The Covid-19 pandemic changed everything — including how we approach health care and medical research. The urgent need for effective treatments and vaccines has propelled the life science industry into the spotlight, with scientists, researchers and manufacturers working tirelessly to develop and produce life-saving therapies.
This has created a surge in demand for manufacturing life science (MLS) facilities across the United States, as companies seek to expand U.S. manufacturing through reshoring, onshoring and friend-shoring practices, and to increase production capacity fueled by U.S. government investments in the Inflation Reduction Act of 2022 and the Science Act of 2022. The United States has invested heavily in government manufacturing incentives to support onshoring and reshoring as well as green energy incentives.
Investments and industrial strategies such as Manufacturing 4.0 are revitalizing domestic MLS, creating good-paying American jobs, strengthening American supply chains, and accelerating the industries of the future. Last year was a record-breaking year for U.S. manufacturing with $108 billion in factory construction.
“Coming out of Covid, there was a concern and a need to command our own supplies especially with supply chain disruptions and deglobalization,” says Andy Ahrendt, PCL’s director of advanced manufacturing. “This has fueled new demand for domestic investment in MLS, especially pharmaceutical production, medical supplies, and critical care supply production.”
This rising demand, boosted by government action like the Reinvestment Act, means more life science businesses than ever are considering how and where to build new manufacturing facilities. PCL subject matter experts share what producers should look for in a design and construction partner when it comes to advanced manufacturing facilities.
MLS is an astonishingly broad field. It covers everything from facilities that develop gene editing technology and vaccines to those that produce medical devices or cosmetics.
“It is amazing what the life science industry is developing. Some of it can even seem like science fiction,” says Ahrendt. “My dad had a heart valve put in, for example, that was grown in a lab. It was a pig valve that was gene edited and ultimately extended his life another seven years.”
Despite the diversity of products, all MLS projects have some similarities.
For example, virtually every MLS facility requires cleanrooms and current Good Manufacturing Procedures (cGMP).
Clean rooms range from Class 100,000 to Class 1, which is the cleanest. A cleanroom’s Class identifies the number of microscopic airborne particles, measured as 0.5 microns, permitted per cubic foot of air in a room. Consider that a human hair is about 75 microns in diameter and a dust particle can be five microns or less. The human eye can detect particles around the 50-micron mark.
CGMPs are the manufacturing practices workers must follow within clean room facilities to maintain a clean environment and ensure product integrity. This is done through standard work practices such as gowning and personal protective equipment, removal of jewelry and cosmetics, highly filtered ventilation and air conditioning systems, and facility controls such as air locks.
“The requirements for cleanrooms and cGMP are achieved through rigorous planning, special construction procedures, monitoring, testing and validation,” says Mike Osowski, a senior project manager with PCL’s Minnesota team and a veteran of many life science builds.
From 40 years of experience building advanced manufacturing facilities, PCL has developed their own Cleanroom Protocol Procedures. For example, PCL phases construction activities with escalating cleaning requirements and site controls for each new phase, all to maintain a clean environment. Concrete and drywall work happen in phase one. Walls and floors are finished in phase two. Then comes “blowdown,” where pressured air scours all surfaces on the site to remove any remaining construction debris. Phases three and four require workers to wear sanitary gowns, and masks and coverings.
The procedures, along with PCL’s familiarity with the cGMP standards Osowski mentioned, are a detailed set of instructions for achieving the level of cleanliness a facility requires and ensure final product integrity.
Experience can make all the difference for clients looking for the right construction partner in the high-stakes and complicated world of MLS.
“We can bring the right people and tools to each project to provide the best value for the client,” says Osowski.
PCL’s MLS teams have built projects of almost every size and description for clients. These include facilities with four biohazard safety levels. Each level has specific controls for containment of microbes and biological agents. The primary risks that determine levels of containment are infectivity, severity of disease, transmissibility and the nature of the work conducted. Recent notable projects include the JC Wilt Infectious Diseases Research Centre in Winnipeg, the Bayer Cleanroom in Coon Rapids, Minnesota, and the International Microbiome Centre Germ Free Facility at the University of Calgary.
Early contractor involvement — preferably at the beginning of concept design — can make a tremendous difference to a project’s ultimate success.
On the Bayer facility, PCL’s collaborative team worked closely with operations and engineering up front to develop a cost-effective design and construction strategy to meet the occupancy goals.
“It’s imperative to find a construction partner wanting to get involved in a life science project well before shovels hit the ground - whether your process is harvest/clarification, production bioreactor, seed train or formulation and bulk fill,” says Ahrendt. “On a recent life science project, PCL was involved early in reviewing building requirements and constructability. Once we understood the owner’s process and equipment requirements, balance of plant, air handler, chiller sizing as well as process waste and containment can be designed. Everything derives from the process.”
Ahrendt explains how understanding FDA and governmental facility certification requirements, along with understanding the clients’ vision early on, sets up a project for success.
“We start with commissioning, qualification and validation and pull backwards to develop the schedule. Production start-up dictates long lead ordering and activities early in the project which, if not ordered, may impact start-up success,” says Ahrendt.
PCL saw this firsthand on the JC Wilt project where they worked closely with the client to order process equipment and lab casework in advance — a contributing factor to a successful project.
MLS is on the rise in North America. Building these complex, sophisticated facilities is best done with an experienced team who understands life science construction and views the client’s production start-up success as their own.