Your questions answered

After working on more than 350 cell and gene therapy (C&GT) projects, CRB’s integrated team of engineers, architects, and constructors began to see a convergence of trends within the market and asked, “Why do we keep starting from scratch?” When a CRB survey of nearly 150 leaders in cell and gene therapy innovation revealed that 60 percent of manufacturers planned to adopt a multi-modal solution within two years, it was clear a dramatic shift was taking place.

The concept was borne from our team’s desire to innovate an elegant and unique solution to address the pressing flexibility needs of the C&GT marketplace and to deliver it in the most streamlined way possible. The result is SlateXpace (pronounced Slate-Space”), a customizable modular approach that offers an agile alternative to traditional, dedicated manufacturing.

“Modular” doesn’t mean one-size-fits-all. Our team works hand-in-hand with each client to customize their SlateXpace platform to precisely meet their business and operational needs, both in terms of their current and anticipated product portfolio and within the context of the host facility. Much like a building-block set, we provide a wholly unique solution built from a curated kit of parts that streamlines the decision-making process and focuses your attention on the topics that matter most.

We pair this building-block approach with a “blended delivery” of various construction delivery methods—modular, panelized, and stick-built—mixed in the exact ratio needed to achieve your business goals. SlateXpace modules are built off-site with our trusted trade partners whom we engage and integrate early, ensuring cost- and schedule certainty from day one. The result is a highly flexible solution that deploys quickly and continuously adjusts to meet your evolving needs.

Those are cleanroom-only solutions, offering a simple enclosure and limited environmental control. Your business doesn’t stop at the cleanroom boundary—and neither do we. We work with you to provide a fully integrated and operational facility that meets your specific business drivers. Our team of experienced process engineers, process architects, and operational improvement specialists have the regulatory knowledge and experience to create an agile facility that operates at peak performance today while having the ability to grow with your business. Our main goal is to take the “what-if” worry of the unknown off your hands, not sell you a “one-size-fits-all” solution. While most modular cleanroom vendors will guarantee environmental conditions within their cleanroom boundary, CRB will deliver a full GMP licensable facility.

SlateXpace modules are built off-site with our trusted trade partners (Germfree, PCI, and CAI) whom we engage and integrate early, ensuring cost- and schedule certainty from day one. The result is a highly flexible solution that deploys quickly and continuously adjusts to meet your evolving needs.

We leverage the best of CRB’s 35+ years of GMP facility design experience, which includes over 350 cell and gene therapy products and utilize industry-leading experience and design practices. We’ve been involved with the advanced therapy market since its inception. CRB has stood by its products for over 35 years, and SlateXpace is no exception.

Our design approach starts with your process needs (or what you know of them) and works outward from there. We place an early emphasis on facility GMP flows and HVAC pressure, zoning, and environmental classifications. The preliminary design concludes with a risk assessment to identify and mitigate potential areas of regulatory scrutiny—helping streamline compliance when it comes time for inspection. CRB is there to assist you at every step—from project inception through operational readiness. We define success as the opportunity to be your trusted partner through production, optimization, and future expansion.

Yes, very likely. The modalities we’ve successfully test-fitted include viral vectors, plasmids, monoclonal antibodies, vaccines, allogeneic and autologous cell therapies, mRNA therapies, and associated fill finish activities. We continue to find new applications for this platform on a regular basis.

Projects should be Process Development, Pre-clinical, Clinical or Commercial facilities – utilizing single-use equipment (up to 2000L), and/or small-scale filling operations. To ensure project schedule and budget, a turnkey approach with a single source of responsibility for overall project delivery is highly recommended. Our execution strategy heavily leverages parallel path execution, pre-assembly, prefabrication, modular, and off-site fabrication (PPMOF), Integrated Project Delivery (IPD), and early trade partner engagement. To gain the most from this platform, we encourage an openness to work with these approaches.

Each scenario is different, depending upon a client’s turnover protocol, but the short answer is: a fraction of the time and complexity needed for a traditional facility. Installing or re-configuring a pre-assembled modular unit takes just a few hours or days—compared to months or years for a traditional renovation. The time, cost, complexity, and impact to existing operations you’ve previously endured just to keep up with changing market demands and technological advancements can now be avoided. Building the traditional way is ripe with risks—and offers very little forgiveness when changes occur down the road. SlateXpace is specifically designed for easy decontamination and quick changeover.

Cost varies by project and application. We start by understanding your business goals and provide a cost and schedule estimate to meet those criteria. Our target value delivery approach actively puts the quality where you need it and trims the remaining fat, avoiding painful last-minute value engineering decisions. We also understand the long-term implications of facility ownership and place an emphasis on life-cycle considerations that are too often overlooked or ignored. Our optional capital vs. operational expense analytical services can help you stay profitable in long term and short term alike.

Our competitively-priced modular units have an expected lifespan comparable to a traditional facility; however, because they meet criteria to be considered equipment (not capital infrastructure), the tax value depreciation savings over time can be significant. Paired with the ability to continually adapt, the SlateXpace platform holds tremendous residual value by minimizing future investment requirements.

Absolutely. Choose any combination of our standard SlateXpace models to create the best suites for your project. Each model has a multitude of standard internal layout options available to pick and choose from. Models may even be connected or used in combination with one another to create unique suite configurations that offer greater degrees of openness—or segregation—as desired. Each module is structurally independent and supports all necessary HVAC and utilities on top—allowing full utilization and customization of first floor areas without complex and costly mezzanine structures. Modules may be stacked vertically to provide additional headroom for equipment and processes. For existing conditions with limited vertical clearance, HVAC and utilities may also be provided on the same level as production modules, adjacent or remote.

First, the design offers a clean “slate” every time a manufacturer campaigns between modalities. It’s the same suite but a completely fresh start. The verbal pronunciation of “space” was a pretty straightforward visualization of the volume we’re providing. The “X” factor within the space is the novel ability for the space to be hyper-flexible and adaptable, to accommodate the unknown with ease. Finally, the unspoken “pace” alludes to the long-term benefits of continuous scalability and expansion. It’s a solution that is always right-sized to match your business needs.