There are many factors to consider in the site selection and facility design of cell therapy facilities. As sites are evaluated, one consideration is whether the building should have a horizontal (single-story) or a vertical (multi-story) massing. This article summarizes IPS’ experience and findings over the last five years of consideration factors behind the vertical versus horizontal decision.
Functional Spaces and Scale-Out
There is a natural fit for stacking operations like buffer and media preparation above cell culture in large-scale stainless-steel biotech facilities. In cell therapy facilities, there isn’t a process or material movement driver for vertical configuration. At the same time, long travel distances in a single-story facility may not be fit for function, depending on what material is traversing that distance and when in the process. Mapping out the movements within the process with allowable time durations can help determine what functions need to be adjacent to each other and where logical breaking points are in the process. For example, after formulation with dimethyl sulfoxide (DMSO), there is a time-critical need to fill and freeze the product grouping those functions. Some breakpoints are clear: for instance, moving frozen apheresis materials from receiving to cell selection can take as long as the CryoPod can hold temperature. Other breakpoints that may not have been characterized initially may have to be considered due to space or distance concerns; for example, evaluating how long the product can stay at ambient conditions between cell expansion and formulation. The concept of mapping out movements is important for fitting within a smaller footprint of a multi-story building, as well as in scale-out of horizontal facilities.
We ask our clients what makes the most sense for their facilities (i.e., traversing the full length of the building to get to the freezers or reducing the distance with replication of a freezing area).
Location. Location. Location.
We have heard it before, the common phrase for buying and selling real estate. Sometimes, we need to step back and recognize that building a cell therapy facility is ultimately a real estate transaction. Buying property, leasing space, or repurposing an existing facility sets a fundamental basis for the facility's design and ultimate function.
Some questions to consider when evaluating a location include:
- Does the location offer access to enable staffing the facility with the right talent?
- Is co-location with R&D needed for ease of technology transfer and continued process development?
- Are there other company functions that should be co-located for business reasons?
- How does the location work for the logistics of vein-to-vein delivery?
- Is there a financial incentive (e.g., lower cost space, government funding, tax breaks, recoveries on depreciated assets)?
In one case, a company chose a vertically oriented facility for an advanced therapy medicinal product (ATMP) program that spread their operations across multiple floors. The small footprint of each floor made process transitions less than ideal. However, the financial support from the local city government drove the selection of the site and its planned use of an existing, vertical facility. There are many instances where government support doesn’t drive massing based on the site. For instance, another facility IPS completed followed a horizontal approach to allow for multiple small, independent suites to receive government funding within a start-up incubator space.
As we think about space, we need to consider the timeline and allocated capital. Many cell therapy products are racing to commercial launch, driving us to look at existing buildings. These buildings can range from a high-rise medical building in an urban center to a shell building originally intended to be a warehouse. One facility IPS completed was a renovation of an idled packaging facility. Getting into an existing shell was one of the key factors that allowed the project to go from concept to full installation in 11 months.
Speed to market is especially important in the cell therapy space, but it should not be the singular focus. For example, another consideration might be master planning for scale-out/up for long-term production needs. Horizontal facilities can provide a straight-forward expansion using a mirroring approach or by adding modules. A modular cleanroom system is another consideration when rapid builds are needed. While modular cleanrooms have been successfully used in vertical facilities, there can be additional design challenges due to available free height. These challenges don’t disappear with traditional cleanroom construction; however, the time to design and build adaptive solutions can lead to a slower and more costly delivery than equivalent space in a horizontal facility.
Determining the Right Solution
Choosing between a vertically and horizontally oriented site can be challenging, because many times we are forced to prioritize one requirement over another. In a further IPS example, a company started with an initial design to renovate space in a high-rise medical building they occupied in the downtown area of a U.S. city. The advantage of this approach was the proximity between manufacturing and the company’s researchers and clinical trial participants. However, the disadvantage was that the cost and complexity of the renovation outweighed the advantages of proximity. Based on the business case analysis, the determination was made to design an expansion at a CMO’s single-story (horizontal) facility outside of the city to accommodate the increased demand.
Finding the right approach for your next cell therapy facility can be distilled to the following:
- Horizontal designs:
- Straight-forward scale-out
- Lower first cost
- Vertical designs:
- More efficient use of land
- Proximity to talent pool and resources
- Opportunity to build in other company functions
- Purposeful separation of operations by floor needed
- Other out (horizontal) vs. up (vertical) drivers:
- Existing assets
- Available real estate
- Local land-use regulations
- Proximity to supply chain (particularly for autologous therapies)
There isn’t a universal, “one solution fits all” answer to which direction is the best. Finding the right partner to help you navigate through options to determine whether to go up or out is a valuable next step to finding the right solution, which will be driven by several factors that are unique to your needs.