Full lifecycle biologics factory design & turnkey construction service engineered exclusively for biomanufacturing. Our integrated EPC solutions deliver fully compliant production facilities for mAbs, mRNA, vaccines, cell & gene therapy, aligned with EU GMP Annex 1, FDA cGMP, ISO 14644 and PIC/S standards, covering conceptual layout, modular cleanroom build, utility integration, commissioning and complete GMP validation.
Biologics manufacturing imposes the strictest contamination control, biosecurity and environmental stability demands among all pharmaceutical facilities, as sensitive biomolecules, cell cultures and viral vectors are highly vulnerable to cross-contamination, temperature/humidity fluctuation and microbial intrusion. Our biologics factory design and construction service abandons generic pharma plant templates, adopting process-driven, risk-based layout planning tailored to unique bioprocess workflows from lab-scale clinical batches to full commercial mass production.
We manage every stage of factory delivery under single-source accountability: URS technical review, site master planning, classified Grade A/B/C/D cleanroom zoning, unidirectional personnel & material flow design, bioreactor suite layout, downstream purification area arrangement, dedicated WFI/PW utility skids, CIP/SIP pipeline engineering, high-efficiency bioprocess HVAC, BMS environmental monitoring system, modular cleanroom panel fabrication, civil construction, on-site assembly, FAT/SAT testing, and full DQ/IQ/OQ/PQ validation dossier handover.
For high-risk bioprocess zones including viral vector production, autologous cell therapy and live vaccine fermentation, we implement independent negative-pressure containment, separated waste neutralization areas and fully isolated processing suites to block biological aerosol leakage and cross-batch contamination. All interior surfaces use seamless, crevice-free 316L stainless steel or non-shedding antibacterial cladding resistant to repeated VHP decontamination, eliminating microbial harborage points frequently flagged by EMA and FDA inspectors.
Combining off-site modular prefabrication with on-site construction parallel workflows, we drastically shorten project timelines versus traditional masonry build, while retaining full flexibility for future capacity expansion, production modality switching and GMP standard upgrades. Our factory designs accommodate both single-use bioprocess platforms and traditional stainless steel bioreactor lines, balancing regulatory audit readiness, long-term operational cost and production scalability.
Core Competitive Advantages
1.Bioprocess-Oriented Risk-Based Layout Design
Custom zoning for fermentation, harvest, purification, formulation, aseptic fill-finish, QC labs and quarantine storage. Strict pressure cascade control and segregated flow paths eliminate mix-up and cross-contamination risks specific to complex biologic production.
2.Global Regulatory Compliance Embedded Into Construction
All structural, mechanical and utility systems built to meet latest EU GMP Annex 1, FDA 21 CFR Part 11, ISO 14644 and BSL-2 biocontainment rules. Complete traceable material certificates, airflow classification test data and audit-ready validation documents are fully supplied upon project handover.
3.Integrated Turnkey EPC, Zero Multi-Vendor Coordination Risk
In-house process engineers, cleanroom fabrication workshops, HVAC assembly lines and validation teams deliver one-contract service, avoiding conflicting technical interfaces, schedule delays and hidden extra costs caused by fragmented subcontractors.
4.Modular Construction for Fast Delivery & Flexible Expansion
Prefabricated cleanroom modules, utility skids and process suites are manufactured in controlled factory environments, cutting on-site construction period by 40%–65%. Detachable wall/ceiling panels support easy line expansion or zone reclassification without large-scale demolition downtime.
5.Optimized Biologic-Specific Utility & Energy Efficiency
Customized WFI hot-loop distribution, redundant HVAC with heat recovery and low-consumption laminar airflow units reduce facility energy consumption by 25%–35%. Intelligent EMS/BMS realizes real-time particle, pressure and humidity tracking with unalterable electronic records for full data integrity compliance.
6.Full Lifecycle Technical Support
Post-construction operation training, spare parts supply, facility renovation, GMP compliance upgrade and remote troubleshooting services are provided to sustain stable long-term biomanufacturing operation.
Main Application Biologic Modalities & Zones
- Monoclonal antibody (mAb) & recombinant protein production plants
- mRNA, plasmid DNA and viral vector gene therapy manufacturing suites
- Autologous/allogeneic cell therapy clean production facilities
- Microbial & viral vaccine fermentation, purification and aseptic filling workshops
- Bioprocess pilot labs for clinical trial material production
- GMP QC microbiology labs, buffer/media preparation rooms
- Biocontainment BSL-2 zones and biological waste treatment areas
- Sterile raw material & finished biologic warehouse suites
Whether you intend to build a new greenfield biologics campus, renovate an existing pilot plant or expand commercial biomanufacturing capacity, our professional engineering team customizes factory layout drawings, cost quotations and compliance implementation plans matching your production scale, bioprocess type and target market regulatory requirements. Contact our technical sales team today for a free project feasibility assessment and customized design proposal.
