The importance of designing for flexibility in cell and gene therapy facilities

As these therapies transition from experimental research to mainstream clinical applications, hospitals and academic medical centers are increasingly investing in specialized facilities to support their development.  

This demand is driven by the need for proximity to patients, enabling faster delivery of personalized treatments, as well as the integration of cutting-edge research with clinical care to tighten the bench-to-bedside-and-back-to-bench development loop. Regulatory support and funding incentives have also accelerated adoption, making it essential for institutions to design facilities that can adapt to evolving technologies and more stringent compliance standards.  

However, designing for flexibility in these spaces presents unique challenges — from maintaining isolation and managing complex workflows and scientific operations to accommodating future advancements without costly renovations. Exploring opportunities to address each of these factors early in the design process ensures that gene and cell therapy facilities remain agile, efficient, and prepared for the next wave of medical innovation.

Modular design for long-term adaptability 

Modular design is a key strategy for achieving flexibility, which allows facilities to adapt to regulatory changes or scale with new research programs, teams or equipment without extensive and disruptive renovations. Utilizing standardized building grids, prefabricated modular components and wall systems enables adjustments to room layouts and equipment placements with minimal disruption, ensuring the facility remains adaptable in the long run. By anticipating technological advancements such as breakthrough therapy applications, improved instrumentation efficiencies and precision, evolving gene editing tools and equipment, and automation and AI-driven technologies to enhance manufacturing processes, we can implement strategies that accommodate future needs without requiring costly overhauls.  

Another strategy is the implementation of a mechanical interstitial level. This provides access for personnel to perform routine maintenance such as mechanical filter changes, valve adjustments and re-lamping without the need to enter the cleanroom spaces. Additionally, this space can provide easy access for utility reconfiguration and other mechanical changes without disrupting ongoing critical operations and incurring costly downtime for the facility.

Short-term flexibility in daily operations 

Beyond long-term adaptability, facilities must also support short-term flexibility to accommodate the daily needs of researchers. Adjustable furniture systems, such as mobile lab benches and height-adjustable countertops, allow for quick reconfigurations within lab spaces to suit new equipment or process needs. Flexible utility connections, including quick-connect overhead service panels, can provide easy access to power, data and lab gases without extensive rewiring or plumbing, making it easier to accommodate new equipment or workflow configurations.  

Balancing flexibility with cost considerations 

While designing for flexibility offers long-term benefits, it must be approached with cost efficiency in mind. Facilities must balance adaptability and budget constraints by implementing scalable solutions that meet current and future scientific research needs without unnecessary expenditures. Proper planning ensures that resources are allocated effectively, allowing for modifications without an excessive financial burden. 

Planning for changes in regulatory compliance 

Often, medical institutions have developed cell and gene therapy facilities rather organically, based on the space available at the time of initial establishment. However, this space may not be fully suitable for production support as applications, demand and dependency on these facilities increase. Given that these facilities often involve novel and innovative therapies and processes, it is essential to consider potential future regulatory restrictions and compliance needs. While the future cannot be predicted entirely, larger commercial facilities can provide cues regarding process flows, cleanroom classifications, room pressurizations and critical redundancies when planning clinical-scale facilities. 

Maintaining unidirectional flow  

Unidirectional process flow is a critical design feature in these facilities to maintain product safety and cleanliness. Regulatory bodies like the FDA often mandate this approach to minimize cross-contamination risks. Incorporating a unidirectional flow from the outset ensures compliance and operational efficiency while reducing the need for later modifications that could disrupt operations and require re-validation. Careful planning is critical to ensure that unidirectional flows are maintained as the facility's needs change over time. Pre-designing intermediate return corridors can help and provide shortcuts to exits in larger facilities.  

Addressing viral vector challenges 

One of the biggest challenges in cell and gene therapy is viral vector production, which presents significant constraints in air flow and contamination control. These processes require carefully sequenced layouts and controlled environments for isolation to prevent cross-contamination. Additional air locks and segregation corridors can be implemented to mitigate air flow issues and maintain regulatory compliance. This underscores the importance of integrating these solutions early in the design process. 

Rethinking decontamination methods 

Decontamination is a critical factor in facility design, and chemical wipe-downs and vaporized hydrogen peroxide (VHP) have been widely used for this purpose. However, chemical wipe-downs can be time-consuming, while VHP presents its challenges, such as leaving residual films and requiring sealed environments and additional safety protocols to protect personnel. Exploring alternative decontamination methods, such as ionized hydrogen peroxide (iHP) and germicidal visible light LEDs, can enhance flexibility by reducing downtime and improving operational efficiency, ensuring that facilities remain both compliant and adaptable.  

Sight on science 

Finding opportunities for visual connectivity between cleanroom labs enhances safety, operations and collaboration. In addition to showcasing the facility to potential financial investors and donors, providing viewing windows into procedure spaces allows regulators to conduct facility inspections without having to enter a controlled space and interfere with operations. This flexibility is a considerable advantage in critical care medical centers.  

Planning for the future 

Addressing flexibility during the design phase can reduce costly renovations while allowing for seamless adaptations to evolving regulatory and scientific demands. By prioritizing flexibility from the outset, facilities can remain efficient, scalable, and resilient to the ever-evolving landscape of gene and cell therapy.