Time to market is critical, especially when it comes to cancer treatment. Cell and gene therapy clients across the world are rapidly moving through advanced clinical trials and time is of the essence.
Challenge
Regardless of what stage your organization is in, pre-trial, clinical trial or post approval, planning for production must begin early in the process. When it comes to manufacturing your product, a decision must be made. Will you keep your manufacturing in-house or outsource to a CDMO? The answer is not always clear. There is no straight forward formula when it comes to making that decision. Ultimately, the decision must be aligned with your overall business strategy and product pipeline. Our client, a pre-clinical stage biotechnology company, came to that crossroad.
Solution
Given the complexity of designing and building a viral vector manufacturing facility, they engaged CRB to provide a detailed understanding of the process and the steps required for manufacturing operations. After evaluating their overall project goals and business drivers, we landed on a feasibility study for CRB’s turnkey solution, SlateXpace.
Our study provided a comprehensive report that could be presented to leadership to help make the case for an in-house manufacturing facility.
Results
The SlateXpace programming study concluded that our client could save up to 50% on overall project schedule (compared to a traditional design-bid-build project delivery) or 20-30% versus an IDP execution model. Additionally, the initial feasibility study report was delivered to the client in 1/3 the amount of time compared to a fully customized facility design with the same level of estimate accuracy (+25%/-10%)
The process
To move fast, you must be flexible. This means that where project owners once followed a straight line from the process flow diagram to the building’s layout, they must now design for the unknown, taking into consideration a holistic set of factors that include business objectives, research pipelines, sensitivities to risk, and emerging technologies. By the time they’re complete, these new facilities may well host processes and/or equipment platforms that haven’t yet been invented. To get the most from their capital expenditure, project owners need to ready their life science facilities for these changes by building agility into their layouts, process designs, and equipment platforms. We did that for you.
Emerging approaches to capital project delivery that emphasize agile and scalable manufacturing solutions are pushing more linear approaches aside. SlateXpace answers this challenge with a suite of templated, hyper flexible product-agnostic cleanroom modules.
Here’s how we do it:
1. We start with a design that is 80% complete
2. Listen to your vision, project drivers and biggest challenges
3. The design is finalized based on your customized needs.
4. We design with modularity in mind. Coupled with integrated delivery this accelerates both design and construction.
5. We don’t stop there. SlateXpace is a full facility solution. Operational readiness guaranteed.
