In the high-stakes pharmaceutical industry, time is a currency. The faster a biotech facility can rise from the blueprints, the quicker therapies can go from research to market, boosting return on investment and, crucially, patient access to new treatments.
At the forefront of procurement — for CEOs, engineers, and investors alike — the challenge is clear.
How do you accelerate construction timelines without compromising the stringent compliance demanded by ISO cleanroom standards, Good Manufacturing Practice (GMP), and Biosafety in Microbiological and Biomedical Laboratories (BMBL), alongside the strict oversight of bodies like the MHRA and FDA?
Today, the use of modular designs and prefabrication methods are increasingly being recognised as cost-effective solutions to these challenges, cutting down on building times and allowing pharma companies to start trials or get into drugs production quicker.
“Working quickly to design and build biotech facilities that enhance health outcomes is incredibly motivating,” says Hugo Testa, Technology Director of Merit, a UK specialist in industrialised construction and digital manufacturing for the life sciences sector.
Merit is part of a new generation of offsite construction providers for the biotech industry. Its proprietary platform design features industrialised integration and an offsite approach that uses advanced technology, robotics and automation to quickly deliver fully accredited and ready-to-go facilities.
It produces two types of prefabricated units. It’s UltraPOD® product, arrives ready for on-site installation, complete with essential systems like wiring, plumbing, HVAC and other utilities, ensuring rapid integration into the larger facility. Its FLEXI POD® product provides a hybrid solution combining PODs and Pre Assembled Modules (PAMs) with on-site building methods.
Such designs are now enabling the swift launch of compliant labs and biopharma facilities. Prefabricated units can be made to adapt and grow, making it simple to integrate new tech, streamline processes, or bump up production to keep pace with the changing world of medicine development and manufacturing.
Speed, though, counts for little, stresses Testa, without proper expertise of biotech workflows and processes from the initial design stages. “We quickly realised that grasping client-specific biotech processes early on is key to building any biopharma facility,” he explains.
“It determines the necessary clean room standards and informs the mechanical and electrical (M&E) infrastructure needed for critical controls such as precise temperature and humidity regulation. It’s only when you’ve pinned down the equipment and utility matrixes that you can begin to design backwards from the room to the plot.”
Modular spaces are designed to be adaptable to meet various process requirements. They include features for environmental monitoring, maintaining pressure differentials, and incorporating energy-efficient solutions, all while providing easy access for maintenance.
The HVAC systems in these facilities are flexible, designed to allow clean rooms to operate under either positive or negative pressure cascades. This flexibility ensures that environmental conditions can be controlled to prevent contamination or to contain hazardous materials within specific areas, as required.
“Merit’s designs can allow for clean rooms to operate under positive or negative pressure cascades, depending on the need to either keep contaminants out or contain harmful particles within for different research and production requirements,” Testa explains.
With advanced Building Information Modelling (BIM) crafting detailed 3D models to millimetre accuracy, modular design is proving to be an evolutionary leap in construction for the biotech industry, echoing genetic sequencing’s precision. Its tools allow virtual alterations, rather like gene editing, before construction begins — saving time and resources and giving clients a clear view of each step in the building process.
“By producing ‘digital twins’ of the products and by manufacturing them in the controlled environment of a factory, modular construction can be approximately three times faster than traditional methods of producing a new biopharma facility,” says Testa.
The modular approach also trumps traditional project management when it comes to cost estimation — typically a complex and bottleneck-prone phase in design. It overturns the old notion that “the budget may not be the final budget,” offering clients the certainty of fixed prices early on, despite material shortages and high inflation.
Merit’s Virtual Design Construction (VDC) team has been behind several flagship UK biomedical facilities for prominent clients like Autolus Therapeutics, Moderna, GSK, the Francis Crick Institute and CPI.
Molly MacDonald, Merit’s VDC Architectural Assistant Manager, details the company’s methodology. “Before we assemble anything, we bring together all the stakeholders … we want to be sure everyone is involved from the start as we begin work on the URS,” MacDonald says.
“With UltraPOD®, there’s no requirement for steel work. They can literally be taken to the site, fully fitted with all the M&E, and connected like Lego,” she explains. “Our FLEXI POD® product requires steel work, but they too are essentially plug and play.”
This approach achieves a high pre-manufactured value, typically between 75-90%, showing how offsite construction can significantly speed up the building process beyond traditional methods.
“When we work with our clients, our BIM models mean that our clients can really understand their buildings,” adds MacDonald. “This information can be used throughout the entire lifecycle of the building, from the initial design and construction phases to ongoing maintenance, right down to how long the LED lights will last and how to replace them.”
With medicines manufacturing being a substantial contributor to the life sciences sector and considering the expected growth in the global vaccines market, the strategic emphasis on modular design in facility construction is well-placed.
Through an offsite construction approach, the construction landscape of biotech facilities is being reshaped – to create spaces that not only further scientific progress but that are also designed with the future in mind: adaptable, sustainable and transformative.