The Importance of Reduced and
Predictable Project Timelines
Dennis Powers, Vice President of Sales Engineering and Business Development
Reducing project schedules and completing facility projects on time has never been more important to our industry than it is today. It is critical that drug manufacturers have the capability of and capacity for producing therapies and treatments that are needed by patients around the world. With the spotlight on the new cell and gene therapies that are being launched, and their effectiveness for curing life threatening diseases, the importance of well-controlled project timelines using pre-fabricated modular facility solutions continues to grow.
The Impact of Project Timelines
Historically, most drug manufacturers have followed a traditional facility construction approach with extended project timelines, high onsite complexity, and risks. Very few of the facilities built using this approach were completed on time to their planned schedule and it was not uncommon for a new facility project to take up to 5 years from start to finish. Because of the duration of project schedules and the unpredictability of traditional on-site construction, drug manufacturers have had to make large capital investments in new facilities long before they required the capacity for their drug products. This has posed significant financial risk to the companies under the following scenarios:
- A facility built for a drug product that failed in clinical trials and/or did not get regulatory approval
- A facility delayed in start-up that could not commercially manufacture a new drug product upon regulatory approval
- A facility which was oversized and underutilized for producing a drug product that did not achieve the expected market acceptance
- A facility which was undersized and not capable of meeting the market demand for a drug product.
The Problem with Traditional Facility Schedules
There are many reasons for lengthy schedules and why they get delayed during the design, construction, and commissioning phases of a project. Because most facilities in our industry have been stick-built, each one has been a unique or custom design based on the manufacturers’ requirements, but also on the A&E firm’s experience, design preferences, and desire to differentiate their work. This non-standardized approach requires a significant upfront engineering design effort with multiple stage gates for design reviews and approvals before moving to the next phase.
Traditional stick-built facilities require sequential construction phases where the building shell is first erected, followed by building core and utilities, and finally the critical cleanroom and process infrastructure. This requires the continual planning, coordination, and interaction of multiple sub-contractors and services at the construction site. Due to the complexity there is often a domino effect of construction delays if tasks are not started or completed on time due to permitting issues, material availability, labor shortages, or weather.
The Benefits of a Pre-Fabricated Modular Solution
PODs represent an innovative pre-fabricated modular cleanroom solution that can be effective in avoiding the extended project schedules, delays, and many other issues experienced with traditional construction. The off-site fabrication of the PODs allows for parallel construction activities of both the cleanroom infrastructure and shell building/core which provides a more compressed project timeline. And because the PODs are fabricated in a well-controlled factory environment by an experienced labor force, the risk of schedule delays as well as the number of on-site contractors, staging areas, safety issues, and overall project liability can be significantly reduced. The end result is a shorter and more predictable project timeline that can help drug manufacturers produce the required capacity when they need it. The prefabricated approach also mitigates manufacturers’ financial risks by allowing them to delay their capital investment until months before the capacity is required or until the product is further along in the clinical trial process and with a higher probability for regulatory approval. The pre-fabricated modular approach can help companies prevent the potential loss of millions of dollars in revenue as well as prevent the wasting of millions of dollars in capital to build a facility that cannot be used as planned.