Modularization offers a new paradigm for advanced therapy medicinal products (ATMP) facility design. It provides innovative solutions that support the design and delivery of flexible, scalable facilities to accommodate changes in production volumes and emerging technology.
Modularization requires a change in mindset. At the heart of the modular approach is the repetitive use of standardized components in design and construction. The more repetitive the use of standardized components, the more modular the facility becomes, allowing for reduced customization and complexity and greater flexibility for a variety of process applications.
By buying in to the modular philosophy and implementing this design and construction strategy, biopharma companies can save costs, maximize efficiencies and accelerate project delivery timelines. Ultimately, this approach will support increased production of potentially life-saving treatments and therapies.
Enhancing flexibility and scalability
Modularization is a particularly relevant project delivery technique due to the rapid evolution and increased output of ATMP processes. The increase in production of these medicines creates the need for facilities that can adapt to changes in a structured way – and modularization provides the necessary flexibility and scalability to support such rapid shifts.
From a facility design perspective, modularization is also important as it accommodates the increasing use of closed systems and optimization technologies such as AI, automation and robotics. The adoption of these new technologies is essential in achieving significant increases in facility output and aids in the discovery and development of emerging medicines. While the next generation of cell-therapy 'open' processing may require multiple pieces of equipment on one bench, advances in technology mean that next-generation processing will deploy a “closed” process fully integrated into one piece of equipment.
In this context, modularization can also be viewed as optimizing manufacturing. For example, instead of making product for 200 patients a year, a modularized facility using next-generation equipment and a modular 'scale-out' expansion approach has the potential to significantly increase production to 2,000 patients a year, regulatory requirements notwithstanding.
From a safety and quality perspective, modularization also makes it possible for pre-construction to take place in a shop-controlled environment. This approach provides a secure setting where assembly and quality control for special systems are better accomplished. Working in a shop environment also means that prequalification activities can be achieved ahead of installation.
This approach mitigates the risk of delays that typically occur during the construction phase, as the availability of standardized components minimizes lead-in times and supports on-schedule delivery.
Accelerated project delivery
At the start of a project, it is important to define how modularization can support a biopharma project – and to set expectations around what parts of a facility can be modularized. To achieve these deliverables, and to align on project metrics that this shift in thinking will yield, there is a need to put a modular mindset at the heart of master planning.
This will support standardization where it can have the greatest impact on the project – e.g. mechanical, electrical and plumbing (MEP) system design and cleanroom system integration – and provides the ability to assemble systems through pre-construction.
Modularization delivers tailored solutions for a new type of biopharma facility. Projects that are designed using this approach can standardize the design of interconnected piping systems and utility panel locations.
Against this backdrop, modularization creates a cleanroom delivery model that increases flexibility and reduces project delivery risk. Leveraging new technology, single-use equipment and closed process steps, modularization also makes projects less complex and maximizes their performance through repetition of a refined process module approach.
And with manufacturing demand for ATMP products increasing, modularization delivers flexible and code-compliant solutions. It also makes it possible to scale out facilities in a repetitive manner — a particular advantage for ATMP products, which tend to be manufactured on a smaller scale.
Specifically, it focuses on the development of customizable process modules that allow for manufacturing to be tailored to meet specific product requirements. This level of customization also enhances efficiency by eliminating unnecessary steps and optimizes the production line for each product. It is also structured in a way that supports biopharma companies to achieve scalability at a faster pace.
Facilities designed using a modularized approach also provide greater flexibility. They can be easily adapted to accommodate changing production volumes, ensuring that their size and capacity align with market demands - without the need for extensive modifications.
Additionally, the greater use of offsite construction methods and pre-assembled systems reduces on-site complexities and reduces the overall project delivery schedule.
Offsite parallel construction also achieves considerable cost savings, while the modularized approach reduces design costs by using vendor “know how” to complete and integrate the design of modular systems.
The ability to reduce design costs is especially valuable when biopharma companies are planning for multiple projects and facilities. For example, standardized sizes of chillers and air handling units (AHUs) in each facility support a standardized modular design platform approach that can be refined as projects are delivered over time.
A new paradigm
Modularization delivers a new paradigm for facility design. It supports the growing demand for ATMP manufacturing and the increased use of technology in the discovery and design of emerging medicines.
With a focus on repetition, off-site parallel construction activities in a shop-controlled environment and customizable process modules, it delivers safety, scalability and flexibility, a compelling combination that reduces costs, maximizes efficiencies and optimizes manufacturing.
Most importantly, it supports biopharma companies as they seek to develop potentially life-changing treatments and therapies at scale and at an accelerated pace, to the benefit of patients worldwide.
