scale EPC (Engineering, Procurement, and Construction) projects under the most stringent global regulations.
By successfully integrating massive 10,000L bioreactor systems and passing the triple crown of NMPA, FDA, and EMA certifications, we have proven that our engineering solutions are built for the future of global medicine. We don’t just build facilities; we build the infrastructure for life-saving breakthroughs.
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Cleanroom Consulting
Cleanroom Design
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