Proteintech (Wuhan) — Global Recombinant Antibody R&D & Industrialization Center
Specialized Cleanroom & Biosafety Laboratory Engineering
Scale: 5,000 sqm
Multi-Species Recombinant & Camelid Single-Domain Antibody R&D Infrastructure
Project Overview
Engineering the Precision Environment for Global Antibody Innovation
Creating a high-standard, secure, and controllable cleanroom ecosystem for multi-species recombinant antibody development.
AIPURE delivered the comprehensive purification and mechanical/electrical (M&E) infrastructure for Proteintech Wuhan’s recombinant antibody R&D building. The project encompasses specialized ISO Class 7 cell culture suites and Bio-Safety Level 2 (BSL-2) laboratories. This facility provides the critical hardware foundation for multi-species recombinant antibody development, mouse/camelid monoclonal antibody R&D, and large-scale industrialization.
Technical Highlights
Dual-Standard Integration: Simultaneous implementation of ISO Class 7 cleanliness standards and BSL-2 negative pressure containment protocols.
High-Containment BSL-2 Engineering: Deployment of independent negative pressure ventilation, unidirectional airflow, and HEPA filtration to prevent pathogen leakage.
Advanced Cell Culture Environment: Precise, multi-dimensional control of cleanliness, temperature, humidity, and pressure gradients.
Unidirectional Logistics Management: Strict architectural partitioning of clean, semi-contaminated, and contaminated zones to minimise cross-contamination risk.
Engineering Challenges & Solutions
Balancing Sterility with Biosafety Containment: Managing the conflicting requirements of a high-cleanliness cell room and a negative-pressure BSL-2 lab is a significant engineering hurdle. We designed a sophisticated airflow logic that ensures the required sterility assurance level for antibody development while maintaining secure containment for biological safety.
Complex Multi-Functional Zonal Coordination: With R&D, cell culture, and antibody preparation occurring in parallel, we implemented a rigorous “Three-Zone” isolation strategy. This ensures that personnel, materials, and air move in a strictly unidirectional manner, eliminating the risk of cross-infection.
Precision Environmental Stability for Sensitive Bio-Processes: Antibody R&D is highly sensitive to environmental fluctuations. We deployed automated control systems to maintain ultra-stable temperature, humidity, and pressure parameters, safeguarding the accuracy and safety of recombinant protein processes.
Full-Lifecycle Regulatory Compliance: From initial design to final validation, every phase was strictly aligned with biosafety regulations and medical device R&D standards. AIPURE managed the entire verification cycle, assisting the client in obtaining essential biosafety approvals and research qualifications.
Construction Content
ISO Class 7 Cell Culture Suites: Specialized cleanrooms designed for high-purity biological cultivation.
BSL-2 Negative Pressure Laboratories: High-containment zones with integrated biological safety cabinets and HEPA-filtered exhaust.
Antibody Preparation & R&D Modules: Versatile laboratory environments optimized for recombinant protein engineering.
Integrated M&E Infrastructure: Total installation of specialized HVAC, clean utilities, and automated environmental monitoring (EMS).
Why This Project Defines AIPURE
“Mastering the synergy of high-purity cultivation and rigorous biological containment.”
The Proteintech Wuhan project showcases AIPURE’s mastery in “Complex Bio-Laboratory EPC.” By delivering an industry-leading R&D base that harmonizes ISO Class 7 cleanliness with BSL-2 biosafety, we prove that our technical standards are capable of supporting the world’s most advanced biopharmaceutical innovations.
Project Conclusion
The successful delivery of the Proteintech R&D Base has empowered the client to scale their recombinant antibody and monoclonal research with confidence. All systems are operating stably, ensuring a safe and precise environment for high-end product innovation. At AIPURE, we don’t just build labs; we build the secure, high-performance foundations that allow life science leaders to enhance their global market competitiveness.
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Related Service
Cleanroom Consulting
Cleanroom Design
Construction
Product Manufacturing
Commissioning
Operation & Maintain
Contact Information
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No 18 Finance Harbor 4th Road, Wuhan, China.
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