We deliver specialized, GMP-aligned facility design solutions tailored exclusively for Cell and Gene Therapy (CGT) manufacturing plants, covering CAR-T cells, stem cell products, viral vectors, gene editing therapeutics and advanced biological therapies. All design frameworks fully comply with FDA cGMP, EU GMP, ISO 14644 and global advanced therapy medicinal product (ATMP) guidelines. Adopting cell-safety prioritized and closed-process design principles, our solutions address the ultra-rigorous requirements of low-biomass production, personalized batch manufacturing and high-risk viral operation, constructing audit-ready, contamination-free manufacturing environments compliant with international CGT regulatory standards.
Our core design focuses on strict biosafety isolation, cross-contamination prevention and ultra-clean environmental stability for high-value CGT production. We implement scientifically partitioned functional zones for cell isolation, genetic modification, viral vector culture, cell expansion, sterile filling and cryopreservation, with fully independent personnel, material and waste flow routes. Precision ISO 5 to ISO 8 graded cleanroom layout, unidirectional airflow organization and customized positive/negative pressure gradients effectively isolate active viruses, modified cells and exogenous pollutants. Specialized HVAC purification, independent process gas supply, low-temperature storage systems and biosafety waste disposal mechanisms ensure full-process environmental controllability and batch production safety.
Covering full-lifecycle customized engineering services, our scope includes overall plant master planning, CGT-process-driven spatial layout optimization, closed production line design, cleanroom sanitary structure construction, complete MEP and utility system configuration, intelligent environmental monitoring deployment and full GMP validation documentation support. We optimize closed single-batch workflow layouts to eliminate cross-batch contamination risks, adapting to personalized small-batch CGT manufacturing characteristics. All structural and pipeline designs feature dead-zone-free surfaces, high cleanability and full sterilization accessibility, perfectly matching rigorous ATMP production and quality control specifications.
Empowered by in-depth advanced biotherapy engineering experience and cross-standard compliance capabilities, our CGT facility design achieves optimal integration of biosafety, process specificity and future scalability. Professional risk-based layout design eliminates regulatory non-compliance risks and post-construction rectification costs, greatly accelerating project certification progress. Flexible modular space and reserved intelligent upgrading interfaces support new process iteration, multi-product switching and future capacity expansion. We help biotech enterprises build high-standard, fully compliant CGT manufacturing bases to support advanced therapy research, clinical conversion and commercial-scale industrialization.
