All you need to know about off-site modular fabrication of biopharma manufacturing facilities
As the biopharma industry becomes more technologically advanced, it is also driving the demand for innovative solutions to optimise drug development costs. It is demanding improvements in the construction delivery process. And it is demanding that the trickle-down effects of these advances reach every person in the world.
In other words, as the biopharma industry becomes more advanced, it is imperative that access to the products it makes also improves significantly.
Released some years ago, the Modular Facilities in Pharmaceutical/Biotechnology Industry, 2017-2030 report forecasted annualised growth of 8.9% between 2020 and 2030 for the biopharma modular facilities market.
If you haven’t yet hopped onto this growing trend, or are hesitating to do so, we understand there are reasons for it. More often than not, those reasons involve unfamiliarity, insufficient knowledge, or a lack of understanding of how prefab factories can work in an industry that still relies on traditional construction to a large extent.
Let’s change that. Let’s take a look at some of the basics – trends in the biopharma industry, the features and benefits of modular factory systems, the adaptations you will have to make if you choose to go the prefab route, and how you can make the most of this revolution in construction delivery.
Let’s dive right in.
Trends driving the growth of prefabrication in biopharma manufacturing
Like manufacturing in all industries, emerging technologies are transforming the face of biopharma production. Moreover, the desire to expand into more markets has called for increases in efficiency, decreases in operating costs, and shorter timelines for drug development. Modular pharma factory construction supports all these goals.
Nevertheless, this isn’t just about market expansion or using technology for technology’s sake. Recent developments in the biopharma world have set the stage for modular construction to achieve a foothold and expand sustainably in the years to come.
For starters, some important biological drugs are nearing their patent cliffs. As the predicted demand for biosimilars increases, many relatively small manufacturers will want to meet this demand through flexible, efficient and cost-effective factory solutions i.e. modular pharma factories.
Biopharma contract manufacturing organisations (CMOs) are also expected to expand their capacity to keep up with the overall growth in the biopharma sector, predicted at over 12% annually.
The trend towards modular pharma factories is not only being driven by but is also driving growth in the biopharma space. For instance, single-use systems used in continuous production campaigns are capitalizing on the use of modular facilities to cut down on on-site sterilization, cleaning, and cross-contamination risks.
Essentially, be it across biosimilars, monoclonal antibodies, personalised medicine, or any other emerging biopharma product type, modular pharma factory construction is here to stay.
Features of off-site manufactured modular biopharma factories
Modular, prefabricated or off-site construction refers to the process of manufacturing building components, be they two-dimensional panels or three-dimensional volumetric units, in an off-site factory. These components are then shipped to the location, where they are assembled on-site. While these units are largely standardised, they can also be customised to meet specific requirements.
In the biopharmaceutical world, modular design, fabrication, and factory construction take on added specificity. If an entire manufacturing facility is being built using modular components, the units are ideally fitted with an air handling and HVAC system, fire suppression, insulation, plumbing and other aspects essential for the functioning of the building. These fairly large components are usually shipped to the project site in shipping containers where they are put together, connected to utilities, and then ready to begin production.
If a pharma plant only wants smaller modular process systems, the systems – say, to produce pure steam or water for injection – are designed into portable skids. Portable skids are self-contained units which can be placed in different formations to existing plants. Multiple skids may also be used to form entire manufacturing plants.
Common module configurations include truckable modules, offering great road travel flexibility, for complete modular buildings. There are also skid-mounted process equipment modules, hybrid process skid modules, and plug-and-play pods (say, for cleanroom suites) like the ones we manufacture at PodTech™.
Benefits of modular construction in biopharma manufacturing
The modular nature of prefab factories and their construction in off-site factories lend this innovation in construction delivery many benefits over traditional approaches.
– Modular construction speeds up the time to market for biopharma manufacturers. This is critical when it comes to tackling disease outbreaks, humanitarian crises or other unpredicted demand spikes. Even in ordinary circumstances, modular construction can help biopharma factories beat their competitors and get to market first.
– Since modular components are manufactured in a controlled factory environment, the shape, size and finish quality of the structure can be monitored and guaranteed more easily compared to on-site construction.
– In many situations, it is difficult for pharma factories to pause operations while the facility is being expanded. With modular extensions, you don’t need production downtime. This minimises manufacturing disruptions.
– Modular factory and process designs can greatly reduce the required manufacturing area. Layouts can also be made more ergonomic, increasing workers’ ease of accessing tools and machines, and increasing productivity.
– Modular facilities are associated with reductions in energy consumption and precision in engineering, which eliminates waste. This makes prefab pharma factories the sustainable option.
– Finally, the unpredictable on-site risks of traditional construction are transferred to a controlled off-site location i.e. the module manufacturing facility. In other words, modular construction offers the benefit of risk minimisation.
Adapting to the modular mindset
Ideally, you should make some adaptations to your way of doing business to make the most of modular pharma factory construction.
– It helps to transition from the traditional design phases of concept, basic design etc. to early design planning. You can do this by adding flexibility to the design process, allowing it to be managed even on the modular fabrication shop floor.
– Encourage an environment of continuous improvement rather than one-time prototyping. This incremental innovation will keep you at the forefront of technological advancements in the biopharma prefab space.
– Move from relying on niche subject matter experts to learning from interdisciplinary designers and design teams.
– Use real-time digital design tools to optimise the modularisation process.
– Curate an integrated factory team. Instead of separating individuals into project functions, it helps to have the integrated team implement an early integrated project delivery model.
Additional dimensions to setting up a modular factory
Finally, there are a few added dimensions to keep in mind when setting up a modular factory – factors that don’t come into play in traditional construction.
– Plan the transportation route of your pods and on-site logistics to ensure everything complies with the shipping requirements of authorised routes.
– If your factory modules are being manufactured in a different country or region than the location of your factory, take into consideration communication barriers that may arise due to time zones, language, culture, and management systems.
– Define the factory and site acceptance test (FAT and SAT) criteria with your equipment vendor at the three required locations: equipment vendor shop, modular fabricator shop, and your factory site.
As the steady growth of modular pharma manufacturing reveals, biopharma manufacturers are experiencing measurable benefits from off-site construction. Given its higher degree of predictability, flexibility, scalability and resource efficiency, it is emerging as a strong rival to brick-and-mortar construction. Ultimately, as biopharma projects increase in complexity, modularisation will be the go-to solution to setting up drug, vaccine and diagnostics factories.