Consulting
Process Development
Analytical Services
GMP Manufacturing
Facility Design & Process EngineeringDesigning and engineering advanced Cell & Gene Therapy facilities. Our expertise ensures GMP compliance, process efficiency, building function and scalable solutions tailored to your manufacturing needs.
Our Services
Facility Design & Process Engineering
From Concept to Compliance: Designing for the Future of CGT
A well-designed facility is the foundation of successful Cell and Gene Therapy manufacturing. Poor planning can lead to compliance risks, operational inefficiencies, and costly redesigns, while a strategically designed facility enables seamless scale-up, regulatory approval, and long-term commercial success.
We provide facility design and process engineering services, guiding clients from early-stage planning through to operational readiness. Our expertise spans over 45 CGT manufacturing facilities worldwide, ensuring that each design is GMP-compliant, future-proof, and tailored to your specific bioprocessing needs.
Sustainability is integral to our approach and how we operate alongside priority process demands, guiding some of our decisions and practices. Our own Cell and Gene Therapy Centre was built using 98% recycled demolition materials, features solar panels and electrical car charging points, and relies on fossil fuel-free heating and cooling via heat pumps and exhaust air heat recovery. The building shell achieved a BREEAM Excellent rating. By integrating sustainable design principles, we help clients create facilities that are cost-efficient, energy-conscious, and operationally robust.
Our Capabilities
Our team of process engineers, architects, HVAC engineers and regulatory experts specialise in:
Our Facility Design & Process Engineering Services
User Requirement Brief
A successful CGT facility starts with a clear and well-structured User Requirement Brief (URB). We collaborate with stakeholders to define the process, regulatory, and operational needs of the facility, ensuring alignment between scientific requirements, business objectives, and GMP standards. Our expertise helps clients develop robust URBs that support investment decisions, risk management, and facility feasibility studies.
Feasibility Design
Feasibility designs are used for different outputs. These can include snapshot views (short duration specification, process definition costings and timelines), data for site search and selection, review of existing facilities (within company, external to company) for example.
Concept Design
Our concept design phase transforms facility requirements into practical, efficient layouts and HVAC design rationales. We ensure that cleanroom arrangements, process flows, and critical infrastructure are optimised for regulatory compliance, operational efficiency, and future scalability. By using advanced 3D visualisations, we enable clients to evaluate multiple design scenarios, ensuring the best possible configuration before committing to construction.
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Process Engineering
Effective process engineering ensures that facility layouts align with bioprocess workflows, equipment needs, and GMP regulations. Our team designs process flows, material/personnel movement strategies, and HVAC containment solutions to minimise risk and optimise production efficiency. By integrating closed-system processing, automation, and flexible cleanroom configurations, we help clients future-proof their facilities while maintaining strict compliance. We also provide process equipment specification, technical and bid analysis, ergonomic studies and follow on qualification(s).
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Why Partner with Us?
Build the Right Facility from the Start
Whether you are planning a new facility, expanding existing operations, or optimising your current setup, we provide the expertise to deliver efficient, compliant, and future-ready solutions. Contact us today to discuss your facility design and process engineering needs.