The outlook for the life sciences industry is positive, with lab space under construction in key U.S. markets and commercial properties being reconfigured into life science-based facilities. With demand still outpacing supply, the life sciences industry is looking for speed, flexibility, and agility in its ongoing projects. With tight timeframes in place, ensuring new facilities meet all requirements can be challenging. That is why many organizations are turning to modular construction, risk-based qualification processes, and data and analytics to improve processes and speed-to-market when they design, build, and occupy new workspaces.
The advantages of Modular Construction
Time is of the essence as life sciences companies prepare to get new facilities up and running. Thus, it is vital that new facilities be operational both as quickly and as safely as possible. Biotechnology business leaders may assume that this requires spending exorbitant amounts to build state-of-the-art spaces quickly, as quality and speed-to-market are non-negotiable.
Taking an alternative approach — such as modular construction, pre-manufacturing, and off-site manufacturing — provides end-product quicker than traditional builds. The cost of these properties is more predictable, and unnecessary surprises can be minimized, resulting in more reliable budgets. Modular construction is the practice of having assets, infrastructure, process, piping, equipment, or entire facilities — such as the cleanroom pod — built in a controlled manufacturing space. Products can either be disassembled at the manufacturing space and reassembled at the final site or shipped in a completed state to their destination and installed in the new facility. By switching to modular construction, companies can buy high-quality spaces “off the rack,” start their construction concurrently with the core and shell, and have them shipped, where they can quickly integrate and complete final tie-offs into the overall project. With enough foresight, a company can produce its entire facility and all major components this way, combining modules together to complete construction nearly as soon as it is begun. This also increases the quality of the end-product. Even in instances where the upfront cost of modular construction may be more expensive than traditional builds, the vast advantage in speed and quality can mean buildings are constructed and generating return-on-investment 30 percent or 50 percent sooner.
Other advantages of modular construction include the ability to increase manufacturing spaces without having to shut down production. Since the space is built off-site in advance of getting to the facility, it can easily be added to a space and integrated into the facility. Throughout the pandemic, this process was used in facilities that were manufacturing COVID-19 vaccines to ensure that space and production could increase as more vaccines were developed. It also allowed for fewer individuals on-site at a time, which was essential for physical distancing guidelines.
Risk and reward
When working fast to build and occupy a new facility, companies may rush decisions without considering certain key risks that could prove disastrous if not anticipated. With risk-based qualification, life sciences organizations can have a full risk analysis report before construction begins. This is especially necessary with the machines and equipment needed at life sciences facilities to research, develop, and mass-produce new pharmaceutical solutions. Therefore, companies need to advocate for risk-based qualification processes throughout the project lifecycle.
Currently, approval for testing products and facilities is siloed. After buildings are completed, and equipment has been procured, the FDA is brought into the process to verify the safety of the facility and the manufacturing process. This can lead to huge delays between project completion and the ability to use the facility. With risk-based qualification, approvals are built into the scheduling process and are completed in tandem with the construction process, starting at the beginning of the build. This provides an integrated project-delivery process that allows facilities to be fully functional by the completion date. Although some testing may still be needed after the project is complete, it can dramatically speed up timelines for life sciences projects.
Data-driven decision-making
Data remains crucial for companies as they manage risk and build better facilities. It can be leveraged for data-driven construction and advanced analytics that improve workflows, scheduling, and cost management. Predictive cost data, for example, can pinpoint the cost of construction as early as three years before a project even begins construction, stressing the need to leverage data and analytics early on in the construction planning process. Utilizing modular construction allows a better predictive budgeting process, decreasing the number of contingencies that are saved for project unforeseen items. Modular construction also drives the key programming decisions to be made early on for flow and use scenarios, minimizing the program changes in the future.
Benchmarking data is also available to help organizations understand industry standards for cost and scheduling, helping organizations to normalize cost and schedule data for different regions. By accessing benchmarking data and reports, strategies for pricing, distribution, and timelines help organizations understand what’s in store for them on their projects and how to improve best practices. Being able to set up accurate budgets and schedules for projects helps them run more successfully. Predictable solutions and key stakeholder approval of the program and design allows companies to manage budgets and schedules according to their funding approvals.
Organizations should look towards lighthouse manufacturing sites for technology solutions to capture more data of an operating facility and its real building and manufacturing performance. The first locations of their kind, these sites pilot new ideas and best practices and collect data on how those ideas benefit the company. By paying attention to data collection from such facilities, organizations can prepare for the early adoption of artificial intelligence and machine learning, two trends in manufacturing that have raised cash flow for front-runners by 122 percent, compared to only 10 percent for companies who lagged behind.
Improving the end-user experience
When time is of the essence, it is easy to lose one’s sense of scale and perspective and to cut corners. This is especially true when your job is to run a life sciences company, and you find yourself entangled in a construction project, desperately needing to expand space to keep up with demand. Even the most conscientious biotechnology leaders may miss some detail or best practice, resulting in higher costs and longer timelines. By knowing the latest metrics and best practices, biotechnology companies can complete projects or extend existing facilities during this critical time for the industry. These strategies could mean the difference between costly delays and bringing new lifesaving breakthroughs to the market quickly.
