Cell And Gene Therapy Facility Design/Build Strategies That Spark Brilliance
By Billy Garrett and Steven Ritchie
Momentum in the cell and gene therapy (C>) space has reached a fever pitch—and so has the launch of new laboratories to support it. More than 20 FDA approved therapies and 1,000 clinical trials are registered and underway, according to Cell & Gene’s Therapy Investment Outlook. Additionally, in 2021 roughly one-third of private equity and venture capital investment in life sciences went to cell and gene therapy.
Investors are also seeing the value in investing in C> facilities such as viral vector and autologous facilities. But these specialized facilities have complex infrastructure needs and require expensive equipment. In other words, the stakes are high.
Six ways to design the most productive cell and gene therapy facility
The following are six key considerations for designing, building, occupying, or investing in these facilities.
1. Design an agile layout. In C>, products like cancer therapies or vaccines have shelf lives of less than 12 months. Innovation relies on flexibility and turning out small batches with agility. Versatile design elements like rollable equipment and furnishings can enable the production team to reset based on new needs. Choose mobile instead of built-in casework to better move services around as needed.
Details like floor-to-ceiling clearance, corridor widths, and load-bearing capacity requirements are essential. Confirmation will ensure that heavy or cumbersome equipment can be moved in, and around, as needed. These small-scale production spaces can require large equipment including fermentation tanks and bioreactors. Place larger pieces of equipment early in the design process so the remainder of the lab can be designed around them.
Finally, features like flexible hosing and extra drop points for gases could prove valuable in the future for quick change outs of outdated equipment.
2. Consider elevated air exchange infrastructure needs. Given some C> environments need as many as 50 air exchanges an hour with 100% fresh air to reduce the risk of contamination, the facility must support the infrastructure needed, such as large AHU/HVAC systems and expansive ductwork and piping.
3. Think local regarding waste disposal. Emissions and EPA waste licensing standards are key considerations in facility design. To start, identify the main accumulation area (MAA) for correct waste disposal (non-hazardous vs hazardous vs biohazardous). Local standards can vary greatly; there is little standardization even within the same country or state. Start by identifying:
- Current vs. future production
- Waste material generated per batch
- Concentration of waste
- Disposal method (catch/release, off-site disposal, third-party removal)
4. Beware your dust particle count. Not every facility needs to meet clean room standards. However, there are a variety of tactics for managing airborne and surface dust particles. Something as simple as using light switch plates with tapered edges can keep dust and other impurities from collecting.
5.) Can’t find a lab? Convert a traditional office. The life sciences industry is undersupplied in all types of spaces. Especially in industry hubs like Boston and San Diego, companies are considering standard office buildings and other property types for conversion. If adaptive reuse is an option, the existing building must be renovated to accommodate the robust heating, ventilation and air conditioning systems required for good manufacturing process (GMP) standards.
6. Create innovative space. C> research and production is some of the most innovative work today. But it’s about so much more than just a lab. It’s about creating a work environment where people feel comfortable pledging tireless dedication to curing disease and advancing other major medical discoveries.
Sophisticated discovery demands a sophisticated facility
From workplace strategy through design to construction, keep in mind how people experience the entire space. Designing and building a coveted laboratory facility could help your organization win the war for talent via workspaces where that talent can thrive.
Billy Garrett is director of project management, Unispace Life Sciences (formerly Biopharma Engineering); and Steven Ritchie is senior associate – technical design, Unispace