Our integrated one-stop turnkey engineering solution delivers full lifecycle services for biologic drug factories, covering conceptual layout design, process flow simulation, cleanroom modular construction, HVAC & purified utility systems installation, full bioprocess equipment integration, automation control networking, FAT/SAT commissioning, complete IQ/OQ/PQ validation packages, regulatory consulting and on-site personnel training.
Serving monoclonal antibodies, recombinant proteins, viral vectors, mRNA vaccines, cell therapy and gene therapy production projects, the solution seamlessly connects upstream seed culture & bioreactor suites, harvest clarification stations, downstream purification zones, formulation & aseptic fill-finish areas, QC laboratories, cold chain storage and supporting auxiliary buildings. We harmonize sanitary process equipment (single-use systems, stainless steel bioreactors, buffer/media preparation skids, TFF, chromatography systems) with classified GMP cleanrooms, WFI generation, pure steam, compressed air and exhaust treatment utilities into a unified, fully coordinated production ecosystem.
Centralized PLC+HMI automation architecture realizes unified recipe management, real-time parameter monitoring, batch data archiving, audit trails and electronic signatures, fully complying with cGMP, 21 CFR Part 11, FDA and EMA regulatory standards. Modular design supports phased capacity expansion and rapid product line switchover, adapting flexibly from clinical pilot plants to large-scale commercial manufacturing campuses.
By consolidating architecture, MEP, process equipment, automation and validation under a single general contractor, we eliminate multi-party coordination conflicts, shorten overall project delivery cycle, reduce investment risks and interface management costs for owners. Clients receive a fully operational, audit-ready biologics facility upon handover, enabling fast pipeline transformation from lab R&D to commercial drug launch.
